Ignite Creation Date:
2025-12-24 @ 11:05 PM
Ignite Modification Date:
2026-01-03 @ 10:00 PM
Study NCT ID:
NCT02927769
Status:
COMPLETED
Last Update Posted:
2025-02-10
First Post:
2016-10-06
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
A Study of Nivolumab Plus Brentuximab Vedotin in Patients Between 5 and 30 Years Old, With Hodgkin's Lymphoma (cHL), Relapsed or Refractory From First Line Treatment
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24', 'submissionTracking': {'firstMcpInfo': {'postDateStruct': {'date': '2024-11-26', 'type': 'ACTUAL'}}}}, 'conditionBrowseModule': {'meshes': [{'id': 'D006689', 'term': 'Hodgkin Disease'}], 'ancestors': [{'id': 'D008223', 'term': 'Lymphoma'}, {'id': 'D009370', 'term': 'Neoplasms by Histologic Type'}, {'id': 'D009369', 'term': 'Neoplasms'}, {'id': 'D008232', 'term': 'Lymphoproliferative Disorders'}, {'id': 'D008206', 'term': 'Lymphatic Diseases'}, {'id': 'D006425', 'term': 'Hemic and Lymphatic Diseases'}, {'id': 'D007160', 'term': 'Immunoproliferative Disorders'}, {'id': 'D007154', 'term': 'Immune System Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D000077594', 'term': 'Nivolumab'}, {'id': 'D000079963', 'term': 'Brentuximab Vedotin'}, {'id': 'D000069461', 'term': 'Bendamustine Hydrochloride'}], 'ancestors': [{'id': 'D061067', 'term': 'Antibodies, Monoclonal, Humanized'}, {'id': 'D000911', 'term': 'Antibodies, Monoclonal'}, {'id': 'D000906', 'term': 'Antibodies'}, {'id': 'D007136', 'term': 'Immunoglobulins'}, {'id': 'D007162', 'term': 'Immunoproteins'}, {'id': 'D001798', 'term': 'Blood Proteins'}, {'id': 'D011506', 'term': 'Proteins'}, {'id': 'D000602', 'term': 'Amino Acids, Peptides, and Proteins'}, {'id': 'D012712', 'term': 'Serum Globulins'}, {'id': 'D005916', 'term': 'Globulins'}, {'id': 'D009842', 'term': 'Oligopeptides'}, {'id': 'D010455', 'term': 'Peptides'}, {'id': 'D002087', 'term': 'Butyrates'}, {'id': 'D000144', 'term': 'Acids, Acyclic'}, {'id': 'D002264', 'term': 'Carboxylic Acids'}, {'id': 'D009930', 'term': 'Organic Chemicals'}, {'id': 'D009588', 'term': 'Nitrogen Mustard Compounds'}, {'id': 'D009150', 'term': 'Mustard Compounds'}, {'id': 'D006846', 'term': 'Hydrocarbons, Halogenated'}, {'id': 'D006838', 'term': 'Hydrocarbons'}, {'id': 'D001562', 'term': 'Benzimidazoles'}, {'id': 'D006574', 'term': 'Heterocyclic Compounds, 2-Ring'}, {'id': 'D000072471', 'term': 'Heterocyclic Compounds, Fused-Ring'}, {'id': 'D006571', 'term': 'Heterocyclic Compounds'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'Clinical.Trials@bms.com', 'phone': 'Please email', 'title': 'Bristol-Myers Squibb Study Director', 'organization': 'Bristol-Myers Squibb'}, 'certainAgreement': {'otherDetails': "Bristol-Myers Squibb Co. agreements with investigators vary; constant is our right to embargo communications regarding trial results prior to public release for a period ≤60 days from submittal for review. We will not prohibit investigators from publishing but will prohibit the disclosure of previously undisclosed confidential information other than study results, and request postponement of single-center publications until after disclosure of the clinical trial's primary publication.", 'restrictionType': 'OTHER', 'piSponsorEmployee': False, 'restrictiveAgreement': True}}, 'adverseEventsModule': {'timeFrame': 'Participants were assessed for All-Cause Mortality from first dose until study completion (assessed up to approximately 86 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed for an average of 7 months up until a maximum of 10 months).', 'description': 'All-Cause Mortality, Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication. Data prespecified to be reported per treatment modality received in:\n\n1. induction phase and consolidation phase only for those who did not progress to intensification phase in each cohort.\n2. induction phase, intensification phase, and consolidation phase for those who proceeded to the intensification phase in each cohort.', 'eventGroups': [{'id': 'EG000', 'title': 'Cohort 1: Relapsed/Refractory Classic Hodgkin Lymphoma - Low Risk Relapse (Nivo + Bv)', 'description': 'Participants started in the induction phase and received nivolumab + brentuximab vedotin (N+Bv) for 2 cycles (6 weeks). Participants with radiographic progression, as assessed by Investigator at Cycle 2 entered follow-up. The rest of the participants continued in the induction phase and received 2 additional cycles of N+Bv study therapy (total 4 cycles = 12 weeks).\n\n\\- Participants who had a complete metabolic response (CMR) by BICR after a total of 4 cycles (12 weeks) of N+Bv received an additional 2 cycles of treatment of N+Bv (for a total of 6 cycles \\[18 weeks\\]), followed by Radiation Therapy (RT) (consolidation phase).', 'otherNumAtRisk': 22, 'deathsNumAtRisk': 22, 'otherNumAffected': 18, 'seriousNumAtRisk': 22, 'deathsNumAffected': 0, 'seriousNumAffected': 6}, {'id': 'EG001', 'title': 'Cohort 1: Relapsed/Refractory Classic Hodgkin Lymphoma - Low Risk Relapse (Nivo + Bv) + (Bv + B)', 'description': 'Participants started in the induction phase and received nivolumab + brentuximab vedotin (N+Bv) for 2 cycles (6 weeks). Participants with radiographic progression, as assessed by Investigator at Cycle 2 entered follow-up. The rest of the participants continued in the induction phase and received 2 additional cycles of N+Bv study therapy (total 4 cycles = 12 weeks).\n\n* Participants who had a complete metabolic response (CMR) by BICR after a total of 4 cycles (12 weeks) of N+Bv received an additional 2 cycles of treatment of N+Bv (for a total of 6 cycles \\[18 weeks\\]), followed by Radiation Therapy (RT) (consolidation phase).\n* Participants without a CMR after 4 cycles of N+Bv, by BICR, entered the intensification phase and received 2 cycles of brentuximab + bendamustine (Bv+B); participants who achieved CMR after these 2 cycles proceeded with RT (consolidation phase).\n* Participants who had radiographic progression after Cycle 4 N+Bv, as assessed by BICR, or those who did not achieve CMR, by BICR, after 2 cycles of Bv+B were taken off study treatment and entered follow-up.', 'otherNumAtRisk': 6, 'deathsNumAtRisk': 6, 'otherNumAffected': 6, 'seriousNumAtRisk': 6, 'deathsNumAffected': 0, 'seriousNumAffected': 3}, {'id': 'EG002', 'title': 'Cohort 2: Relapsed/Refractory Classic Hodgkin Lymphoma - Standard Risk Relapse (Nivo + Bv)', 'description': 'Participants started in the induction phase and received nivolumab + brentuximab vedotin (N+Bv) for 2 cycles (6 weeks). Participants with radiographic progression, as assessed by Investigator at Cycle 2 entered follow-up. The rest of the participants received 2 additional cycles of N+Bv study therapy (total 4 cycles = 12 weeks).\n\n\\- Participants who had complete metabolic response (CMR), by BICR, after a total of 4 cycles (12 weeks) of N+Bv proceeded with high-dose chemotherapy followed by an autologous stem cell transplant (HDCT/ASCT) (consolidation phase). Participants with CMR had the option to receive up to 2 additional cycles of N+Bv if their HDCT/ASCT was postponed for any reason.', 'otherNumAtRisk': 33, 'deathsNumAtRisk': 33, 'otherNumAffected': 33, 'seriousNumAtRisk': 33, 'deathsNumAffected': 0, 'seriousNumAffected': 11}, {'id': 'EG003', 'title': 'Cohort 2: Relapsed/Refractory Classic Hodgkin Lymphoma - Standard Risk Relapse (Nivo + Bv)+(Bv + B)', 'description': 'Participants started in the induction phase and received nivolumab + brentuximab vedotin (N+Bv) for 2 cycles (6 weeks). Participants with radiographic progression, as assessed by Investigator at Cycle 2 entered follow-up. The rest of the participants received 2 additional cycles of N+Bv study therapy (total 4 cycles = 12 weeks).\n\n* Participants who had complete metabolic response (CMR), by BICR, after a total of 4 cycles (12 weeks) of N+Bv proceeded with high-dose chemotherapy followed by an autologous stem cell transplant (HDCT/ASCT) (consolidation phase). Participants with CMR had the option to receive up to 2 additional cycles of N+Bv if their HDCT/ASCT was postponed for any reason.\n* Participants without a CMR, by BICR, after 4 cycles of N+Bv received 2 cycles of brentuximab + bendamustine (Bv+B) (intensification phase).\n* Participants in CMR, by BICR, after 2 cycles of Bv+B received HDCT/ASCT (consolidation phase).\n* Participants without CMR by BICR could receive 2 additional cycles of Bv+B. If these participants attained CMR, they proceeded with HDCT/ASCT (consolidation phase).\n* Participants with CMR had the option to receive up to 2 additional cycles of B+Bv if their HDCT/ASCT was postponed.\n* Participants who had radiographic progression after Cycle 4 N+Bv, during study treatment or those who did not achieve CMR after final cycle of Bv+B were taken off study treatment and entered follow-up.', 'otherNumAtRisk': 11, 'deathsNumAtRisk': 11, 'otherNumAffected': 11, 'seriousNumAtRisk': 11, 'deathsNumAffected': 1, 'seriousNumAffected': 4}], 'otherEvents': [{'term': 'Anaemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 22, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 6, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 33, 'numAffected': 6}, {'groupId': 'EG003', 'numAtRisk': 11, 'numAffected': 3}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': '27.0'}, {'term': 'Febrile neutropenia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 22, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 33, 'numAffected': 5}, {'groupId': 'EG003', 'numAtRisk': 11, 'numAffected': 4}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': '27.0'}, {'term': 'Leukopenia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 22, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 6, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 33, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 11, 'numAffected': 0}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': '27.0'}, {'term': 'Neutropenia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 22, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 6, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 33, 'numAffected': 2}, {'groupId': 'EG003', 'numAtRisk': 11, 'numAffected': 2}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': '27.0'}, {'term': 'Thrombocytopenia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 22, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 33, 'numAffected': 4}, {'groupId': 'EG003', 'numAtRisk': 11, 'numAffected': 2}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': '27.0'}, {'term': 'Sinus bradycardia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 22, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 33, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 11, 'numAffected': 2}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': '27.0'}, {'term': 'Tachycardia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 22, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 33, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 11, 'numAffected': 0}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': '27.0'}, {'term': 'Hyperthyroidism', 'stats': [{'groupId': 'EG000', 'numAtRisk': 22, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 33, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 11, 'numAffected': 0}], 'organSystem': 'Endocrine disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': '27.0'}, {'term': 'Hypothyroidism', 'stats': [{'groupId': 'EG000', 'numAtRisk': 22, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 33, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 11, 'numAffected': 1}], 'organSystem': 'Endocrine disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': '27.0'}, {'term': 'Eye pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 22, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 33, 'numAffected': 2}, {'groupId': 'EG003', 'numAtRisk': 11, 'numAffected': 0}], 'organSystem': 'Eye disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': '27.0'}, {'term': 'Abdominal pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 22, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 33, 'numAffected': 9}, {'groupId': 'EG003', 'numAtRisk': 11, 'numAffected': 4}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': '27.0'}, {'term': 'Abdominal pain upper', 'stats': [{'groupId': 'EG000', 'numAtRisk': 22, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 6, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 33, 'numAffected': 7}, {'groupId': 'EG003', 'numAtRisk': 11, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': '27.0'}, {'term': 'Coating in mouth', 'stats': [{'groupId': 'EG000', 'numAtRisk': 22, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 33, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 11, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': '27.0'}, {'term': 'Constipation', 'stats': [{'groupId': 'EG000', 'numAtRisk': 22, 'numAffected': 4}, {'groupId': 'EG001', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 33, 'numAffected': 3}, {'groupId': 'EG003', 'numAtRisk': 11, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': '27.0'}, {'term': 'Diarrhoea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 22, 'numAffected': 5}, {'groupId': 'EG001', 'numAtRisk': 6, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 33, 'numAffected': 13}, {'groupId': 'EG003', 'numAtRisk': 11, 'numAffected': 4}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': '27.0'}, {'term': 'Dysphagia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 22, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 33, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 11, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': '27.0'}, {'term': 'Enterocolitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 22, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 33, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 11, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': '27.0'}, {'term': 'Gastrooesophageal reflux disease', 'stats': [{'groupId': 'EG000', 'numAtRisk': 22, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 33, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 11, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': '27.0'}, {'term': 'Nausea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 22, 'numAffected': 9}, {'groupId': 'EG001', 'numAtRisk': 6, 'numAffected': 3}, {'groupId': 'EG002', 'numAtRisk': 33, 'numAffected': 19}, {'groupId': 'EG003', 'numAtRisk': 11, 'numAffected': 11}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': '27.0'}, {'term': 'Oral pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 22, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 33, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 11, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': '27.0'}, {'term': 'Paraesthesia oral', 'stats': [{'groupId': 'EG000', 'numAtRisk': 22, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 33, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 11, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': '27.0'}, {'term': 'Stomatitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 22, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 6, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 33, 'numAffected': 7}, {'groupId': 'EG003', 'numAtRisk': 11, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': '27.0'}, {'term': 'Vomiting', 'stats': [{'groupId': 'EG000', 'numAtRisk': 22, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 6, 'numAffected': 3}, {'groupId': 'EG002', 'numAtRisk': 33, 'numAffected': 7}, {'groupId': 'EG003', 'numAtRisk': 11, 'numAffected': 6}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': '27.0'}, {'term': 'Asthenia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 22, 'numAffected': 4}, {'groupId': 'EG001', 'numAtRisk': 6, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 33, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 11, 'numAffected': 1}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': '27.0'}, {'term': 'Face oedema', 'stats': [{'groupId': 'EG000', 'numAtRisk': 22, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 33, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 11, 'numAffected': 1}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': '27.0'}, {'term': 'Fatigue', 'stats': [{'groupId': 'EG000', 'numAtRisk': 22, 'numAffected': 4}, {'groupId': 'EG001', 'numAtRisk': 6, 'numAffected': 2}, {'groupId': 'EG002', 'numAtRisk': 33, 'numAffected': 7}, {'groupId': 'EG003', 'numAtRisk': 11, 'numAffected': 1}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': '27.0'}, {'term': 'Gait disturbance', 'stats': [{'groupId': 'EG000', 'numAtRisk': 22, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 6, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 33, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 11, 'numAffected': 0}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': '27.0'}, {'term': 'Influenza like illness', 'stats': [{'groupId': 'EG000', 'numAtRisk': 22, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 6, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 33, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 11, 'numAffected': 1}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': '27.0'}, {'term': 'Mucosal inflammation', 'stats': [{'groupId': 'EG000', 'numAtRisk': 22, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 33, 'numAffected': 10}, {'groupId': 'EG003', 'numAtRisk': 11, 'numAffected': 5}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': '27.0'}, {'term': 'Non-cardiac chest pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 22, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 33, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 11, 'numAffected': 1}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': '27.0'}, {'term': 'Oedema peripheral', 'stats': [{'groupId': 'EG000', 'numAtRisk': 22, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 33, 'numAffected': 2}, {'groupId': 'EG003', 'numAtRisk': 11, 'numAffected': 0}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': '27.0'}, {'term': 'Pyrexia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 22, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 6, 'numAffected': 2}, {'groupId': 'EG002', 'numAtRisk': 33, 'numAffected': 17}, {'groupId': 'EG003', 'numAtRisk': 11, 'numAffected': 5}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': '27.0'}, {'term': 'Drug hypersensitivity', 'stats': [{'groupId': 'EG000', 'numAtRisk': 22, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 33, 'numAffected': 2}, {'groupId': 'EG003', 'numAtRisk': 11, 'numAffected': 1}], 'organSystem': 'Immune system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': '27.0'}, {'term': 'Hypersensitivity', 'stats': [{'groupId': 'EG000', 'numAtRisk': 22, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 6, 'numAffected': 2}, {'groupId': 'EG002', 'numAtRisk': 33, 'numAffected': 6}, {'groupId': 'EG003', 'numAtRisk': 11, 'numAffected': 3}], 'organSystem': 'Immune system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': '27.0'}, {'term': 'Infusion related hypersensitivity reaction', 'stats': [{'groupId': 'EG000', 'numAtRisk': 22, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 6, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 33, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 11, 'numAffected': 0}], 'organSystem': 'Immune system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': '27.0'}, {'term': 'Cellulitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 22, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 6, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 33, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 11, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': '27.0'}, {'term': 'Device related infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 22, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 33, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 11, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': '27.0'}, {'term': 'Epstein-Barr virus infection reactivation', 'stats': [{'groupId': 'EG000', 'numAtRisk': 22, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 33, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 11, 'numAffected': 1}], 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'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': '27.0'}], 'frequencyThreshold': '5'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Complete Metabolic Response (CMR) Rate at Any Time Prior to Radiation Therapy by Blinded Independent Centralized Review (BICR) - Cohort 1', 'denoms': [{'units': 'Participants', 'counts': [{'value': '28', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Cohort 1: Relapsed/Refractory Classic Hodgkin Lymphoma - Low Risk Relapse', 'description': 'Participants started in the induction phase and received nivolumab + brentuximab vedotin (N+Bv) for 2 cycles (6 weeks). Participants with radiographic progression, as assessed by Investigator at Cycle 2 entered follow-up. The rest of the participants continued in the induction phase and received 2 additional cycles of N+Bv study therapy (total 4 cycles = 12 weeks).\n\n* Participants who had a complete metabolic response (CMR) by BICR after a total of 4 cycles (12 weeks) of N+Bv received an additional 2 cycles of treatment of N+Bv (for a total of 6 cycles \\[18 weeks\\]), followed by Radiation Therapy (RT) (consolidation phase).\n* Participants without a CMR after 4 cycles of N+Bv, by BICR, entered the intensification phase and received 2 cycles of brentuximab + bendamustine (Bv+B); participants who achieved CMR after these 2 cycles proceeded with RT (consolidation phase).\n* Participants who had radiographic progression after Cycle 4 N+Bv, as assessed by BICR, or those who did not achieve CMR, by BICR, after 2 cycles of Bv+B were taken off study treatment and entered follow-up.'}], 'classes': [{'categories': [{'measurements': [{'value': '92.9', 'groupId': 'OG000', 'lowerLimit': '79.2', 'upperLimit': '98.7'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'From first dose to complete metabolic response or the completion of six cycles of therapy (up to approximately 18 weeks).', 'description': 'The complete metabolic response (CMR) rate is defined as the percent of all response-evaluable participants who, assessed by the BICR, achieved best response of CMR.\n\nComplete metabolic response (CMR):\n\n* Lymph nodes/extralymphatic sites: Score 1, 2, 3 with/without residual mass on 5-point scale\n* New lesions: No\n* Bone marrow: No FDG-avid disease Participants who stopped study treatment early for toxicity without a CMR were evaluable.\n\nConfidence interval is based on the Clopper and Pearson method', 'unitOfMeasure': 'Percent of participants', 'dispersionType': '90% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'All treated participants in Cohort 1. Prespecified to be collected for Cohort 1 only.'}, {'type': 'PRIMARY', 'title': 'Event-free Survival (EFS) Rate at 3 Years by Blinded Independent Centralized Review (BICR) - Cohort 1', 'denoms': [{'units': 'Participants', 'counts': [{'value': '28', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Cohort 1: Relapsed/Refractory Classic Hodgkin Lymphoma - Low Risk Relapse', 'description': 'Participants started in the induction phase and received nivolumab + brentuximab vedotin (N+Bv) for 2 cycles (6 weeks). Participants with radiographic progression, as assessed by Investigator at Cycle 2 entered follow-up. The rest of the participants continued in the induction phase and received 2 additional cycles of N+Bv study therapy (total 4 cycles = 12 weeks).\n\n* Participants who had a complete metabolic response (CMR) by BICR after a total of 4 cycles (12 weeks) of N+Bv received an additional 2 cycles of treatment of N+Bv (for a total of 6 cycles \\[18 weeks\\]), followed by Radiation Therapy (RT) (consolidation phase).\n* Participants without a CMR after 4 cycles of N+Bv, by BICR, entered the intensification phase and received 2 cycles of brentuximab + bendamustine (Bv+B); participants who achieved CMR after these 2 cycles proceeded with RT (consolidation phase).\n* Participants who had radiographic progression after Cycle 4 N+Bv, as assessed by BICR, or those who did not achieve CMR, by BICR, after 2 cycles of Bv+B were taken off study treatment and entered follow-up.'}], 'classes': [{'categories': [{'measurements': [{'value': '87.5', 'groupId': 'OG000', 'lowerLimit': '70.6', 'upperLimit': '95.0'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'At 3 years post first dose of study therapy', 'description': 'Event Free Survival (EFS) is the time from the first treatment to the earliest occurrence of composite events including: Disease progression (PD), Failure to achieve complete metabolic response (CMR) after 4 cycles of N+Bv and 2 cycles of Bv+B, Secondary malignancy, Death .\n\nPD :\n\nLymph Nodes and Lesions: new growth or increase of \\>= 50% in size from nadir. New or growing lesions outside the lymph nodes.\n\nSpleen: Significant increase in spleen size, either from a previously enlarged state or from normal size.\n\nNew Lesions: Yes Bone Marrow: New or returning FDG-avid disease\n\nCMR:\n\nLymph nodes/extralymphatic sites: Score 1, 2, 3 with/without residual mass on 5-point scale New lesions: No Bone marrow: No FDG-avid disease Participants without an "event" were censored at the last tumor assessment. Those who started subsequent anticancer therapy without a prior "event" were censored at the last tumor assessment prior to or upon starting subsequent therapy.\n\nBased on Kaplan-Meier Estimates.', 'unitOfMeasure': 'Percent of participants', 'dispersionType': '90% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'All treated participants in Cohort 1. Prespecified to be collected for Cohort 1 only.'}, {'type': 'PRIMARY', 'title': 'Complete Metabolic Response (CMR) Rate at Any Time Prior to High Dose Chemotherapy Followed by Autologous Stem Cell Treatment (HDCT/ASCT) by Blinded Independent Centralized Review (BICR) - Cohort 2', 'denoms': [{'units': 'Participants', 'counts': [{'value': '44', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Cohort 2: Relapsed/Refractory Classic Hodgkin Lymphoma - Standard Risk Relapse', 'description': 'Participants started in the induction phase and received nivolumab + brentuximab vedotin (N+Bv) for 2 cycles (6 weeks). Participants with radiographic progression, as assessed by Investigator at Cycle 2 entered follow-up. The rest of the participants received 2 additional cycles of N+Bv study therapy (total 4 cycles = 12 weeks).\n\n* Participants who had complete metabolic response (CMR), by BICR, after a total of 4 cycles (12 weeks) of N+Bv proceeded with high-dose chemotherapy followed by an autologous stem cell transplant (HDCT/ASCT) (consolidation phase). Participants with CMR had the option to receive up to 2 additional cycles of N+Bv if their HDCT/ASCT was postponed for any reason.\n* Participants without a CMR, by BICR, after 4 cycles of N+Bv received 2 cycles of brentuximab + bendamustine (Bv+B) (intensification phase).\n* Participants in CMR, by BICR, after 2 cycles of Bv+B received HDCT/ASCT (consolidation phase).\n* Participants without CMR by BICR could receive 2 additional cycles of Bv+B. If these participants attained CMR, they proceeded with HDCT/ASCT (consolidation phase).\n* Participants with CMR had the option to receive up to 2 additional cycles of B+Bv if their HDCT/ASCT was postponed.\n* Participants who had radiographic progression after Cycle 4 N+Bv, during study treatment or those who did not achieve CMR after final cycle of Bv+B were taken off study treatment and entered follow-up.'}], 'classes': [{'categories': [{'measurements': [{'value': '88.6', 'groupId': 'OG000', 'lowerLimit': '77.6', 'upperLimit': '95.4'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'From first dose to complete metabolic response or the completion of six cycles of therapy (up to approximately 18 weeks)', 'description': 'The complete metabolic response (CMR) rate is defined as the percent of all response-evaluable participants who, assessed by the BICR, achieved best response of CMR.\n\nComplete metabolic response (CMR):\n\n* Lymph nodes/extralymphatic sites: Score 1, 2, 3 with/without residual mass on 5-point scale\n* New lesions: No\n* Bone marrow: No FDG-avid disease Participants who came off study treatment early for toxicity without a CMR were evaluable.\n\nConfidence interval is based on the Clopper and Pearson method', 'unitOfMeasure': 'Percent of participants', 'dispersionType': '90% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'All treated participants in Cohort 2. Prespecified to be collected for Cohort 2 only.'}, {'type': 'SECONDARY', 'title': 'Overall Response Rate (ORR) Following 4 Cycles of Nivolumab + Brentuximab Vedotin Treatment by Blinded Independent Centralized Review (BICR)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '28', 'groupId': 'OG000'}, {'value': '44', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Cohort 1: Relapsed/Refractory Classic Hodgkin Lymphoma - Low Risk Relapse', 'description': 'Participants started in the induction phase and received nivolumab + brentuximab vedotin (N+Bv) for 2 cycles (6 weeks). Participants with radiographic progression, as assessed by Investigator at Cycle 2 entered follow-up. The rest of the participants continued in the induction phase and received 2 additional cycles of N+Bv study therapy (total 4 cycles = 12 weeks).