Ignite Creation Date:
2025-12-24 @ 10:53 PM
Ignite Modification Date:
2025-12-25 @ 8:22 PM
Study NCT ID:
NCT04338269
Status:
COMPLETED
Last Update Posted:
2025-04-04
First Post:
2020-04-06
Is NOT Gene Therapy:
False
Has Adverse Events:
True
Brief Title:
A Study of Atezolizumab in Combination With Cabozantinib Compared to Cabozantinib Alone in Participants With Advanced Renal Cell Carcinoma After Immune Checkpoint Inhibitor Treatment
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24', 'submissionTracking': {'firstMcpInfo': {'postDateStruct': {'date': '2024-01-17', 'type': 'ACTUAL'}}}}, 'conditionBrowseModule': {'meshes': [{'id': 'D002292', 'term': 'Carcinoma, Renal Cell'}], 'ancestors': [{'id': 'D000230', 'term': 'Adenocarcinoma'}, {'id': 'D002277', 'term': 'Carcinoma'}, {'id': 'D009375', 'term': 'Neoplasms, Glandular and Epithelial'}, {'id': 'D009370', 'term': 'Neoplasms by Histologic Type'}, {'id': 'D009369', 'term': 'Neoplasms'}, {'id': 'D007680', 'term': 'Kidney Neoplasms'}, {'id': 'D014571', 'term': 'Urologic Neoplasms'}, {'id': 'D014565', 'term': 'Urogenital Neoplasms'}, {'id': 'D009371', 'term': 'Neoplasms by Site'}, {'id': 'D052776', 'term': 'Female Urogenital Diseases'}, {'id': 'D005261', 'term': 'Female Urogenital Diseases and Pregnancy Complications'}, {'id': 'D000091642', 'term': 'Urogenital Diseases'}, {'id': 'D007674', 'term': 'Kidney Diseases'}, {'id': 'D014570', 'term': 'Urologic Diseases'}, {'id': 'D052801', 'term': 'Male Urogenital Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'C000594389', 'term': 'atezolizumab'}, {'id': 'C558660', 'term': 'cabozantinib'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'genentech@druginfo.com', 'phone': '800 821-8590', 'title': 'Medical Communications', 'organization': 'Hoffmann-La Roche'}, 'certainAgreement': {'otherDetails': "Collaborators are Exelixis and Chugai. The Study being conducted under this Agreement is part of the Overall Study. Investigator is free to publish in reputable journals or to present at professional conferences the results of the Study, but only after the first publication or presentation that involves the Overall Study. The Sponsor may request that Confidential Information be deleted and/or the publication be postponed in order to protect the Sponsor's intellectual property rights.", 'restrictionType': 'OTHER', 'piSponsorEmployee': False, 'restrictiveAgreement': True}}, 'adverseEventsModule': {'timeFrame': 'All Adverse Event (AE) and Serious Adverse Event (SAE) data presented here were collected from date of randomization to primary completion date (up to 2 years 5 months). AE and SAE data continues to be collected until the end of the study and the results will be updated within 1 year of the final collection date.', 'description': 'The incidence, nature, and severity of Adverse Events (AE) and Serious Adverse Events (SAE) were reported, with severity determined according to NCI CTCAE v5.0 of the safety population, defined as all randomized participants who received ≥1 dose of study treatment. All-Cause Mortality data are reported for the all-enrolled population. One participant enrolled but died before receiving study treatment.', 'eventGroups': [{'id': 'EG000', 'title': 'Cabozantinib (Control)', 'description': 'Participants who received treatment until disease progression per RECIST v1.1, unacceptable toxicity, or symptomatic deterioration attributed to disease progression as determined by the investigator.', 'otherNumAtRisk': 256, 'deathsNumAtRisk': 259, 'otherNumAffected': 251, 'seriousNumAtRisk': 256, 'deathsNumAffected': 87, 'seriousNumAffected': 84}, {'id': 'EG001', 'title': 'Atezolizumab + Cabozantinib', 'description': 'Participants who received treatment until disease progression per RECIST v1.1, unacceptable toxicity, or symptomatic deterioration attributed to disease progression as determined by the investigator.', 'otherNumAtRisk': 262, 'deathsNumAtRisk': 263, 'otherNumAffected': 255, 'seriousNumAtRisk': 262, 'deathsNumAffected': 89, 'seriousNumAffected': 126}], 'otherEvents': [{'term': 'Anaemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 256, 'numEvents': 64, 'numAffected': 47}, {'groupId': 'EG001', 'numAtRisk': 262, 'numEvents': 64, 'numAffected': 52}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version 25.'