\n\n* Participants who had a complete metabolic response (CMR) by BICR after a total of 4 cycles (12 weeks) of N+Bv received an additional 2 cycles of treatment of N+Bv (for a total of 6 cycles \\[18 weeks\\]), followed by Radiation Therapy (RT) (consolidation phase).\n* Participants without a CMR after 4 cycles of N+Bv, by BICR, entered the intensification phase and received 2 cycles of brentuximab + bendamustine (Bv+B); participants who achieved CMR after these 2 cycles proceeded with RT (consolidation phase).\n* Participants who had radiographic progression after Cycle 4 N+Bv, as assessed by BICR, or those who did not achieve CMR, by BICR, after 2 cycles of Bv+B were taken off study treatment and entered follow-up.'}, {'id': 'OG001', 'title': 'Cohort 2: Relapsed/Refractory Classic Hodgkin Lymphoma - Standard Risk Relapse', 'description': 'Participants started in the induction phase and received nivolumab + brentuximab vedotin (N+Bv) for 2 cycles (6 weeks). Participants with radiographic progression, as assessed by Investigator at Cycle 2 entered follow-up. The rest of the participants received 2 additional cycles of N+Bv study therapy (total 4 cycles = 12 weeks).\n\n* Participants who had complete metabolic response (CMR), by BICR, after a total of 4 cycles (12 weeks) of N+Bv proceeded with high-dose chemotherapy followed by an autologous stem cell transplant (HDCT/ASCT) (consolidation phase). Participants with CMR had the option to receive up to 2 additional cycles of N+Bv if their HDCT/ASCT was postponed for any reason.\n* Participants without a CMR, by BICR, after 4 cycles of N+Bv received 2 cycles of brentuximab + bendamustine (Bv+B) (intensification phase).\n* Participants in CMR, by BICR, after 2 cycles of Bv+B received HDCT/ASCT (consolidation phase).\n* Participants without CMR by BICR could receive 2 additional cycles of Bv+B. If these participants attained CMR, they proceeded with HDCT/ASCT (consolidation phase).\n* Participants with CMR had the option to receive up to 2 additional cycles of B+Bv if their HDCT/ASCT was postponed.\n* Participants who had radiographic progression after Cycle 4 N+Bv, during study treatment or those who did not achieve CMR after final cycle of Bv+B were taken off study treatment and entered follow-up.'}], 'classes': [{'categories': [{'measurements': [{'value': '96.4', 'groupId': 'OG000', 'lowerLimit': '84.1', 'upperLimit': '99.8'}, {'value': '93.2', 'groupId': 'OG001', 'lowerLimit': '83.3', 'upperLimit': '98.1'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'From first dose to PMR or CMR within 4 cycles of therapy, or the completion of four cycles of therapy (N+Bv x4) (up to approximately 12 weeks).', 'description': 'Overall response rate (ORR) is defined as the percent of all response-evaluable participants who, assessed by the BICR, achieved a best response of complete metabolic response (CMR) or partial metabolic response (PMR).\n\nComplete metabolic response (CMR):\n\n* Lymph nodes/extralymphatic sites: Score 1, 2, 3 with/without residual mass on 5-point scale\n* New lesions: No\n* Bone marrow: No FDG-avid disease\n\nPartial metabolic response (PMR):\n\n* Lymph nodes/extralymphatic: Score 4 or 5, reduced uptake from baseline\n* New lesions: None\n* Bone marrow: Residual uptake higher than normal, reduced from baseline. Participants who came off early for toxicity without CMR or PMR were evaluable.', 'unitOfMeasure': 'Percent of participants', 'dispersionType': '90% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'All treated participants.'}, {'type': 'SECONDARY', 'title': 'Progression Free Survival (PFS) Rate at 3 Years by Blinded Independent Centralized Review (BICR)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '28', 'groupId': 'OG000'}, {'value': '44', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Cohort 1: Relapsed/Refractory Classic Hodgkin Lymphoma - Low Risk Relapse', 'description': 'Participants started in the induction phase and received nivolumab + brentuximab vedotin (N+Bv) for 2 cycles (6 weeks). Participants with radiographic progression, as assessed by Investigator at Cycle 2 entered follow-up. The rest of the participants continued in the induction phase and received 2 additional cycles of N+Bv study therapy (total 4 cycles = 12 weeks).\n\n* Participants who had a complete metabolic response (CMR) by BICR after a total of 4 cycles (12 weeks) of N+Bv received an additional 2 cycles of treatment of N+Bv (for a total of 6 cycles \\[18 weeks\\]), followed by Radiation Therapy (RT) (consolidation phase).\n* Participants without a CMR after 4 cycles of N+Bv, by BICR, entered the intensification phase and received 2 cycles of brentuximab + bendamustine (Bv+B); participants who achieved CMR after these 2 cycles proceeded with RT (consolidation phase).\n* Participants who had radiographic progression after Cycle 4 N+Bv, as assessed by BICR, or those who did not achieve CMR, by BICR, after 2 cycles of Bv+B were taken off study treatment and entered follow-up.'}, {'id': 'OG001', 'title': 'Cohort 2: Relapsed/Refractory Classic Hodgkin Lymphoma - Standard Risk Relapse', 'description': 'Participants started in the induction phase and received nivolumab + brentuximab vedotin (N+Bv) for 2 cycles (6 weeks). Participants with radiographic progression, as assessed by Investigator at Cycle 2 entered follow-up. The rest of the participants received 2 additional cycles of N+Bv study therapy (total 4 cycles = 12 weeks).\n\n* Participants who had complete metabolic response (CMR), by BICR, after a total of 4 cycles (12 weeks) of N+Bv proceeded with high-dose chemotherapy followed by an autologous stem cell transplant (HDCT/ASCT) (consolidation phase). Participants with CMR had the option to receive up to 2 additional cycles of N+Bv if their HDCT/ASCT was postponed for any reason.\n* Participants without a CMR, by BICR, after 4 cycles of N+Bv received 2 cycles of brentuximab + bendamustine (Bv+B) (intensification phase).\n* Participants in CMR, by BICR, after 2 cycles of Bv+B received HDCT/ASCT (consolidation phase).\n* Participants without CMR by BICR could receive 2 additional cycles of Bv+B. If these participants attained CMR, they proceeded with HDCT/ASCT (consolidation phase).\n* Participants with CMR had the option to receive up to 2 additional cycles of B+Bv if their HDCT/ASCT was postponed.\n* Participants who had radiographic progression after Cycle 4 N+Bv, during study treatment or those who did not achieve CMR after final cycle of Bv+B were taken off study treatment and entered follow-up.'}], 'classes': [{'categories': [{'measurements': [{'value': '95.2', 'groupId': 'OG000', 'lowerLimit': '77.7', 'upperLimit': '99.1'}, {'value': '91.1', 'groupId': 'OG001', 'lowerLimit': '78.4', 'upperLimit': '96.5'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'At 3 years post first dose of study therapy', 'description': 'Progression Free Survival (PFS) is the time from the date of first treatment to the date of first documented disease progression by BICR or death.\n\nProgressive Disease (PD):\n\nLymph Nodes and Lesions: new growth or increase of \\>= 50% in size from nadir. New or growing lesions outside the lymph nodes.\n\nSpleen: Significant increase in spleen size, either from a previously enlarged state or from normal size.\n\nNew Lesions: Yes Bone Marrow: New or returning FDG-avid disease. Participants who neither progressed nor died were censored at the last adequate tumor assessment. Participants who started subsequent anticancer therapy (that is not part of high dose chemotherapy followed by autologous stem cell transplant (HDCT/ASCT) Consolidation Therapy for R2 Cohort) without a prior reported progression or death were censored at the last tumor assessment prior to initiation of the subsequent anticancer therapy.\n\nBased on Kaplan-Meier Estimates.', 'unitOfMeasure': 'Percent of participants', 'dispersionType': '90% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'All treated participants.'}, {'type': 'SECONDARY', 'title': 'Duration of Response (DOR) by Blinded Independent Centralized Review (BICR)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '28', 'groupId': 'OG000'}, {'value': '43', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Cohort 1: Relapsed/Refractory Classic Hodgkin Lymphoma - Low Risk Relapse', 'description': 'Participants started in the induction phase and received nivolumab + brentuximab vedotin (N+Bv) for 2 cycles (6 weeks). Participants with radiographic progression, as assessed by Investigator at Cycle 2 entered follow-up. The rest of the participants continued in the induction phase and received 2 additional cycles of N+Bv study therapy (total 4 cycles = 12 weeks).\n\n* Participants who had a complete metabolic response (CMR) by BICR after a total of 4 cycles (12 weeks) of N+Bv received an additional 2 cycles of treatment of N+Bv (for a total of 6 cycles \\[18 weeks\\]), followed by Radiation Therapy (RT) (consolidation phase).\n* Participants without a CMR after 4 cycles of N+Bv, by BICR, entered the intensification phase and received 2 cycles of brentuximab + bendamustine (Bv+B); participants who achieved CMR after these 2 cycles proceeded with RT (consolidation phase).\n* Participants who had radiographic progression after Cycle 4 N+Bv, as assessed by BICR, or those who did not achieve CMR, by BICR, after 2 cycles of Bv+B were taken off study treatment and entered follow-up.'}, {'id': 'OG001', 'title': 'Cohort 2: Relapsed/Refractory Classic Hodgkin Lymphoma - Standard Risk Relapse', 'description': 'Participants started in the induction phase and received nivolumab + brentuximab vedotin (N+Bv) for 2 cycles (6 weeks). Participants with radiographic progression, as assessed by Investigator at Cycle 2 entered follow-up. The rest of the participants received 2 additional cycles of N+Bv study therapy (total 4 cycles = 12 weeks).\n\n* Participants who had complete metabolic response (CMR), by BICR, after a total of 4 cycles (12 weeks) of N+Bv proceeded with high-dose chemotherapy followed by an autologous stem cell transplant (HDCT/ASCT) (consolidation phase). Participants with CMR had the option to receive up to 2 additional cycles of N+Bv if their HDCT/ASCT was postponed for any reason.\n* Participants without a CMR, by BICR, after 4 cycles of N+Bv received 2 cycles of brentuximab + bendamustine (Bv+B) (intensification phase).\n* Participants in CMR, by BICR, after 2 cycles of Bv+B received HDCT/ASCT (consolidation phase).\n* Participants without CMR by BICR could receive 2 additional cycles of Bv+B. If these participants attained CMR, they proceeded with HDCT/ASCT (consolidation phase).\n* Participants with CMR had the option to receive up to 2 additional cycles of B+Bv if their HDCT/ASCT was postponed.\n* Participants who had radiographic progression after Cycle 4 N+Bv, during study treatment or those who did not achieve CMR after final cycle of Bv+B were taken off study treatment and entered follow-up.'}], 'classes': [{'categories': [{'measurements': [{'value': 'NA', 'comment': 'Insufficient number of events to calculate median or confidence interval using Kaplan-Meier estimates.', 'groupId': 'OG000', 'lowerLimit': 'NA', 'upperLimit': 'NA'}, {'value': 'NA', 'comment': 'Insufficient number of events to calculate median or confidence interval using Kaplan-Meier estimates.', 'groupId': 'OG001', 'lowerLimit': 'NA', 'upperLimit': 'NA'}]}]}], 'paramType': 'MEDIAN', 'timeFrame': 'From first dose until disease progression, start of subsequent anti-cancer therapy, or or death due to any cause (up to approximately 86 months)', 'description': 'Duration of response (DOR) is the time from first complete metabolic response or partial metabolic response (CMR or PMR) to event free survival EFS (Cohort 1)/progression free survival PFS (Cohort 2) event. For participants with no event, DOR was censored on the date of last tumor assessment.\n\nParticipants who started subsequent anticancer therapy (not part of high-dose chemotherapy followed by autologous stem cell transplant HDCT/ASCT) without a prior reported EFS/PFS event were censored at the last tumor assessment prior to initiation of the subsequent therapy.\n\nComplete metabolic response (CMR):\n\n* Lymph nodes/extralymphatic sites: Score 1, 2, 3 with/without residual mass on 5-point scale\n* New lesions: No\n* Bone marrow: No FDG-avid disease\n\nPartial metabolic response (PMR):\n\n* Lymph nodes/extralymphatic: Score 4 or 5, reduced uptake from baseline\n* New lesions: None\n* Bone marrow: Residual uptake higher than normal, reduced from baseline. Based on Kaplan-Meier estimates', 'unitOfMeasure': 'Months', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'All treated participants with a response of complete metabolic response (CMR) or partial metabolic response (PMR).'}, {'type': 'SECONDARY', 'title': 'Complete Metabolic Response (CMR) Rate at Any Time Prior to Radiation Therapy by Investigator - Cohort 1', 'denoms': [{'units': 'Participants', 'counts': [{'value': '28', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Cohort 1: Relapsed/Refractory Classic Hodgkin Lymphoma - Low Risk Relapse', 'description': 'Participants started in the induction phase and received nivolumab + brentuximab vedotin (N+Bv) for 2 cycles (6 weeks). Participants with radiographic progression, as assessed by Investigator at Cycle 2 entered follow-up. The rest of the participants continued in the induction phase and received 2 additional cycles of N+Bv study therapy (total 4 cycles = 12 weeks).\n\n* Participants who had a complete metabolic response (CMR) by BICR after a total of 4 cycles (12 weeks) of N+Bv received an additional 2 cycles of treatment of N+Bv (for a total of 6 cycles \\[18 weeks\\]), followed by Radiation Therapy (RT) (consolidation phase).\n* Participants without a CMR after 4 cycles of N+Bv, by BICR, entered the intensification phase and received 2 cycles of brentuximab + bendamustine (Bv+B); participants who achieved CMR after these 2 cycles proceeded with RT (consolidation phase).\n* Participants who had radiographic progression after Cycle 4 N+Bv, as assessed by BICR, or those who did not achieve CMR, by BICR, after 2 cycles of Bv+B were taken off study treatment and entered follow-up.'