}, {'term': 'Neutropenia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 256, 'numEvents': 35, 'numAffected': 18}, {'groupId': 'EG001', 'numAtRisk': 262, 'numEvents': 30, 'numAffected': 15}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version 25.'}, {'term': 'Thrombocytopenia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 256, 'numEvents': 33, 'numAffected': 23}, {'groupId': 'EG001', 'numAtRisk': 262, 'numEvents': 28, 'numAffected': 21}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version 25.'}, {'term': 'Hypothyroidism', 'stats': [{'groupId': 'EG000', 'numAtRisk': 256, 'numEvents': 111, 'numAffected': 97}, {'groupId': 'EG001', 'numAtRisk': 262, 'numEvents': 115, 'numAffected': 95}], 'organSystem': 'Endocrine disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version 25.'}, {'term': 'Abdominal pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 256, 'numEvents': 41, 'numAffected': 33}, {'groupId': 'EG001', 'numAtRisk': 262, 'numEvents': 16, 'numAffected': 14}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version 25.'}, {'term': 'Abdominal pain upper', 'stats': [{'groupId': 'EG000', 'numAtRisk': 256, 'numEvents': 17, 'numAffected': 17}, {'groupId': 'EG001', 'numAtRisk': 262, 'numEvents': 27, 'numAffected': 25}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version 25.'}, {'term': 'Constipation', 'stats': [{'groupId': 'EG000', 'numAtRisk': 256, 'numEvents': 46, 'numAffected': 42}, {'groupId': 'EG001', 'numAtRisk': 262, 'numEvents': 44, 'numAffected': 37}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version 25.'}, {'term': 'Diarrhoea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 256, 'numEvents': 340, 'numAffected': 179}, {'groupId': 'EG001', 'numAtRisk': 262, 'numEvents': 313, 'numAffected': 170}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version 25.'}, {'term': 'Dyspepsia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 256, 'numEvents': 24, 'numAffected': 20}, {'groupId': 'EG001', 'numAtRisk': 262, 'numEvents': 31, 'numAffected': 26}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version 25.'}, {'term': 'Nausea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 256, 'numEvents': 131, 'numAffected': 92}, {'groupId': 'EG001', 'numAtRisk': 262, 'numEvents': 98, 'numAffected': 76}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version 25.'}, {'term': 'Stomatitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 256, 'numEvents': 48, 'numAffected': 43}, {'groupId': 'EG001', 'numAtRisk': 262, 'numEvents': 66, 'numAffected': 50}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version 25.'}, {'term': 'Vomiting', 'stats': [{'groupId': 'EG000', 'numAtRisk': 256, 'numEvents': 77, 'numAffected': 42}, {'groupId': 'EG001', 'numAtRisk': 262, 'numEvents': 48, 'numAffected': 36}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version 25.'}, {'term': 'Asthenia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 256, 'numEvents': 88, 'numAffected': 75}, {'groupId': 'EG001', 'numAtRisk': 262, 'numEvents': 108, 'numAffected': 75}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version 25.'}, {'term': 'Fatigue', 'stats': [{'groupId': 'EG000', 'numAtRisk': 256, 'numEvents': 83, 'numAffected': 61}, {'groupId': 'EG001', 'numAtRisk': 262, 'numEvents': 92, 'numAffected': 71}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version 25.'}, {'term': 'Mucosal inflammation', 'stats': [{'groupId': 'EG000', 'numAtRisk': 256, 'numEvents': 70, 'numAffected': 51}, {'groupId': 'EG001', 'numAtRisk': 262, 'numEvents': 56, 'numAffected': 45}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version 25.'}, {'term': 'Oedema peripheral', 'stats': [{'groupId': 'EG000', 'numAtRisk': 256, 'numEvents': 12, 'numAffected': 12}, {'groupId': 'EG001', 'numAtRisk': 262, 'numEvents': 16, 'numAffected': 16}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version 25.'}, {'term': 'Pyrexia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 256, 'numEvents': 20, 'numAffected': 15}, {'groupId': 'EG001', 'numAtRisk': 262, 'numEvents': 36, 'numAffected': 32}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version 25.'}, {'term': 'COVID-19', 'stats': [{'groupId': 'EG000', 'numAtRisk': 256, 'numEvents': 32, 'numAffected': 31}, {'groupId': 'EG001', 'numAtRisk': 262, 'numEvents': 39, 'numAffected': 36}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version 25.'}, {'term': 'Urinary tract infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 256, 'numEvents': 19, 'numAffected': 15}, {'groupId': 'EG001', 'numAtRisk': 262, 'numEvents': 43, 'numAffected': 23}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version 25.'}, {'term': 'Alanine aminotransferase increased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 256, 'numEvents': 87, 'numAffected': 57}, {'groupId': 'EG001', 'numAtRisk': 262, 'numEvents': 93, 'numAffected': 62}], 'organSystem': 'Investigations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version 25.'}, {'term': 'Aspartate aminotransferase increased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 256, 'numEvents': 92, 'numAffected': 61}, {'groupId': 'EG001', 'numAtRisk': 262, 'numEvents': 87, 'numAffected': 60}], 'organSystem': 'Investigations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version 25.'}, {'term': 'Blood alkaline phosphatase increased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 256, 'numEvents': 15, 'numAffected': 14}, {'groupId': 'EG001', 'numAtRisk': 262, 'numEvents': 20, 'numAffected': 17}], 'organSystem': 'Investigations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version 25.'}, {'term': 'Blood bilirubin increased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 256, 'numEvents': 24, 'numAffected': 13}, {'groupId': 'EG001', 'numAtRisk': 262, 'numEvents': 14, 'numAffected': 11}], 'organSystem': 'Investigations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version 25.'}, {'term': 'Blood creatinine increased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 256, 'numEvents': 23, 'numAffected': 16}, {'groupId': 'EG001', 'numAtRisk': 262, 'numEvents': 24, 'numAffected': 22}], 'organSystem': 'Investigations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version 25.'}, {'term': 'Blood lactate dehydrogenase increased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 256, 'numEvents': 13, 'numAffected': 11}, {'groupId': 'EG001', 'numAtRisk': 262, 'numEvents': 19, 'numAffected': 15}], 'organSystem': 'Investigations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version 25.'}, {'term': 'Blood thyroid stimulating hormone increased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 256, 'numEvents': 14, 'numAffected': 14}, {'groupId': 'EG001', 'numAtRisk': 262, 'numEvents': 17, 'numAffected': 17}], 'organSystem': 'Investigations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version 25.'}, {'term': 'Weight decreased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 256, 'numEvents': 78, 'numAffected': 64}, {'groupId': 'EG001', 'numAtRisk': 262, 'numEvents': 51, 'numAffected': 46}], 'organSystem': 'Investigations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version 25.'}, {'term': 'Decreased appetite', 'stats': [{'groupId': 'EG000', 'numAtRisk': 256, 'numEvents': 119, 'numAffected': 97}, {'groupId': 'EG001', 'numAtRisk': 262, 'numEvents': 122, 'numAffected': 99}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version 25.'}, {'term': 'Hyperkalaemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 256, 'numEvents': 24, 'numAffected': 15}, {'groupId': 'EG001', 'numAtRisk': 262, 'numEvents': 9, 'numAffected': 4}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version 25.'}, {'term': 'Hypoalbuminaemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 256, 'numEvents': 18, 'numAffected': 17}, {'groupId': 'EG001', 'numAtRisk': 262, 'numEvents': 22, 'numAffected': 19}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version 25.'}, {'term': 'Hypocalcaemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 256, 'numEvents': 27, 'numAffected': 18}, {'groupId': 'EG001', 'numAtRisk': 262, 'numEvents': 27, 'numAffected': 19}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version 25.'}, {'term': 'Hypokalaemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 256, 'numEvents': 39, 'numAffected': 29}, {'groupId': 'EG001', 'numAtRisk': 262, 'numEvents': 40, 'numAffected': 26}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version 25.'