}], 'classes': [{'categories': [{'measurements': [{'value': '89.3', 'groupId': 'OG000', 'lowerLimit': '74.6', 'upperLimit': '97.0'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'From first dose to complete metabolic response or the completion of six cycles of therapy (up to approximately 18 weeks).', 'description': 'The complete metabolic response (CMR) rate is defined as the percent of all response-evaluable participants who, assessed by the investigator, achieved best response of CMR.\n\nComplete metabolic response (CMR):\n\n* Lymph nodes/extralymphatic sites: Score 1, 2, 3 with/without residual mass on 5-point scale\n* New lesions: No\n* Bone marrow: No FDG-avid disease Participants who come off early for toxicity without a CMR were evaluable. Confidence interval is based on the Clopper and Pearson method', 'unitOfMeasure': 'Percent of participants', 'dispersionType': '90% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'All treated participants in Cohort 1. Prespecified to be collected for Cohort 1 only.'}, {'type': 'SECONDARY', 'title': 'Event-free Survival (EFS) Rate at 3 Years by Investigator - Cohort 1', 'denoms': [{'units': 'Participants', 'counts': [{'value': '28', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Cohort 1: Relapsed/Refractory Classic Hodgkin Lymphoma - Low Risk Relapse', 'description': 'Participants started in the induction phase and received nivolumab + brentuximab vedotin (N+Bv) for 2 cycles (6 weeks). Participants with radiographic progression, as assessed by Investigator at Cycle 2 entered follow-up. The rest of the participants continued in the induction phase and received 2 additional cycles of N+Bv study therapy (total 4 cycles = 12 weeks).\n\n* Participants who had a complete metabolic response (CMR) by BICR after a total of 4 cycles (12 weeks) of N+Bv received an additional 2 cycles of treatment of N+Bv (for a total of 6 cycles \\[18 weeks\\]), followed by Radiation Therapy (RT) (consolidation phase).\n* Participants without a CMR after 4 cycles of N+Bv, by BICR, entered the intensification phase and received 2 cycles of brentuximab + bendamustine (Bv+B); participants who achieved CMR after these 2 cycles proceeded with RT (consolidation phase).\n* Participants who had radiographic progression after Cycle 4 N+Bv, as assessed by BICR, or those who did not achieve CMR, by BICR, after 2 cycles of Bv+B were taken off study treatment and entered follow-up.'}], 'classes': [{'categories': [{'measurements': [{'value': '88.5', 'groupId': 'OG000', 'lowerLimit': '72.8', 'upperLimit': '95.4'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'At 3 years post first dose of study therapy', 'description': 'Event Free Survival (EFS) is the time from the first treatment to the earliest occurrence of composite events including: Disease progression (PD), Failure to achieve complete metabolic response (CMR) after 4 cycles of N+Bv and 2 cycles of Bv+B, Secondary malignancy, Death .\n\nPD :\n\nLymph Nodes and Lesions: new growth or increase of \\>= 50% in size from nadir. New or growing lesions outside the lymph nodes.\n\nSpleen: Significant increase in spleen size, either from a previously enlarged state or from normal size.\n\nNew Lesions: Yes Bone Marrow: New or returning FDG-avid disease\n\nCMR:\n\nLymph nodes/extralymphatic sites: Score 1, 2, 3 with/without residual mass on 5-point scale New lesions: No Bone marrow: No FDG-avid disease Participants without an "event" were censored at the last tumor assessment. Those who started subsequent anticancer therapy without a prior "event" were censored at the last tumor assessment prior to or upon starting subsequent therapy.\n\nBased on Kaplan-Meier Estimates.', 'unitOfMeasure': 'Percent of participants', 'dispersionType': '90% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'All treated participants in Cohort 1. Prespecified to be collected for Cohort 1 only.'}, {'type': 'SECONDARY', 'title': 'Complete Metabolic Response (CMR) Rate at Any Time Prior to High Dose Chemotherapy Followed by Autologous Stem Cell Treatment (HDCT/ASCT) by Investigator - Cohort 2', 'denoms': [{'units': 'Participants', 'counts': [{'value': '44', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Cohort 2: Relapsed/Refractory Classic Hodgkin Lymphoma - Standard Risk Relapse', 'description': 'Participants started in the induction phase and received nivolumab + brentuximab vedotin (N+Bv) for 2 cycles (6 weeks). Participants with radiographic progression, as assessed by Investigator at Cycle 2 entered follow-up. The rest of the participants received 2 additional cycles of N+Bv study therapy (total 4 cycles = 12 weeks).\n\n* Participants who had complete metabolic response (CMR), by BICR, after a total of 4 cycles (12 weeks) of N+Bv proceeded with high-dose chemotherapy followed by an autologous stem cell transplant (HDCT/ASCT) (consolidation phase). Participants with CMR had the option to receive up to 2 additional cycles of N+Bv if their HDCT/ASCT was postponed for any reason.\n* Participants without a CMR, by BICR, after 4 cycles of N+Bv received 2 cycles of brentuximab + bendamustine (Bv+B) (intensification phase).\n* Participants in CMR, by BICR, after 2 cycles of Bv+B received HDCT/ASCT (consolidation phase).\n* Participants without CMR by BICR could receive 2 additional cycles of Bv+B. If these participants attained CMR, they proceeded with HDCT/ASCT (consolidation phase).\n* Participants with CMR had the option to receive up to 2 additional cycles of B+Bv if their HDCT/ASCT was postponed.\n* Participants who had radiographic progression after Cycle 4 N+Bv, during study treatment or those who did not achieve CMR after final cycle of Bv+B were taken off study treatment and entered follow-up.'}], 'classes': [{'categories': [{'measurements': [{'value': '86.4', 'groupId': 'OG000', 'lowerLimit': '74.8', 'upperLimit': '93.9'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'From first dose to complete metabolic response or the completion of six cycles of therapy (up to approximately 18 weeks)', 'description': 'The complete metabolic response (CMR) rate is defined as the percent of all response-evaluable participants who, assessed by the investigator, achieved best response of CMR.\n\nComplete metabolic response (CMR):\n\n* Lymph nodes/extralymphatic sites: Score 1, 2, 3 with/without residual mass on 5-point scale\n* New lesions: No\n* Bone marrow: No FDG-avid disease Participants who came off study treatment early for toxicity without a CMR were evaluable.\n\nConfidence interval is based on the Clopper and Pearson method.', 'unitOfMeasure': 'Percent of participants', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'All treated participants in Cohort 2. Prespecified to be collected for Cohort 2 only.'}, {'type': 'SECONDARY', 'title': 'Overall Response Rate (ORR) Following 4 Cycles of Nivolumab + Brentuximab Vedotin Treatment by Investigator', 'denoms': [{'units': 'Participants', 'counts': [{'value': '28', 'groupId': 'OG000'}, {'value': '44', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Cohort 1: Relapsed/Refractory Classic Hodgkin Lymphoma - Low Risk Relapse', 'description': 'Participants started in the induction phase and received nivolumab + brentuximab vedotin (N+Bv) for 2 cycles (6 weeks). Participants with radiographic progression, as assessed by Investigator at Cycle 2 entered follow-up. The rest of the participants continued in the induction phase and received 2 additional cycles of N+Bv study therapy (total 4 cycles = 12 weeks).\n\n* Participants who had a complete metabolic response (CMR) by BICR after a total of 4 cycles (12 weeks) of N+Bv received an additional 2 cycles of treatment of N+Bv (for a total of 6 cycles \\[18 weeks\\]), followed by Radiation Therapy (RT) (consolidation phase).\n* Participants without a CMR after 4 cycles of N+Bv, by BICR, entered the intensification phase and received 2 cycles of brentuximab + bendamustine (Bv+B); participants who achieved CMR after these 2 cycles proceeded with RT (consolidation phase).\n* Participants who had radiographic progression after Cycle 4 N+Bv, as assessed by BICR, or those who did not achieve CMR, by BICR, after 2 cycles of Bv+B were taken off study treatment and entered follow-up.'}, {'id': 'OG001', 'title': 'Cohort 2: Relapsed/Refractory Classic Hodgkin Lymphoma - Standard Risk Relapse', 'description': 'Participants started in the induction phase and received nivolumab + brentuximab vedotin (N+Bv) for 2 cycles (6 weeks). Participants with radiographic progression, as assessed by Investigator at Cycle 2 entered follow-up. The rest of the participants received 2 additional cycles of N+Bv study therapy (total 4 cycles = 12 weeks).\n\n* Participants who had complete metabolic response (CMR), by BICR, after a total of 4 cycles (12 weeks) of N+Bv proceeded with high-dose chemotherapy followed by an autologous stem cell transplant (HDCT/ASCT) (consolidation phase). Participants with CMR had the option to receive up to 2 additional cycles of N+Bv if their HDCT/ASCT was postponed for any reason.\n* Participants without a CMR, by BICR, after 4 cycles of N+Bv received 2 cycles of brentuximab + bendamustine (Bv+B) (intensification phase).\n* Participants in CMR, by BICR, after 2 cycles of Bv+B received HDCT/ASCT (consolidation phase).\n* Participants without CMR by BICR could receive 2 additional cycles of Bv+B. If these participants attained CMR, they proceeded with HDCT/ASCT (consolidation phase).\n* Participants with CMR had the option to receive up to 2 additional cycles of B+Bv if their HDCT/ASCT was postponed.\n* Participants who had radiographic progression after Cycle 4 N+Bv, during study treatment or those who did not achieve CMR after final cycle of Bv+B were taken off study treatment and entered follow-up.'}], 'classes': [{'categories': [{'measurements': [{'value': '100.0', 'groupId': 'OG000', 'lowerLimit': '89.9', 'upperLimit': '100.0'}, {'value': '90.9', 'groupId': 'OG001', 'lowerLimit': '80.4', 'upperLimit': '96.8'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'From first dose to PMR or CMR within 4 cycles of therapy, or the completion of four cycles of therapy (N+Bv x4) (up to approximately 12 weeks).', 'description': 'Overall response rate (ORR) is defined as the percent of all response-evaluable participants who, assessed by the investigator, achieve a best response of complete metabolic response (CMR) or partial metabolic response (PMR).\n\nComplete metabolic response (CMR):\n\n* Lymph nodes/extralymphatic sites: Score 1, 2, 3 with/without residual mass on 5-point scale\n* New lesions: No\n* Bone marrow: No FDG-avid disease\n\nPartial metabolic response:\n\n* Lymph nodes/extralymphatic: Score 4 or 5, reduced uptake from baseline\n* New lesions: None\n* Bone marrow: Residual uptake higher than normal, reduced from baseline Participants who came off early for toxicity without CMR or PMR were evaluable.', 'unitOfMeasure': 'Percent of participants', 'dispersionType': '90% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'All treated participants.'}, {'type': 'SECONDARY', 'title': 'Progression Free Survival (PFS) Rate at 3 Years by Investigator', 'denoms': [{'units': 'Participants', 'counts': [{'value': '28', 'groupId': 'OG000'}, {'value': '44', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Cohort 1: Relapsed/Refractory Classic Hodgkin Lymphoma - Low Risk Relapse', 'description': 'Participants started in the induction phase and received nivolumab + brentuximab vedotin (N+Bv) for 2 cycles (6 weeks). Participants with radiographic progression, as assessed by Investigator at Cycle 2 entered follow-up. The rest of the participants continued in the induction phase and received 2 additional cycles of N+Bv study therapy (total 4 cycles = 12 weeks).\n\n* Participants who had a complete metabolic response (CMR) by BICR after a total of 4 cycles (12 weeks) of N+Bv received an additional 2 cycles of treatment of N+Bv (for a total of 6 cycles \\[18 weeks\\]), followed by Radiation Therapy (RT) (consolidation phase).\n* Participants without a CMR after 4 cycles of N+Bv, by BICR, entered the intensification phase and received 2 cycles of brentuximab + bendamustine (Bv+B); participants who achieved CMR after these 2 cycles proceeded with RT (consolidation phase).\n* Participants who had radiographic progression after Cycle 4 N+Bv, as assessed by BICR, or those who did not achieve CMR, by BICR, after 2 cycles of Bv+B were taken off study treatment and entered follow-up.'}, {'id': 'OG001', 'title': 'Cohort 2: Relapsed/Refractory Classic Hodgkin Lymphoma - Standard Risk Relapse', 'description': 'Participants started in the induction phase and received nivolumab + brentuximab vedotin (N+Bv) for 2 cycles (6 weeks). Participants with radiographic progression, as assessed by Investigator at Cycle 2 entered follow-up. The rest of the participants received 2 additional cycles of N+Bv study therapy (total 4 cycles = 12 weeks).\n\n* Participants who had complete metabolic response (CMR), by BICR, after a total of 4 cycles (12 weeks) of N+Bv proceeded with high-dose chemotherapy followed by an autologous stem cell transplant (HDCT/ASCT) (consolidation phase). Participants with CMR had the option to receive up to 2 additional cycles of N+Bv if their HDCT/ASCT was postponed for any reason.\n* Participants without a CMR, by BICR, after 4 cycles of N+Bv received 2 cycles of brentuximab + bendamustine (Bv+B) (intensification phase).\n* Participants in CMR, by BICR, after 2 cycles of Bv+B received HDCT/ASCT (consolidation phase).\n* Participants without CMR by BICR could receive 2 additional cycles of Bv+B. If these participants attained CMR, they proceeded with HDCT/ASCT (consolidation phase).\n* Participants with CMR had the option to receive up to 2 additional cycles of B+Bv if their HDCT/ASCT was postponed.\n* Participants who had radiographic progression after Cycle 4 N+Bv, during study treatment or those who did not achieve CMR after final cycle of Bv+B were taken off study treatment and entered follow-up.'}], 'classes': [{'categories': [{'measurements': [{'value': '95.8', 'groupId': 'OG000', 'lowerLimit': '80.2', 'upperLimit': '99.2'}, {'value': '88.1', 'groupId': 'OG001', 'lowerLimit': '74.8', 'upperLimit': '94.6'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'At 3 years post first dose', 'description': 'Progression Free Survival (PFS) is the time from the date of first treatment to the date of first documented disease progression by investigator or death.\n\nProgressive Disease (PD):\n\nLymph Nodes and Lesions: new growth or increase of \\>= 50% in size from nadir. New or growing lesions outside the lymph nodes.