}, {'term': 'Hypomagnesaemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 256, 'numEvents': 62, 'numAffected': 46}, {'groupId': 'EG001', 'numAtRisk': 262, 'numEvents': 61, 'numAffected': 37}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version 25.'}, {'term': 'Hypophosphataemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 256, 'numEvents': 35, 'numAffected': 26}, {'groupId': 'EG001', 'numAtRisk': 262, 'numEvents': 30, 'numAffected': 22}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version 25.'}, {'term': 'Arthralgia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 256, 'numEvents': 31, 'numAffected': 25}, {'groupId': 'EG001', 'numAtRisk': 262, 'numEvents': 34, 'numAffected': 29}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version 25.'}, {'term': 'Back pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 256, 'numEvents': 19, 'numAffected': 18}, {'groupId': 'EG001', 'numAtRisk': 262, 'numEvents': 24, 'numAffected': 23}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version 25.'}, {'term': 'Bone pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 256, 'numEvents': 9, 'numAffected': 8}, {'groupId': 'EG001', 'numAtRisk': 262, 'numEvents': 16, 'numAffected': 14}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version 25.'}, {'term': 'Myalgia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 256, 'numEvents': 14, 'numAffected': 13}, {'groupId': 'EG001', 'numAtRisk': 262, 'numEvents': 18, 'numAffected': 18}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version 25.'}, {'term': 'Pain in extremity', 'stats': [{'groupId': 'EG000', 'numAtRisk': 256, 'numEvents': 24, 'numAffected': 22}, {'groupId': 'EG001', 'numAtRisk': 262, 'numEvents': 15, 'numAffected': 14}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version 25.'}, {'term': 'Dizziness', 'stats': [{'groupId': 'EG000', 'numAtRisk': 256, 'numEvents': 10, 'numAffected': 9}, {'groupId': 'EG001', 'numAtRisk': 262, 'numEvents': 28, 'numAffected': 23}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version 25.'}, {'term': 'Dysgeusia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 256, 'numEvents': 43, 'numAffected': 38}, {'groupId': 'EG001', 'numAtRisk': 262, 'numEvents': 40, 'numAffected': 39}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version 25.'}, {'term': 'Headache', 'stats': [{'groupId': 'EG000', 'numAtRisk': 256, 'numEvents': 31, 'numAffected': 27}, {'groupId': 'EG001', 'numAtRisk': 262, 'numEvents': 34, 'numAffected': 27}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version 25.'}, {'term': 'Insomnia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 256, 'numEvents': 13, 'numAffected': 13}, {'groupId': 'EG001', 'numAtRisk': 262, 'numEvents': 20, 'numAffected': 19}], 'organSystem': 'Psychiatric disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version 25.'}, {'term': 'Proteinuria', 'stats': [{'groupId': 'EG000', 'numAtRisk': 256, 'numEvents': 52, 'numAffected': 41}, {'groupId': 'EG001', 'numAtRisk': 262, 'numEvents': 57, 'numAffected': 40}], 'organSystem': 'Renal and urinary disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version 25.'}, {'term': 'Cough', 'stats': [{'groupId': 'EG000', 'numAtRisk': 256, 'numEvents': 27, 'numAffected': 23}, {'groupId': 'EG001', 'numAtRisk': 262, 'numEvents': 35, 'numAffected': 29}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version 25.'}, {'term': 'Dysphonia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 256, 'numEvents': 31, 'numAffected': 30}, {'groupId': 'EG001', 'numAtRisk': 262, 'numEvents': 42, 'numAffected': 37}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version 25.'}, {'term': 'Dyspnoea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 256, 'numEvents': 22, 'numAffected': 21}, {'groupId': 'EG001', 'numAtRisk': 262, 'numEvents': 23, 'numAffected': 21}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version 25.'}, {'term': 'Epistaxis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 256, 'numEvents': 25, 'numAffected': 18}, {'groupId': 'EG001', 'numAtRisk': 262, 'numEvents': 11, 'numAffected': 10}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version 25.'}, {'term': 'Oropharyngeal pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 256, 'numEvents': 9, 'numAffected': 9}, {'groupId': 'EG001', 'numAtRisk': 262, 'numEvents': 22, 'numAffected': 18}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version 25.'}, {'term': 'Pulmonary embolism', 'stats': [{'groupId': 'EG000', 'numAtRisk': 256, 'numEvents': 13, 'numAffected': 13}, {'groupId': 'EG001', 'numAtRisk': 262, 'numEvents': 9, 'numAffected': 8}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version 25.'}, {'term': 'Dry skin', 'stats': [{'groupId': 'EG000', 'numAtRisk': 256, 'numEvents': 23, 'numAffected': 21}, {'groupId': 'EG001', 'numAtRisk': 262, 'numEvents': 13, 'numAffected': 11}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version 25.'}, {'term': 'Hair colour changes', 'stats': [{'groupId': 'EG000', 'numAtRisk': 256, 'numEvents': 19, 'numAffected': 19}, {'groupId': 'EG001', 'numAtRisk': 262, 'numEvents': 9, 'numAffected': 9}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version 25.'}, {'term': 'Palmar-plantar erythrodysaesthesia syndrome', 'stats': [{'groupId': 'EG000', 'numAtRisk': 256, 'numEvents': 130, 'numAffected': 105}, {'groupId': 'EG001', 'numAtRisk': 262, 'numEvents': 133, 'numAffected': 101}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version 25.'}, {'term': 'Pruritus', 'stats': [{'groupId': 'EG000', 'numAtRisk': 256, 'numEvents': 21, 'numAffected': 20}, {'groupId': 'EG001', 'numAtRisk': 262, 'numEvents': 23, 'numAffected': 21}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version 25.'}, {'term': 'Rash', 'stats': [{'groupId': 'EG000', 'numAtRisk': 256, 'numEvents': 32, 'numAffected': 27}, {'groupId': 'EG001', 'numAtRisk': 262, 'numEvents': 41, 'numAffected': 33}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version 25.'}, {'term': 'Hypertension', 'stats': [{'groupId': 'EG000', 'numAtRisk': 256, 'numEvents': 103, 'numAffected': 86}, {'groupId': 'EG001', 'numAtRisk': 262, 'numEvents': 78, 'numAffected': 70}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version 25.'}], 'seriousEvents': [{'term': 'Anaemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 256, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 262, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version 25.'}, {'term': 'Blood loss anaemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 256, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 262, 'numEvents': 2, 'numAffected': 1}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version 25.'}, {'term': 'Neutropenia', 'stats': [{'groupId': 'EG000', 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'numAtRisk': 256, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 262, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version 25.'}, {'term': 'Atrial fibrillation', 'stats': [{'groupId': 'EG000', 'numAtRisk': 256, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 262, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version 25.'}, {'term': 'Bradycardia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 256, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 262, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version 25.'}, {'term': 'Cardiac arrest', 'stats': [{'groupId': 'EG000', 'numAtRisk': 256, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 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{'term': 'Haemoptysis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 256, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 262, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version 25.'}, {'term': 'Immune-mediated lung disease', 'stats': [{'groupId': 'EG000', 'numAtRisk': 256, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 262, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version 25.'}, {'term': 'Laryngeal oedema', 'stats': [{'groupId': 'EG000', 'numAtRisk': 256, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 262, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 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'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version 25.'