\n\nSpleen: Significant increase in spleen size, either from a previously enlarged state or from normal size.\n\nNew Lesions: Yes Bone Marrow: New or returning FDG-avid disease. Participants who neither progressed nor died were be censored at the last adequate tumor assessment. Participants who started subsequent anticancer therapy (that is not part of high dose chemotherapy followed by autologous stem cell transplant (HDCT/ASCT) Consolidation Therapy forR2 Cohort) without a prior reported progression or death were censored at the last tumor assessment prior to initiation of the subsequent anticancer therapy.\n\nBased on Kaplan-Meier Estimates.', 'unitOfMeasure': 'Percent of participants', 'dispersionType': '90% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'All treated participants.'}, {'type': 'SECONDARY', 'title': 'Duration of Response (DOR) by Investigator', 'denoms': [{'units': 'Participants', 'counts': [{'value': '28', 'groupId': 'OG000'}, {'value': '44', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Cohort 1: Relapsed/Refractory Classic Hodgkin Lymphoma - Low Risk Relapse', 'description': 'Participants started in the induction phase and received nivolumab + brentuximab vedotin (N+Bv) for 2 cycles (6 weeks). Participants with radiographic progression, as assessed by Investigator at Cycle 2 entered follow-up. The rest of the participants continued in the induction phase and received 2 additional cycles of N+Bv study therapy (total 4 cycles = 12 weeks).\n\n* Participants who had a complete metabolic response (CMR) by BICR after a total of 4 cycles (12 weeks) of N+Bv received an additional 2 cycles of treatment of N+Bv (for a total of 6 cycles \\[18 weeks\\]), followed by Radiation Therapy (RT) (consolidation phase).\n* Participants without a CMR after 4 cycles of N+Bv, by BICR, entered the intensification phase and received 2 cycles of brentuximab + bendamustine (Bv+B); participants who achieved CMR after these 2 cycles proceeded with RT (consolidation phase).\n* Participants who had radiographic progression after Cycle 4 N+Bv, as assessed by BICR, or those who did not achieve CMR, by BICR, after 2 cycles of Bv+B were taken off study treatment and entered follow-up.'}, {'id': 'OG001', 'title': 'Cohort 2: Relapsed/Refractory Classic Hodgkin Lymphoma - Standard Risk Relapse', 'description': 'Participants started in the induction phase and received nivolumab + brentuximab vedotin (N+Bv) for 2 cycles (6 weeks). Participants with radiographic progression, as assessed by Investigator at Cycle 2 entered follow-up. The rest of the participants received 2 additional cycles of N+Bv study therapy (total 4 cycles = 12 weeks).\n\n* Participants who had complete metabolic response (CMR), by BICR, after a total of 4 cycles (12 weeks) of N+Bv proceeded with high-dose chemotherapy followed by an autologous stem cell transplant (HDCT/ASCT) (consolidation phase). Participants with CMR had the option to receive up to 2 additional cycles of N+Bv if their HDCT/ASCT was postponed for any reason.\n* Participants without a CMR, by BICR, after 4 cycles of N+Bv received 2 cycles of brentuximab + bendamustine (Bv+B) (intensification phase).\n* Participants in CMR, by BICR, after 2 cycles of Bv+B received HDCT/ASCT (consolidation phase).\n* Participants without CMR by BICR could receive 2 additional cycles of Bv+B. If these participants attained CMR, they proceeded with HDCT/ASCT (consolidation phase).\n* Participants with CMR had the option to receive up to 2 additional cycles of B+Bv if their HDCT/ASCT was postponed.\n* Participants who had radiographic progression after Cycle 4 N+Bv, during study treatment or those who did not achieve CMR after final cycle of Bv+B were taken off study treatment and entered follow-up.'}], 'classes': [{'categories': [{'measurements': [{'value': 'NA', 'comment': 'Insufficient number of events to calculate median or confidence interval using Kaplan-Meier estimates.', 'groupId': 'OG000', 'lowerLimit': 'NA', 'upperLimit': 'NA'}, {'value': 'NA', 'comment': 'Insufficient number of events to calculate median or confidence interval using Kaplan-Meier estimates.', 'groupId': 'OG001', 'lowerLimit': 'NA', 'upperLimit': 'NA'}]}]}], 'paramType': 'MEDIAN', 'timeFrame': 'From first dose until disease progression, start of subsequent anti-cancer therapy, or or death due to any cause (up to approximately 86 months)', 'description': 'Duration of response (DOR) is the time from first complete metabolic response or partial metabolic response (CMR or PMR) to event free survival EFS (Cohort 1)/progression free survival PFS (Cohort 2) event. For participants with no event, the DOR was censored on the date of last tumor assessment.\n\nParticipants who started subsequent anticancer therapy (not part of high-dose chemotherapy followed by autologous stem cell transplant HDCT/ASCT) without a prior reported EFS/PFS event were censored at the last tumor assessment prior to initiation of the subsequent anticancer therapy.\n\nComplete metabolic response (CMR):\n\n* Lymph nodes/extralymphatic sites: Score 1, 2, 3 with/without residual mass on 5-point scale\n* New lesions: No\n* Bone marrow: No FDG-avid disease\n\nPartial metabolic response:\n\n* Lymph nodes/extralymphatic: Score 4 or 5, reduced uptake from baseline\n* New lesions: None\n* Bone marrow: Residual uptake higher than normal, reduced from baseline. Based on Kaplan-Meier estimates.', 'unitOfMeasure': 'Months', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'All treated participants with a response of complete metabolic response (CMR) or partial metabolic response (PMR).'}, {'type': 'SECONDARY', 'title': 'The Number of Participants With Adverse Events (AEs)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '28', 'groupId': 'OG000'}, {'value': '44', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Cohort 1: Relapsed/Refractory Classic Hodgkin Lymphoma - Low Risk Relapse', 'description': 'Participants started in the induction phase and received nivolumab + brentuximab vedotin (N+Bv) for 2 cycles (6 weeks). Participants with radiographic progression, as assessed by Investigator at Cycle 2 entered follow-up. The rest of the participants continued in the induction phase and received 2 additional cycles of N+Bv study therapy (total 4 cycles = 12 weeks).\n\n* Participants who had a complete metabolic response (CMR) by BICR after a total of 4 cycles (12 weeks) of N+Bv received an additional 2 cycles of treatment of N+Bv (for a total of 6 cycles \\[18 weeks\\]), followed by Radiation Therapy (RT) (consolidation phase).\n* Participants without a CMR after 4 cycles of N+Bv, by BICR, entered the intensification phase and received 2 cycles of brentuximab + bendamustine (Bv+B); participants who achieved CMR after these 2 cycles proceeded with RT (consolidation phase).\n* Participants who had radiographic progression after Cycle 4 N+Bv, as assessed by BICR, or those who did not achieve CMR, by BICR, after 2 cycles of Bv+B were taken off study treatment and entered follow-up.'}, {'id': 'OG001', 'title': 'Cohort 2: Relapsed/Refractory Classic Hodgkin Lymphoma - Standard Risk Relapse', 'description': 'Participants started in the induction phase and received nivolumab + brentuximab vedotin (N+Bv) for 2 cycles (6 weeks). Participants with radiographic progression, as assessed by Investigator at Cycle 2 entered follow-up. The rest of the participants received 2 additional cycles of N+Bv study therapy (total 4 cycles = 12 weeks).\n\n* Participants who had complete metabolic response (CMR), by BICR, after a total of 4 cycles (12 weeks) of N+Bv proceeded with high-dose chemotherapy followed by an autologous stem cell transplant (HDCT/ASCT) (consolidation phase). Participants with CMR had the option to receive up to 2 additional cycles of N+Bv if their HDCT/ASCT was postponed for any reason.\n* Participants without a CMR, by BICR, after 4 cycles of N+Bv received 2 cycles of brentuximab + bendamustine (Bv+B) (intensification phase).\n* Participants in CMR, by BICR, after 2 cycles of Bv+B received HDCT/ASCT (consolidation phase).\n* Participants without CMR by BICR could receive 2 additional cycles of Bv+B. If these participants attained CMR, they proceeded with HDCT/ASCT (consolidation phase).\n* Participants with CMR had the option to receive up to 2 additional cycles of B+Bv if their HDCT/ASCT was postponed.\n* Participants who had radiographic progression after Cycle 4 N+Bv, during study treatment or those who did not achieve CMR after final cycle of Bv+B were taken off study treatment and entered follow-up.'}], 'classes': [{'categories': [{'measurements': [{'value': '26', 'groupId': 'OG000'}, {'value': '42', 'groupId': 'OG001'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'From first dose to 30 days post last dose (an average of 4 months up until a maximum of 7 months).', 'description': 'An Adverse Event (AE) is defined as any new untoward medical occurrence or worsening of a preexisting medical condition in a clinical investigation participant administered study drug and that does not necessarily have a causal relationship with this treatment. An AE can therefore be any unfavorable and unintended sign (such as an abnormal laboratory finding), symptom, or disease temporally associated with the use of study drug, whether or not considered related to the study drug.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'All treated participants.'}, {'type': 'SECONDARY', 'title': 'The Number of Participants With Serious Adverse Events (SAEs)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '28', 'groupId': 'OG000'}, {'value': '44', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Cohort 1: Relapsed/Refractory Classic Hodgkin Lymphoma - Low Risk Relapse', 'description': 'Participants started in the induction phase and received nivolumab + brentuximab vedotin (N+Bv) for 2 cycles (6 weeks). Participants with radiographic progression, as assessed by Investigator at Cycle 2 entered follow-up. The rest of the participants continued in the induction phase and received 2 additional cycles of N+Bv study therapy (total 4 cycles = 12 weeks).\n\n* Participants who had a complete metabolic response (CMR) by BICR after a total of 4 cycles (12 weeks) of N+Bv received an additional 2 cycles of treatment of N+Bv (for a total of 6 cycles \\[18 weeks\\]), followed by Radiation Therapy (RT) (consolidation phase).\n* Participants without a CMR after 4 cycles of N+Bv, by BICR, entered the intensification phase and received 2 cycles of brentuximab + bendamustine (Bv+B); participants who achieved CMR after these 2 cycles proceeded with RT (consolidation phase).\n* Participants who had radiographic progression after Cycle 4 N+Bv, as assessed by BICR, or those who did not achieve CMR, by BICR, after 2 cycles of Bv+B were taken off study treatment and entered follow-up.'}, {'id': 'OG001', 'title': 'Cohort 2: Relapsed/Refractory Classic Hodgkin Lymphoma - Standard Risk Relapse', 'description': 'Participants started in the induction phase and received nivolumab + brentuximab vedotin (N+Bv) for 2 cycles (6 weeks). Participants with radiographic progression, as assessed by Investigator at Cycle 2 entered follow-up. The rest of the participants received 2 additional cycles of N+Bv study therapy (total 4 cycles = 12 weeks).\n\n* Participants who had complete metabolic response (CMR), by BICR, after a total of 4 cycles (12 weeks) of N+Bv proceeded with high-dose chemotherapy followed by an autologous stem cell transplant (HDCT/ASCT) (consolidation phase). Participants with CMR had the option to receive up to 2 additional cycles of N+Bv if their HDCT/ASCT was postponed for any reason.\n* Participants without a CMR, by BICR, after 4 cycles of N+Bv received 2 cycles of brentuximab + bendamustine (Bv+B) (intensification phase).\n* Participants in CMR, by BICR, after 2 cycles of Bv+B received HDCT/ASCT (consolidation phase).\n* Participants without CMR by BICR could receive 2 additional cycles of Bv+B. If these participants attained CMR, they proceeded with HDCT/ASCT (consolidation phase).\n* Participants with CMR had the option to receive up to 2 additional cycles of B+Bv if their HDCT/ASCT was postponed.\n* Participants who had radiographic progression after Cycle 4 N+Bv, during study treatment or those who did not achieve CMR after final cycle of Bv+B were taken off study treatment and entered follow-up.'}], 'classes': [{'categories': [{'measurements': [{'value': '8', 'groupId': 'OG000'}, {'value': '9', 'groupId': 'OG001'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'From first dose to 30 days post last dose (an average of 4 months up until a maximum of 7 months)', 'description': 'A Serious Adverse Event (SAE) is defined as any untoward medical occurrence that, at any dose:\n\n* Results in death\n* Is life-threatening (defined as an event in which the participant was at risk of death at the time of the event; it does not refer to an event which hypothetically might have caused death if it were more severe)\n* Requires inpatient hospitalization or causes prolongation of existing hospitalization\n* Results in persistent or significant disability/incapacity\n* Is a congenital anomaly/birth defect\n* Is an important medical event.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'All treated participants.'}, {'type': 'SECONDARY', 'title': 'The Number of Participants With Abnormal Laboratory Values for Specific Thyroid Tests', 'denoms': [{'units': 'Participants', 'counts': [{'value': '28', 'groupId': 'OG000'}, {'value': '44', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Cohort 1: Relapsed/Refractory Classic Hodgkin Lymphoma - Low Risk Relapse', 'description': 'Participants started in the induction phase and received nivolumab + brentuximab vedotin (N+Bv) for 2 cycles (6 weeks). Participants with radiographic progression, as assessed by Investigator at Cycle 2 entered follow-up. The rest of the participants continued in the induction phase and received 2 additional cycles of N+Bv study therapy (total 4 cycles = 12 weeks).\n\n* Participants who had a complete metabolic response (CMR) by BICR after a total of 4 cycles (12 weeks) of N+Bv received an additional 2 cycles of treatment of N+Bv (for a total of 6 cycles \\[18 weeks\\]), followed by Radiation Therapy (RT) (consolidation phase).\n* Participants without a CMR after 4 cycles of N+Bv, by BICR, entered the intensification phase and received 2 cycles of brentuximab + bendamustine (Bv+B); participants who achieved CMR after these 2 cycles proceeded with RT (consolidation phase).