}, {'term': 'Pneumothorax', 'stats': [{'groupId': 'EG000', 'numAtRisk': 256, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 262, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version 25.'}, {'term': 'Pneumothorax spontaneous', 'stats': [{'groupId': 'EG000', 'numAtRisk': 256, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 262, 'numEvents': 3, 'numAffected': 1}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version 25.'}, {'term': 'Pulmonary embolism', 'stats': [{'groupId': 'EG000', 'numAtRisk': 256, 'numEvents': 6, 'numAffected': 6}, {'groupId': 'EG001', 'numAtRisk': 262, 'numEvents': 11, 'numAffected': 11}], 'organSystem': 'Respiratory, thoracic and mediastinal 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'MedDRA version 25.'}, {'term': 'Hypertension', 'stats': [{'groupId': 'EG000', 'numAtRisk': 256, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 262, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version 25.'}, {'term': 'Thrombosis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 256, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 262, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version 25.'}], 'frequencyThreshold': '5'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Progression Free Survival (PFS) as Assessed by an Independent Review Facility (IRF) (IRF-PFS) According to RECIST v1.1', 'denoms': [{'units': 'Participants', 'counts': [{'value': '259', 'groupId': 'OG000'}, {'value': '263', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Cabozantinib (Control)', 'description': 'Participants who received treatment until disease progression per RECIST v1.1, unacceptable toxicity, or symptomatic deterioration attributed to disease progression as determined by the investigator.'}, {'id': 'OG001', 'title': 'Atezolizumab + Cabozantinib', 'description': 'Participants who received treatment until disease progression per RECIST v1.1, unacceptable toxicity, or symptomatic deterioration attributed to disease progression as determined by the investigator.'}], 'classes': [{'categories': [{'measurements': [{'value': '10.81', 'groupId': 'OG000', 'lowerLimit': '9.95', 'upperLimit': '12.45'}, {'value': '10.55', 'groupId': 'OG001', 'lowerLimit': '9.76', 'upperLimit': '12.25'}]}]}], 'analyses': [{'pValue': '0.7844', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Hazard Ratio (HR)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '1.03', 'ciLowerLimit': '0.83', 'ciUpperLimit': '1.28', 'estimateComment': 'Hazard ratios were estimated by Cox regression. If at least one stratum has \\<10 events at the time of analysis, the stratification factor that contains the level with the smallest number of patients will be removed from the stratified analysis.', 'statisticalMethod': 'Log Rank', 'nonInferiorityType': 'OTHER', 'statisticalComment': 'Stratified', 'nonInferiorityComment': 'Stratified Cox Proportional Hazards Model'}, {'pValue': '0.7195', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Hazard Ratio (HR)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '1.04', 'ciLowerLimit': '0.84', 'ciUpperLimit': '1.29', 'estimateComment': 'Hazard ratios were estimated by Cox regression.', 'groupDescription': 'Cox Proportional Hazards Model', 'statisticalMethod': 'Log Rank', 'nonInferiorityType': 'OTHER', 'statisticalComment': 'Unstratified'}], 'paramType': 'MEDIAN', 'timeFrame': 'From randomization to the first occurrence of disease progression according to RECIST v1.1 (up to 2 years 5 months).', 'description': 'Progression Free Survival (PFS) is defined as the time from randomization to disease progression, as determined by the Independent Review Facility (IRF) per RECIST v1.1, or death from any cause, whichever occurs first. Data for patients who have not experienced disease progression or death were censored at the last tumor assessment date. Data for patients with no postbaseline tumor assessments were censored at the randomization date.', 'unitOfMeasure': 'Months', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'The efficacy evaluable population included all patients who received at least one dose of each drug for their assigned treatment regimen.'}, {'type': 'PRIMARY', 'title': 'Overall Survival (OS)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '259', 'groupId': 'OG000'}, {'value': '263', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Cabozantinib (Control)', 'description': 'Participants who received treatment until disease progression per RECIST v1.1, unacceptable toxicity, or symptomatic deterioration attributed to disease progression as determined by the investigator.'}, {'id': 'OG001', 'title': 'Atezolizumab + Cabozantinib', 'description': 'Participants who received treatment until disease progression per RECIST v1.1, unacceptable toxicity, or symptomatic deterioration attributed to disease progression as determined by the investigator.'}], 'classes': [{'categories': [{'measurements': [{'value': 'NA', 'comment': 'Not estimable due to too few events having occurred.', 'groupId': 'OG000', 'lowerLimit': '21.13', 'upperLimit': 'NA'}, {'value': '25.72', 'comment': 'The upper limit of the 95% CI was not estimable because too few events had occurred.', 'groupId': 'OG001', 'lowerLimit': '21.52', 'upperLimit': 'NA'}]}]}], 'analyses': [{'pValue': '0.6902', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Hazard Ratio (HR)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.94', 'ciLowerLimit': '0.70', 'ciUpperLimit': '1.27', 'estimateComment': 'Hazard ratios were estimated by Cox regression. If at least one stratum has \\<10 events at the time of analysis, the stratification factor that contains the level with the smallest number of patients will be removed from the stratified analysis.', 'statisticalMethod': 'Log Rank', 'nonInferiorityType': 'OTHER', 'statisticalComment': 'Stratified', 'nonInferiorityComment': 'Stratified Cox Proportional Hazards Model'}, {'pValue': '0.7853', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Hazard Ratio (HR)', 'ciPctValue': '95', 'paramValue': '0.96', 'ciLowerLimit': '0.71', 'ciUpperLimit': '1.27', 'estimateComment': 'Hazard ratios were estimated by Cox regression.', 'statisticalMethod': 'Log Rank', 'nonInferiorityType': 'OTHER', 'statisticalComment': 'Unstratified', 'nonInferiorityComment': 'Cox Proportional Hazards Model'}], 'paramType': 'MEDIAN', 'timeFrame': 'From randomization to death due to any cause (up to 2 years 5 months).', 'description': 'From randomization to death due to any cause. Data for patients who are not reported as having died at the date of analysis were censored at the date when they were last known to be alive. Patients who do not have post-baseline information were censored at the date of randomization.', 'unitOfMeasure': 'Months', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'The efficacy evaluable population included all patients who received at least one dose of each drug for their assigned treatment regimen.'}, {'type': 'SECONDARY', 'title': 'Progression Free Survival (PFS) as Assessed by Investigators (INV-PFS), According to RECIST v1.1', 'denoms': [{'units': 'Participants', 'counts': [{'value': '259', 'groupId': 'OG000'}, {'value': '263', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Cabozantinib (Control)', 'description': 'Participants who received treatment until disease progression per RECIST v1.1, unacceptable toxicity, or symptomatic deterioration attributed to disease progression as determined by the investigator.'}, {'id': 'OG001', 'title': 'Atezolizumab + Cabozantinib', 'description': 'Participants who received treatment until disease progression per RECIST v1.1, unacceptable toxicity, or symptomatic deterioration attributed to disease progression as determined by the investigator.'}], 'classes': [{'categories': [{'measurements': [{'value': '10.41', 'groupId': 'OG000', 'lowerLimit': '8.51', 'upperLimit': '12.29'}, {'value': '10.38', 'groupId': 'OG001', 'lowerLimit': '8.41', 'upperLimit': '10.94'}]}]}], 'analyses': [{'pValue': '0.8037', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Hazard Ratio (HR)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '1.03', 'ciLowerLimit': '0.83', 'ciUpperLimit': '1.27', 'estimateComment': 'Hazard ratios were estimated by Cox regression. If at least one stratum has \\<10 events at the time of analysis, the stratification factor that contains the level with the smallest number of patients will be removed from the stratified analysis.', 'statisticalMethod': 