\n* Participants who had radiographic progression after Cycle 4 N+Bv, as assessed by BICR, or those who did not achieve CMR, by BICR, after 2 cycles of Bv+B were taken off study treatment and entered follow-up.'}, {'id': 'OG001', 'title': 'Cohort 2: Relapsed/Refractory Classic Hodgkin Lymphoma - Standard Risk Relapse', 'description': 'Participants started in the induction phase and received nivolumab + brentuximab vedotin (N+Bv) for 2 cycles (6 weeks). Participants with radiographic progression, as assessed by Investigator at Cycle 2 entered follow-up. The rest of the participants received 2 additional cycles of N+Bv study therapy (total 4 cycles = 12 weeks).\n\n* Participants who had complete metabolic response (CMR), by BICR, after a total of 4 cycles (12 weeks) of N+Bv proceeded with high-dose chemotherapy followed by an autologous stem cell transplant (HDCT/ASCT) (consolidation phase). Participants with CMR had the option to receive up to 2 additional cycles of N+Bv if their HDCT/ASCT was postponed for any reason.\n* Participants without a CMR, by BICR, after 4 cycles of N+Bv received 2 cycles of brentuximab + bendamustine (Bv+B) (intensification phase).\n* Participants in CMR, by BICR, after 2 cycles of Bv+B received HDCT/ASCT (consolidation phase).\n* Participants without CMR by BICR could receive 2 additional cycles of Bv+B. If these participants attained CMR, they proceeded with HDCT/ASCT (consolidation phase).\n* Participants with CMR had the option to receive up to 2 additional cycles of B+Bv if their HDCT/ASCT was postponed.\n* Participants who had radiographic progression after Cycle 4 N+Bv, during study treatment or those who did not achieve CMR after final cycle of Bv+B were taken off study treatment and entered follow-up.'}], 'classes': [{'title': 'TSH > ULN', 'categories': [{'measurements': [{'value': '6', 'groupId': 'OG000'}, {'value': '8', 'groupId': 'OG001'}]}]}, {'title': 'TSH > ULN WITH TSH <= ULN AT BASELINE', 'categories': [{'measurements': [{'value': '5', 'groupId': 'OG000'}, {'value': '4', 'groupId': 'OG001'}]}]}, {'title': 'TSH >ULN WITH ATLEAST ONE FT3/FT4 TEST VALUE <LLN', 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}, {'title': 'TSH >ULN WITH ALL OTHER FT3/FT4 TEST VALUES >= LLN', 'categories': [{'measurements': [{'value': '4', 'groupId': 'OG000'}, {'value': '5', 'groupId': 'OG001'}]}]}, {'title': 'TSH > ULN WITH FT3/FT4 TEST MISSING', 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}, {'value': '3', 'groupId': 'OG001'}]}]}, {'title': 'TSH < LLN', 'categories': [{'measurements': [{'value': '4', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}]}]}, {'title': 'TSH <LLN WITH TSH >= LLN AT BASELINE', 'categories': [{'measurements': [{'value': '4', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}]}]}, {'title': 'TSH <LLN WITH ATLEAST ONE FT3/FT4 TEST VALUE > ULN', 'categories': [{'measurements': [{'value': '3', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}]}]}, {'title': 'TSH <LLN WITH ALL OTHER FT3/FT4 TEST VALUES <= ULN', 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}, {'title': 'TSH < LLN WITH FT3/FT4 TEST MISSING', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'From first dose to 30 days post last dose (an average of 4 months up until a maximum of 7 months)', 'description': 'The Number of Participants with Abnormal Laboratory Values for Specific Thyroid Tests.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'All treated participants with at least one on treatment TSH measurement.'}, {'type': 'SECONDARY', 'title': 'The Number of Participants With Abnormal Laboratory Values for Liver Tests', 'denoms': [{'units': 'Participants', 'counts': [{'value': '28', 'groupId': 'OG000'}, {'value': '44', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Cohort 1: Relapsed/Refractory Classic Hodgkin Lymphoma - Low Risk Relapse', 'description': 'Participants started in the induction phase and received nivolumab + brentuximab vedotin (N+Bv) for 2 cycles (6 weeks). Participants with radiographic progression, as assessed by Investigator at Cycle 2 entered follow-up. The rest of the participants continued in the induction phase and received 2 additional cycles of N+Bv study therapy (total 4 cycles = 12 weeks).\n\n* Participants who had a complete metabolic response (CMR) by BICR after a total of 4 cycles (12 weeks) of N+Bv received an additional 2 cycles of treatment of N+Bv (for a total of 6 cycles \\[18 weeks\\]), followed by Radiation Therapy (RT) (consolidation phase).\n* Participants without a CMR after 4 cycles of N+Bv, by BICR, entered the intensification phase and received 2 cycles of brentuximab + bendamustine (Bv+B); participants who achieved CMR after these 2 cycles proceeded with RT (consolidation phase).\n* Participants who had radiographic progression after Cycle 4 N+Bv, as assessed by BICR, or those who did not achieve CMR, by BICR, after 2 cycles of Bv+B were taken off study treatment and entered follow-up.'}, {'id': 'OG001', 'title': 'Cohort 2: Relapsed/Refractory Classic Hodgkin Lymphoma - Standard Risk Relapse', 'description': 'Participants started in the induction phase and received nivolumab + brentuximab vedotin (N+Bv) for 2 cycles (6 weeks). Participants with radiographic progression, as assessed by Investigator at Cycle 2 entered follow-up. The rest of the participants received 2 additional cycles of N+Bv study therapy (total 4 cycles = 12 weeks).\n\n* Participants who had complete metabolic response (CMR), by BICR, after a total of 4 cycles (12 weeks) of N+Bv proceeded with high-dose chemotherapy followed by an autologous stem cell transplant (HDCT/ASCT) (consolidation phase). Participants with CMR had the option to receive up to 2 additional cycles of N+Bv if their HDCT/ASCT was postponed for any reason.\n* Participants without a CMR, by BICR, after 4 cycles of N+Bv received 2 cycles of brentuximab + bendamustine (Bv+B) (intensification phase).\n* Participants in CMR, by BICR, after 2 cycles of Bv+B received HDCT/ASCT (consolidation phase).\n* Participants without CMR by BICR could receive 2 additional cycles of Bv+B. If these participants attained CMR, they proceeded with HDCT/ASCT (consolidation phase).\n* Participants with CMR had the option to receive up to 2 additional cycles of B+Bv if their HDCT/ASCT was postponed.\n* Participants who had radiographic progression after Cycle 4 N+Bv, during study treatment or those who did not achieve CMR after final cycle of Bv+B were taken off study treatment and entered follow-up.'}], 'classes': [{'title': 'ALT OR AST > 3XULN', 'categories': [{'measurements': [{'value': '8', 'groupId': 'OG000'}, {'value': '5', 'groupId': 'OG001'}]}]}, {'title': 'ALT OR AST> 5XULN', 'categories': [{'measurements': [{'value': '3', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}]}]}, {'title': 'ALT OR AST> 10XULN', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}, {'title': 'ALT OR AST > 20XULN', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}, {'title': 'TOTAL BILIRUBIN > 2XULN', 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}, {'title': 'ALT/AST ELEV>3XULN;TOTAL BILIRUBIN>2XULN IN 1 DAY', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}, {'title': 'ALT/AST ELEV>3XULN;TOTAL BILIRUBIN>2XULN IN 30 DAYS', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'From first dose to 30 days post last dose (an average of 4 months up until a maximum of 7 months)', 'description': 'The Number of Participants with Abnormal Laboratory Values for Liver Tests.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'All treated participants with at least one on treatment measurement.'}, {'type': 'SECONDARY', 'title': 'Number of Participants With Abnormal Vital Signs Reported as Adverse Events', 'denoms': [{'units': 'Participants', 'counts': [{'value': '28', 'groupId': 'OG000'}, {'value': '44', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Cohort 1: Relapsed/Refractory Classic Hodgkin Lymphoma - Low Risk Relapse', 'description': 'Participants started in the induction phase and received nivolumab + brentuximab vedotin (N+Bv) for 2 cycles (6 weeks). Participants with radiographic progression, as assessed by Investigator at Cycle 2 entered follow-up. The rest of the participants continued in the induction phase and received 2 additional cycles of N+Bv study therapy (total 4 cycles = 12 weeks).\n\n* Participants who had a complete metabolic response (CMR) by BICR after a total of 4 cycles (12 weeks) of N+Bv received an additional 2 cycles of treatment of N+Bv (for a total of 6 cycles \\[18 weeks\\]), followed by Radiation Therapy (RT) (consolidation phase).\n* Participants without a CMR after 4 cycles of N+Bv, by BICR, entered the intensification phase and received 2 cycles of brentuximab + bendamustine (Bv+B); participants who achieved CMR after these 2 cycles proceeded with RT (consolidation phase).\n* Participants who had radiographic progression after Cycle 4 N+Bv, as assessed by BICR, or those who did not achieve CMR, by BICR, after 2 cycles of Bv+B were taken off study treatment and entered follow-up.'}, {'id': 'OG001', 'title': 'Cohort 2: Relapsed/Refractory Classic Hodgkin Lymphoma - Standard Risk Relapse', 'description': 'Participants started in the induction phase and received nivolumab + brentuximab vedotin (N+Bv) for 2 cycles (6 weeks). Participants with radiographic progression, as assessed by Investigator at Cycle 2 entered follow-up. The rest of the participants received 2 additional cycles of N+Bv study therapy (total 4 cycles = 12 weeks).\n\n* Participants who had complete metabolic response (CMR), by BICR, after a total of 4 cycles (12 weeks) of N+Bv proceeded with high-dose chemotherapy followed by an autologous stem cell transplant (HDCT/ASCT) (consolidation phase). Participants with CMR had the option to receive up to 2 additional cycles of N+Bv if their HDCT/ASCT was postponed for any reason.\n* Participants without a CMR, by BICR, after 4 cycles of N+Bv received 2 cycles of brentuximab + bendamustine (Bv+B) (intensification phase).\n* Participants in CMR, by BICR, after 2 cycles of Bv+B received HDCT/ASCT (consolidation phase).\n* Participants without CMR by BICR could receive 2 additional cycles of Bv+B. If these participants attained CMR, they proceeded with HDCT/ASCT (consolidation phase).\n* Participants with CMR had the option to receive up to 2 additional cycles of B+Bv if their HDCT/ASCT was postponed.\n* Participants who had radiographic progression after Cycle 4 N+Bv, during study treatment or those who did not achieve CMR after final cycle of Bv+B were taken off study treatment and entered follow-up.'}], 'classes': [{'title': 'Pyrexia', 'categories': [{'measurements': [{'value': '7', 'groupId': 'OG000'}, {'value': '23', 'groupId': 'OG001'}]}]}, {'title': 'Tachycardia', 'categories': [{'measurements': [{'value': '2', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}]}]}, {'title': 'Sinus Bradycardia', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '2', 'groupId': 'OG001'}]}]}, {'title': 'Hypertension', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '4', 'groupId': 'OG001'}]}]}, {'title': 'Hypotension', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '6', 'groupId': 'OG001'}]}]}, {'title': 'Orthostatic hypotension', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'From first dose to 100 days after last dose of study therapy (assessed for an average of 7 months up until a maximum of 10 months).', 'description': 'Temperature, blood pressure, and heart rate abnormalities reported as adverse events.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'All treated participants.'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Cohort 1: Relapsed/Refractory Classic Hodgkin Lymphoma - Low Risk Relapse', 'description': 'Participants started in the induction phase and received nivolumab + brentuximab vedotin (N+Bv) for 2 cycles (6 weeks). Participants with radiographic progression, as assessed by Investigator at Cycle 2 entered follow-up. The rest of the participants continued in the induction phase and received 2 additional cycles of N+Bv study therapy (total 4 cycles = 12 weeks).\n\n* Participants who had a complete metabolic response (CMR) by BICR after a total of 4 cycles (12 weeks) of N+Bv received an additional 2 cycles of treatment of N+Bv (for a total of 6 cycles \\[18 weeks\\]), followed by Radiation Therapy (RT) (consolidation phase).\n* Participants without a CMR after 4 cycles of N+Bv, by BICR, entered the intensification phase and received 2 cycles of brentuximab + bendamustine (Bv+B); participants who achieved CMR after these 2 cycles proceeded with RT (consolidation phase).\n* Participants who had radiographic progression after Cycle 4 N+Bv, as assessed by BICR, or those who did not achieve CMR, by BICR, after 2 cycles of Bv+B were taken off study treatment and entered follow-up.'}, {'id': 'FG001', 'title': 'Cohort 2: Relapsed/Refractory Classic Hodgkin Lymphoma - Standard Risk Relapse', 'description': 'Participants started in the induction phase and received nivolumab + brentuximab vedotin (N+Bv) for 2 cycles (6 weeks). Participants with radiographic progression, as assessed by Investigator at Cycle 2 entered follow-up. The rest of the participants received 2 additional cycles of N+Bv study therapy (total 4 cycles = 12 weeks).\n\n* Participants who had complete metabolic response (CMR), by BICR, after a total of 4 cycles (12 weeks) of N+Bv proceeded with high-dose chemotherapy followed by an autologous stem cell transplant (HDCT/ASCT) (consolidation phase). Participants with CMR had the option to receive up to 2 additional cycles of N+Bv if their HDCT/ASCT was postponed for any reason.\n* Participants without a CMR, by BICR, after 4 cycles of N+Bv received 2 cycles of brentuximab + bendamustine (Bv+B) (intensification phase).\n* Participants in CMR, by BICR, after 2 cycles of Bv+B received HDCT/ASCT (consolidation phase).\n* Participants without CMR by BICR could receive 2 additional cycles of Bv+B. If these participants attained CMR, they proceeded with HDCT/ASCT (consolidation phase).\n* Participants with CMR had the option to receive up to 2 additional cycles of B+Bv if their HDCT/ASCT was postponed.\n* Participants who had radiographic progression after Cycle 4 N+Bv, during study treatment or those who did not achieve CMR after final cycle of Bv+B were taken off study treatment and entered follow-up.'}], 'periods': [{'title': 'Induction Phase', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '28'}, {'groupId': 'FG001', 'numSubjects': '44'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '27'}, {'groupId': 'FG001', 'numSubjects': '42'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '2'}]}], 'dropWithdraws': [{'type': 'Study drug toxicity', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '1'}]}, {'type': 'Disease progression', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '1'}]}]}, {'title': 'Consolidation Phase', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '22'}, {'groupId': 'FG001', 'numSubjects': '32'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '22'}, {'groupId': 'FG001', 'numSubjects': '32'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}]}]}, {'title': 'Intensification Phase', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '6'}, {'groupId': 'FG001', 'numSubjects': '11'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '5'}, {'groupId': 'FG001', 'numSubjects': '11'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '0'}]}], 'dropWithdraws': [{'type': 'Study drug toxicity', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '0'}]}]}], 'preAssignmentDetails': 'All participants entered the Induction phase and received treatment with nivolumab + brentuximab vedotin (N+ Bv) Participants moved into the Intensification phase if they received treatment with brentuximab + bendamustine (Bv + B).\n\nParticipants moved into the Consolidation Phase if they received radiation therapy (Cohort 1) or high-dose chemotherapy followed by an autologous stem cell transplant (HDCT/ASCT) (Cohort 2).'}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '28', 'groupId': 'BG000'}, {'value': '44', 'groupId': 'BG001'}, {'value': '72', 'groupId': 'BG002'}]}], 'groups': [{'id': 'BG000', 'title': 'Cohort 1: Relapsed/Refractory Classic Hodgkin Lymphoma - Low Risk Relapse', 'description': 'Participants started in the induction phase and received nivolumab + brentuximab vedotin (N+Bv) for 2 cycles (6 weeks). Participants with radiographic progression, as assessed by Investigator at Cycle 2 entered follow-up. The rest of the participants continued in the induction phase and received 2 additional cycles of N+Bv study therapy (total 4 cycles = 12 weeks).\n\n* Participants who had a complete metabolic response (CMR) by BICR after a total of 4 cycles (12 weeks) of N+Bv received an additional 2 cycles of treatment of N+Bv (for a total of 6 cycles \\[18 weeks\\]), followed by Radiation Therapy (RT) (consolidation phase).\n* Participants without a CMR after 4 cycles of N+Bv, by BICR, entered the intensification phase and received 2 cycles of brentuximab + bendamustine (Bv+B); participants who achieved CMR after these 2 cycles proceeded with RT (consolidation phase).\n* Participants who had radiographic progression after Cycle 4 N+Bv, as assessed by BICR, or those who did not achieve CMR, by BICR, after 2 cycles of Bv+B were taken off study treatment and entered follow-up.'}, {'id': 'BG001', 'title': 'Cohort 2: Relapsed/Refractory Classic Hodgkin Lymphoma - Standard Risk Relapse', 'description': 'Participants started in the induction phase and received nivolumab + brentuximab vedotin (N+Bv) for 2 cycles (6 weeks). Participants with radiographic progression, as assessed by Investigator at Cycle 2 entered follow-up. The rest of the participants received 2 additional cycles of N+Bv study therapy (total 4 cycles = 12 weeks).\n\n* Participants who had complete metabolic response (CMR), by BICR, after a total of 4 cycles (12 weeks) of N+Bv proceeded with high-dose chemotherapy followed by an autologous stem cell transplant (HDCT/ASCT) (consolidation phase). Participants with CMR had the option to receive up to 2 additional cycles of N+Bv if their HDCT/ASCT was postponed for any reason.\n* Participants without a CMR, by BICR, after 4 cycles of N+Bv received 2 cycles of brentuximab + bendamustine (Bv+B) (intensification phase).\n* Participants in CMR, by BICR, after 2 cycles of Bv+B received HDCT/ASCT (consolidation phase).\n* Participants without CMR by BICR could receive 2 additional cycles of Bv+B. If these participants attained CMR, they proceeded with HDCT/ASCT (consolidation phase).\n* Participants with CMR had the option to receive up to 2 additional cycles of B+Bv if their HDCT/ASCT was postponed.\n* Participants who had radiographic progression after Cycle 4 N+Bv, during study treatment or those who did not achieve CMR after final cycle of Bv+B were taken off study treatment and entered follow-up.'}, {'id': 'BG002', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Continuous', 'classes': [{'categories': [{'measurements': [{'value': '17.0', 'spread': '4.3', 'groupId': 'BG000'}, {'value': '16.2', 'spread': '3.7', 'groupId': 'BG001'}, {'value': '16.5', 'spread': '4', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'Years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '18', 'groupId': 'BG000'}, {'value': '15', 'groupId': 'BG001'}, {'value': '33', 'groupId': 'BG002'}]}, {'title': 'Male', 'measurements': [{'value': '10', 'groupId': 'BG000'}, {'value': '29', 'groupId': 'BG001'}, {'value': '39', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Ethnicity (NIH/OMB)', 'classes': [{'categories': [{'title': 'Hispanic or Latino', 'measurements': [{'value': '3', 'groupId': 'BG000'}, {'value': '1', 'groupId': 'BG001'}, {'value': '4', 'groupId': 'BG002'}]}, {'title': 'Not Hispanic or Latino', 'measurements': [{'value': '8', 'groupId': 'BG000'}, {'value': '20', 'groupId': 'BG001'}, {'value': '28', 'groupId': 'BG002'}]}, {'title': 'Unknown or Not Reported', 'measurements': [{'value': '17', 'groupId': 'BG000'}, {'value': '23', 'groupId': 'BG001'}, {'value': '40', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Race (NIH/OMB)', 'classes': [{'categories': [{'title': 'American Indian or Alaska Native', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}, {'title': 'Asian', 'measurements': [{'value': '1', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '1', 'groupId': 'BG002'}]}, {'title': 'Native Hawaiian or Other Pacific Islander', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '1', 'groupId': 'BG001'}, {'value': '1', 'groupId': 'BG002'}]}, {'title': 'Black or African American', 'measurements': [{'value': '1', 'groupId': 'BG000'}, {'value': '1', 'groupId': 'BG001'}, {'value': '2', 'groupId': 'BG002'}]}, {'title': 'White', 'measurements': [{'value': '25', 'groupId': 'BG000'}, {'value': '41', 'groupId': 'BG001'}, {'value': '66', 'groupId': 'BG002'}]}, {'title': 'More than one race', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}, {'title': 'Unknown or Not Reported', 'measurements': [{'value': '1', 'groupId': 'BG000'}, {'value': '1', 'groupId': 'BG001'}, {'value': '2', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}]}}, 'documentSection': {'largeDocumentModule': {'largeDocs': [{'date': '2021-03-26', 'size': 24136098, 'label': 'Study Protocol and Statistical Analysis Plan', 'hasIcf': False, 'hasSap': True, 'filename': 'Prot_SAP_000.pdf', 'typeAbbrev': 'Prot_SAP', 'uploadDate': '2024-11-01T09:14', 'hasProtocol': True}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NON_RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 72}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2017-03-28', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'nctId': 'NCT02475382', 'statusForNctId': 'NO_LONGER_AVAILABLE', 'hasExpandedAccess': True}, 'statusVerifiedDate': '2025-01', 'completionDateStruct': {'date': '2024-05-28', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2025-01-16', 'studyFirstSubmitDate': '2016-10-06', 'resultsFirstSubmitDate': '2024-11-01', 'studyFirstSubmitQcDate': '2016-10-06', 'lastUpdatePostDateStruct': {'date': '2025-02-10', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2025-01-16', 'studyFirstPostDateStruct': {'date': '2016-10-07', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2025-02-10', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2024-05-28', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Complete Metabolic Response (CMR) Rate at Any Time Prior to Radiation Therapy by Blinded Independent Centralized Review (BICR) - Cohort 1', 'timeFrame': 'From first dose to complete metabolic response or the completion of six cycles of therapy (up to approximately 18 weeks).', 'description': 'The complete metabolic response (CMR) rate is defined as the percent of all response-evaluable participants who, assessed by the BICR, achieved best response of CMR.\n\nComplete metabolic response (CMR):\n\n* Lymph nodes/extralymphatic sites: Score 1, 2, 3 with/without residual mass on 5-point scale\n* New lesions: No\n* Bone marrow: No FDG-avid disease Participants who stopped study treatment early for toxicity without a CMR were evaluable.\n\nConfidence interval is based on the Clopper and Pearson method'}, {'measure': 'Event-free Survival (EFS) Rate at 3 Years by Blinded Independent Centralized Review (BICR) - Cohort 1', 'timeFrame': 'At 3 years post first dose of study therapy', 'description': 'Event Free Survival (EFS) is the time from the first treatment to the earliest occurrence of composite events including: Disease progression (PD), Failure to achieve complete metabolic response (CMR) after 4 cycles of N+Bv and 2 cycles of Bv+B, Secondary malignancy, Death .\n\nPD :\n\nLymph Nodes and Lesions: new growth or increase of \\>= 50% in size from nadir. New or growing lesions outside the lymph nodes.\n\nSpleen: Significant increase in spleen size, either from a previously enlarged state or from normal size.\n\nNew Lesions: Yes Bone Marrow: New or returning FDG-avid disease\n\nCMR:\n\nLymph nodes/extralymphatic sites: Score 1, 2, 3 with/without residual mass on 5-point scale New lesions: No Bone marrow: No FDG-avid disease Participants without an "event" were censored at the last tumor assessment. Those who started subsequent anticancer therapy without a prior "event" were censored at the last tumor assessment prior to or upon starting subsequent therapy.\n\nBased on Kaplan-Meier Estimates.'}, {'measure': 'Complete Metabolic Response (CMR) Rate at Any Time Prior to High Dose Chemotherapy Followed by Autologous Stem Cell Treatment (HDCT/ASCT) by Blinded Independent Centralized Review (BICR) - Cohort 2', 'timeFrame': 'From first dose to complete metabolic response or the completion of six cycles of therapy (up to approximately 18 weeks)', 'description': 'The complete metabolic response (CMR) rate is defined as the percent of all response-evaluable participants who, assessed by the BICR, achieved best response of CMR.\n\nComplete metabolic response (CMR):\n\n* Lymph nodes/extralymphatic sites: Score 1, 2, 3 with/without residual mass on 5-point scale\n* New lesions: No\n* Bone marrow: No FDG-avid disease Participants who came off study treatment early for toxicity without a CMR were evaluable.\n\nConfidence interval is based on the Clopper and Pearson method'}], 'secondaryOutcomes': [{'measure': 'Overall Response Rate (ORR) Following 4 Cycles of Nivolumab + Brentuximab Vedotin Treatment by Blinded Independent Centralized Review (BICR)', 'timeFrame': 'From first dose to PMR or CMR within 4 cycles of therapy, or the completion of four cycles of therapy (N+Bv x4) (up to approximately 12 weeks).', 'description': 'Overall response rate (ORR) is defined as the percent of all response-evaluable participants who, assessed by the BICR, achieved a best response of complete metabolic response (CMR) or partial metabolic response (PMR).\n\nComplete metabolic response (CMR):\n\n* Lymph nodes/extralymphatic sites: Score 1, 2, 3 with/without residual mass on 5-point scale\n* New lesions: No\n* Bone marrow: No FDG-avid disease\n\nPartial metabolic response (PMR):\n\n* Lymph nodes/extralymphatic: Score 4 or 5, reduced uptake from baseline\n* New lesions: None\n* Bone marrow: Residual uptake higher than normal, reduced from baseline. Participants who came off early for toxicity without CMR or PMR were evaluable.'}, {'measure': 'Progression Free Survival (PFS) Rate at 3 Years by Blinded Independent Centralized Review (BICR)', 'timeFrame': 'At 3 years post first dose of study therapy', 'description': 'Progression Free Survival (PFS) is the time from the date of first treatment to the date of first documented disease progression by BICR or death.\n\nProgressive Disease (PD):\n\nLymph Nodes and Lesions: new growth or increase of \\>= 50% in size from nadir. New or growing lesions outside the lymph nodes.\n\nSpleen: Significant increase in spleen size, either from a previously enlarged state or from normal size.\n\nNew Lesions: Yes Bone Marrow: New or returning FDG-avid disease. Participants who neither progressed nor died were censored at the last adequate tumor assessment. Participants who started subsequent anticancer therapy (that is not part of high dose chemotherapy followed by autologous stem cell transplant (HDCT/ASCT) Consolidation Therapy for R2 Cohort) without a prior reported progression or death were censored at the last tumor assessment prior to initiation of the subsequent anticancer therapy.\n\nBased on Kaplan-Meier Estimates.'}, {'measure': 'Duration of Response (DOR) by Blinded Independent Centralized Review (BICR)', 'timeFrame': 'From first dose until disease progression, start of subsequent anti-cancer therapy, or or death due to any cause (up to approximately 86 months)', 'description': 'Duration of response (DOR) is the time from first complete metabolic response or partial metabolic response (CMR or PMR) to event free survival EFS (Cohort 1)/progression free survival PFS (Cohort 2) event. For participants with no event, DOR was censored on the date of last tumor assessment.\n\nParticipants who started subsequent anticancer therapy (not part of high-dose chemotherapy followed by autologous stem cell transplant HDCT/ASCT) without a prior reported EFS/PFS event were censored at the last tumor assessment prior to initiation of the subsequent therapy.\n\nComplete metabolic response (CMR):\n\n* Lymph nodes/extralymphatic sites: Score 1, 2, 3 with/without residual mass on 5-point scale\n* New lesions: No\n* Bone marrow: No FDG-avid disease\n\nPartial metabolic response (PMR):\n\n* Lymph nodes/extralymphatic: Score 4 or 5, reduced uptake from baseline\n* New lesions: None\n* Bone marrow: Residual uptake higher than normal, reduced from baseline. Based on Kaplan-Meier estimates'}, {'measure': 'Complete Metabolic Response (CMR) Rate at Any Time Prior to Radiation Therapy by Investigator - Cohort 1', 'timeFrame': 'From first dose to complete metabolic response or the completion of six cycles of therapy (up to approximately 18 weeks).', 'description': 'The complete metabolic response (CMR) rate is defined as the percent of all response-evaluable participants who, assessed by the investigator, achieved best response of CMR.\n\nComplete metabolic response (CMR):\n\n* Lymph nodes/extralymphatic sites: Score 1, 2, 3 with/without residual mass on 5-point scale\n* New lesions: No\n* Bone marrow: No FDG-avid disease Participants who come off early for toxicity without a CMR were evaluable. Confidence interval is based on the Clopper and Pearson method'}, {'measure': 'Event-free Survival (EFS) Rate at 3 Years by Investigator - Cohort 1', 'timeFrame': 'At 3 years post first dose of study therapy', 'description': 'Event Free Survival (EFS) is the time from the first treatment to the earliest occurrence of composite events including: Disease progression (PD), Failure to achieve complete metabolic response (CMR) after 4 cycles of N+Bv and 2 cycles of Bv+B, Secondary malignancy, Death .\n\nPD :\n\nLymph Nodes and Lesions: new growth or increase of \\>= 50% in size from nadir. New or growing lesions outside the lymph nodes.\n\nSpleen: Significant increase in spleen size, either from a previously enlarged state or from normal size.\n\nNew Lesions: Yes Bone Marrow: New or returning FDG-avid disease\n\nCMR:\n\nLymph nodes/extralymphatic sites: Score 1, 2, 3 with/without residual mass on 5-point scale New lesions: No Bone marrow: No FDG-avid disease Participants without an "event" were censored at the last tumor assessment. Those who started subsequent anticancer therapy without a prior "event" were censored at the last tumor assessment prior to or upon starting subsequent therapy.\n\nBased on Kaplan-Meier Estimates.'}, {'measure': 'Complete Metabolic Response (CMR) Rate at Any Time Prior to High Dose Chemotherapy Followed by Autologous Stem Cell Treatment (HDCT/ASCT) by Investigator - Cohort 2', 'timeFrame': 'From first dose to complete metabolic response or the completion of six cycles of therapy (up to approximately 18 weeks)', 'description': 'The complete metabolic response (CMR) rate is defined as the percent of all response-evaluable participants who, assessed by the investigator, achieved best response of CMR.\n\nComplete metabolic response (CMR):\n\n* Lymph nodes/extralymphatic sites: Score 1, 2, 3 with/without residual mass on 5-point scale\n* New lesions: No\n* Bone marrow: No FDG-avid disease Participants who came off study treatment early for toxicity without a CMR were evaluable.\n\nConfidence interval is based on the Clopper and Pearson method.'}, {'measure': 'Overall Response Rate (ORR) Following 4 Cycles of Nivolumab + Brentuximab Vedotin Treatment by Investigator', 'timeFrame': 'From first dose to PMR or CMR within 4 cycles of therapy, or the completion of four cycles of therapy (N+Bv x4) (up to approximately 12 weeks).', 'description': 'Overall response rate (ORR) is defined as the percent of all response-evaluable participants who, assessed by the investigator, achieve a best response of complete metabolic response (CMR) or partial metabolic response (PMR).\n\nComplete metabolic response (CMR):\n\n* Lymph nodes/extralymphatic sites: Score 1, 2, 3 with/without residual mass on 5-point scale\n* New lesions: No\n* Bone marrow: No FDG-avid disease\n\nPartial metabolic response:\n\n* Lymph nodes/extralymphatic: Score 4 or 5, reduced uptake from baseline\n* New lesions: None\n* Bone marrow: Residual uptake higher than normal, reduced from baseline Participants who came off early for toxicity without CMR or PMR were evaluable.'}, {'measure': 'Progression Free Survival (PFS) Rate at 3 Years by Investigator', 'timeFrame': 'At 3 years post first dose', 'description': 'Progression Free Survival (PFS) is the time from the date of first treatment to the date of first documented disease progression by investigator or death.\n\nProgressive Disease (PD):\n\nLymph Nodes and Lesions: new growth or increase of \\>= 50% in size from nadir. New or growing lesions outside the lymph nodes.\n\nSpleen: Significant increase in spleen size, either from a previously enlarged state or from normal size.\n\nNew Lesions: Yes Bone Marrow: New or returning FDG-avid disease. Participants who neither progressed nor died were be censored at the last adequate tumor assessment. Participants who started subsequent anticancer therapy (that is not part of high dose chemotherapy followed by autologous stem cell transplant (HDCT/ASCT) Consolidation Therapy forR2 Cohort) without a prior reported progression or death were censored at the last tumor assessment prior to initiation of the subsequent anticancer therapy.\n\nBased on Kaplan-Meier Estimates.'}, {'measure': 'Duration of Response (DOR) by Investigator', 'timeFrame': 'From first dose until disease progression, start of subsequent anti-cancer therapy, or or death due to any cause (up to approximately 86 months)', 'description': 'Duration of response (DOR) is the time from first complete metabolic response or partial metabolic response (CMR or PMR) to event free survival EFS (Cohort 1)/progression free survival PFS (Cohort 2) event. For participants with no event, the DOR was censored on the date of last tumor assessment.\n\nParticipants who started subsequent anticancer therapy (not part of high-dose chemotherapy followed by autologous stem cell transplant HDCT/ASCT) without a prior reported EFS/PFS event were censored at the last tumor assessment prior to initiation of the subsequent anticancer therapy.\n\nComplete metabolic response (CMR):\n\n* Lymph nodes/extralymphatic sites: Score 1, 2, 3 with/without residual mass on 5-point scale\n* New lesions: No\n* Bone marrow: No FDG-avid disease\n\nPartial metabolic response:\n\n* Lymph nodes/extralymphatic: Score 4 or 5, reduced uptake from baseline\n* New lesions: None\n* Bone marrow: Residual uptake higher than normal, reduced from baseline. Based on Kaplan-Meier estimates.'}, {'measure': 'The Number of Participants With Adverse Events (AEs)', 'timeFrame': 'From first dose to 30 days post last dose (an average of 4 months up until a maximum of 7 months).', 'description': 'An Adverse Event (AE) is defined as any new untoward medical occurrence or worsening of a preexisting medical condition in a clinical investigation participant administered study drug and that does not necessarily have a causal relationship with this treatment. An AE can therefore be any unfavorable and unintended sign (such as an abnormal laboratory finding), symptom, or disease temporally associated with the use of study drug, whether or not considered related to the study drug.'}, {'measure': 'The Number of Participants With Serious Adverse Events (SAEs)', 'timeFrame': 'From first dose to 30 days post last dose (an average of 4 months up until a maximum of 7 months)', 'description': 'A Serious Adverse Event (SAE) is defined as any untoward medical occurrence that, at any dose:\n\n* Results in death\n* Is life-threatening (defined as an event in which the participant was at risk of death at the time of the event; it does not refer to an event which hypothetically might have caused death if it were more severe)\n* Requires inpatient hospitalization or causes prolongation of existing hospitalization\n* Results in persistent or significant disability/incapacity\n* Is a congenital anomaly/birth defect\n* Is an important medical event.'}, {'measure': 'The Number of Participants With Abnormal Laboratory Values for Specific Thyroid Tests', 'timeFrame': 'From first dose to 30 days post last dose (an average of 4 months up until a maximum of 7 months)', 'description': 'The Number of Participants with Abnormal Laboratory Values for Specific Thyroid Tests.'}, {'measure': 'The Number of Participants With Abnormal Laboratory Values for Liver Tests', 'timeFrame': 'From first dose to 30 days post last dose (an average of 4 months up until a maximum of 7 months)', 'description': 'The Number of Participants with Abnormal Laboratory Values for Liver Tests.'}, {'measure': 'Number of Participants With Abnormal Vital Signs Reported as Adverse Events', 'timeFrame': 'From first dose to 100 days after last dose of study therapy (assessed for an average of 7 months up until a maximum of 10 months).', 'description': 'Temperature, blood pressure, and heart rate abnormalities reported as adverse events.'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': True, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Hodgkin Disease']}, 'referencesModule': {'references': [{'pmid': '39745739', 'type': 'DERIVED', 'citation': 'Daw S, Cole PD, Hoppe BS, Hodgson D, Beishuizen A, Garnier N, Buffardi S, Mascarin M, Lissat A, Mauz-Korholz C, Krajewski J, Akyol A, Crowe R, Anderson B, Xu Y, Drachtman RA, Kelly KM, Leblanc T, Harker-Murray P. Transplant-Free Approach in Relapsed Hodgkin Lymphoma in Children, Adolescents, and Young Adults: A Nonrandomized Clinical Trial. JAMA Oncol. 2025 Mar 1;11(3):249-257. doi: 10.1001/jamaoncol.2024.5627.'}, {'pmid': '36564047', 'type': 'DERIVED', 'citation': 'Harker-Murray P, Mauz-Korholz C, Leblanc T, Mascarin M, Michel G, Cooper S, Beishuizen A, Leger KJ, Amoroso L, Buffardi S, Rigaud C, Hoppe BS, Lisano J, Francis S, Sacchi M, Cole PD, Drachtman RA, Kelly KM, Daw S. Nivolumab and brentuximab vedotin with or without bendamustine for R/R Hodgkin lymphoma in children, adolescents, and young adults. Blood. 2023 Apr 27;141(17):2075-2084. doi: 10.1182/blood.2022017118.'}], 'seeAlsoLinks': [{'url': 'https://www.bms.com/researchers-and-partners/clinical-trials-and-research.html', 'label': 'BMS Clinical Trial Information'}, {'url': 'http://www.BMSClinicalTrials.com', 'label': 'BMS Clinical Trial Patient Recruiting'}]}, 'descriptionModule': {'briefSummary': "The purpose of this study is to determine whether nivolumab plus brentuximab vedotin (followed by brentuximab vedotin plus bendamustine in patient with suboptimal response) is safe and effective in treating patients with Hodgkin's lymphoma (cHL). Eligible patients are children, adolescents, and young adults relapsed or refractory to first line."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT'], 'maximumAge': '30 Years', 'minimumAge': '5 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Classic Hodgkin Lymphoma (cHL), relapsed or refractory\n* Minimal limitation on activities of daily living as measured by Karnofsky ≥ 50 for participants \\> 16 years of age or Lansky ≥ 50 for participants ≤ 16 years of age.\n* One prior anti-cancer therapy that did not work\n\nExclusion Criteria:\n\n* Active, known, or suspected autoimmune disease or infection\n* Active cerebral/meningeal disease related to the underlying malignancy\n* More than one line of anti-cancer therapy or no treatment at all\n* Received a stem cell transplant for Hodgkin Lymphoma and/or a solid organ transplant\n* Prior treatment with any drug that targets T cell co-stimulation pathways (such as checkpoint inhibitors)\n\nOther protocol defined inclusion/exclusion criteria apply'}, 'identificationModule': {'nctId': 'NCT02927769', 'acronym': 'CheckMate 744', 'briefTitle': "A Study of Nivolumab Plus Brentuximab Vedotin in Patients Between 5 and 30 Years Old, With Hodgkin's Lymphoma (cHL), Relapsed or Refractory From First Line Treatment", 'organization': {'class': 'INDUSTRY', 'fullName': 'Bristol-Myers Squibb'}, 'officialTitle': 'Risk-based, Response-adapted, Phase II Open-label Trial of Nivolumab + Brentuximab Vedotin (N + Bv) for Children, Adolescents, and Young Adults With Relapsed/Refractory (R/R) CD30 + Classic Hodgkin Lymphoma (cHL) After Failure of First-line Therapy, Followed by Brentuximab + Bendamustine (Bv + B) for Participants With a Suboptimal Response (CheckMate 744: CHECKpoint Pathway and Nivolumab Clinical Trial Evaluation)', 'orgStudyIdInfo': {'id': 'CA209-744'}, 'secondaryIdInfos': [{'id': '2016-002347-41', 'type': 'EUDRACT_NUMBER'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Nivolumab + brentuximab vedotin', 'interventionNames': ['Biological: Nivolumab', 'Biological: brentuximab vedotin']}, {'type': 'EXPERIMENTAL', 'label': 'brentuximab vedotin + bendamustine', 'interventionNames': ['Biological: brentuximab vedotin', 'Biological: bendamustine']}], 'interventions': [{'name': 'Nivolumab', 'type': 'BIOLOGICAL', 'otherNames': ['BMS-936558', 'Opdivo'], 'description': 'Specified Dose on Specified Days', 'armGroupLabels': ['Nivolumab + brentuximab vedotin']}, {'name': 'brentuximab vedotin', 'type': 'BIOLOGICAL', 'description': 'Specified Dose on Specified Days', 'armGroupLabels': ['Nivolumab + brentuximab vedotin', 'brentuximab vedotin + bendamustine']}, {'name': 'bendamustine', 'type': 'BIOLOGICAL', 'description': 'Specified Dose on Specified Days', 'armGroupLabels': ['brentuximab vedotin + bendamustine']}]}, 'contactsLocationsModule': {'locations': [{'zip': '35233', 'city': 'Birmingham', 'state': 'Alabama', 'country': 'United States', 'facility': "Children's Hospital of Alabama", 'geoPoint': {'lat': 33.52066, 'lon': -86.80249}}, {'zip': '85016', 'city': 'Phoenix', 'state': 'Arizona', 'country': 'United States', 'facility': "Phoenix Children'S Hospital", 'geoPoint': {'lat': 33.44838, 'lon': -112.07404}}, {'zip': '92350', 'city': 'Loma Linda', 'state': 'California', 'country': 'United States', 'facility': 'Loma Linda University Cancer Center', 'geoPoint': {'lat': 34.04835, 'lon': -117.26115}}, {'zip': '93636', 'city': 'Madera', 'state': 'California', 'country': 'United States', 'facility': "Valley Children's Hospital", 'geoPoint': {'lat': 36.96134, 'lon': -120.06072}}, {'zip': '94609', 'city': 'Oakland', 'state': 'California', 'country': 'United States', 'facility': "Children'S Hospital & Research Center At Oakland", 'geoPoint': {'lat': 37.80437, 'lon': -122.2708}}, {'zip': '92868', 'city': 'Orange', 'state': 'California', 'country': 'United States', 'facility': "Children'S Hospital Of Orange County", 'geoPoint': {'lat': 33.78779, 'lon': -117.85311}}, {'zip': '94304', 'city': 'Palo Alto', 'state': 'California', 'country': 'United States', 'facility': "Lucile Packard Children'S Research Hospital/Stanford Univ", 'geoPoint': {'lat': 37.44188, 'lon': -122.14302}}, {'zip': '92109', 'city': 'San Diego', 'state': 'California', 'country': 'United States', 'facility': 'Local Institution - 0091', 'geoPoint': {'lat': 32.71571, 'lon': -117.16472}}, {'zip': '80045', 'city': 'Aurora', 'state': 'Colorado', 'country': 'United States', 'facility': 'Childrens Hospital of Colorado', 'geoPoint': {'lat': 39.72943, 'lon': -104.83192}}, {'zip': '06520', 'city': 'New Haven', 'state': 'Connecticut', 'country': 'United States', 'facility': 'Smilow Cancer Hospital At Yale New Haven Hospital', 'geoPoint': {'lat': 41.30815, 'lon': -72.92816}}, {'zip': '19803', 'city': 'Wilmington', 'state': 'Delaware', 'country': 'United States', 'facility': 'Nemours / A. 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