'Log Rank', 'nonInferiorityType': 'OTHER', 'statisticalComment': 'Stratified', 'nonInferiorityComment': 'Stratified Cox Proportional Hazards Model'}, {'pValue': '0.7894', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Hazard Ratio (HR)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '1.03', 'ciLowerLimit': '0.83', 'ciUpperLimit': '1.27', 'estimateComment': 'Hazard ratios were estimated by Cox regression.', 'statisticalMethod': 'Log Rank', 'nonInferiorityType': 'OTHER', 'statisticalComment': 'Unstratified', 'nonInferiorityComment': 'Cox Proportional Hazards Model'}], 'paramType': 'MEDIAN', 'timeFrame': 'From randomization to the first occurrence of disease progression according to RECIST v1.1 or death from any cause (whichever occurs first) (up to 2 years 5 months).', 'description': 'Progression Free Survival (PFS) is defined as the time from randomization to disease progression, as determined by the Investigators per RECIST v1.1, or death from any cause, whichever occurs first. Data for patients who have not experienced disease progression or death were censored at the last tumor assessment date. Data for patients with no postbaseline tumor assessments were censored at the randomization date.', 'unitOfMeasure': 'Months', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'The efficacy evaluable population included all patients who received at least one dose of each drug for their assigned treatment regimen.'}, {'type': 'SECONDARY', 'title': 'Investigator-assessed Overall Response Rate (ORR) (INV-ORR) According to RECIST v1.1', 'denoms': [{'units': 'Participants', 'counts': [{'value': '259', 'groupId': 'OG000'}, {'value': '263', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Cabozantinib (Control)', 'description': 'Participants who received treatment until disease progression per RECIST v1.1, unacceptable toxicity, or symptomatic deterioration attributed to disease progression as determined by the investigator.'}, {'id': 'OG001', 'title': 'Atezolizumab + Cabozantinib', 'description': 'Participants who received treatment until disease progression per RECIST v1.1, unacceptable toxicity, or symptomatic deterioration attributed to disease progression as determined by the investigator.'}], 'classes': [{'title': 'Responders (CR + PR)', 'categories': [{'measurements': [{'value': '41.7', 'groupId': 'OG000', 'lowerLimit': '35.63', 'upperLimit': '47.96'}, {'value': '38.0', 'groupId': 'OG001', 'lowerLimit': '32.13', 'upperLimit': '44.19'}]}]}, {'title': 'Complete Response (CR)', 'categories': [{'measurements': [{'value': '0.8', 'groupId': 'OG000', 'lowerLimit': '0.09', 'upperLimit': '2.76'}, {'value': '1.5', 'groupId': 'OG001', 'lowerLimit': '0.42', 'upperLimit': '3.85'}]}]}, {'title': 'Partial Response (PR)', 'categories': [{'measurements': [{'value': '40.9', 'groupId': 'OG000', 'lowerLimit': '34.88', 'upperLimit': '47.18'}, {'value': '36.5', 'groupId': 'OG001', 'lowerLimit': '30.67', 'upperLimit': '42.64'}]}]}, {'title': 'Stable Disease (SD)', 'categories': [{'measurements': [{'value': '46.3', 'groupId': 'OG000', 'lowerLimit': '40.14', 'upperLimit': '52.61'}, {'value': '48.3', 'groupId': 'OG001', 'lowerLimit': '42.11', 'upperLimit': '54.51'}]}]}, {'title': 'Progressive Disease (PD)', 'categories': [{'measurements': [{'value': '6.6', 'groupId': 'OG000', 'lowerLimit': '3.87', 'upperLimit': '10.30'}, {'value': '9.1', 'groupId': 'OG001', 'lowerLimit': '5.93', 'upperLimit': '13.27'}]}]}, {'title': 'Not Evaluable', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000', 'lowerLimit': '0', 'upperLimit': '1.4'}, {'value': '0.8', 'groupId': 'OG001', 'lowerLimit': '0.1', 'upperLimit': '2.7'}]}]}, {'title': 'Missing', 'categories': [{'measurements': [{'value': '5.4', 'groupId': 'OG000', 'lowerLimit': '3', 'upperLimit': '8.9'}, {'value': '3.8', 'groupId': 'OG001', 'lowerLimit': '1.8', 'upperLimit': '6.9'}]}]}], 'analyses': [{'pValue': '0.4306', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Odds Ratio (OR)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-3.68', 'ciLowerLimit': '-12.45', 'ciUpperLimit': '5.10', 'estimateComment': 'Odds ratio 95% CI was constructed using the Wald method. If at least one stratum has \\<10 events at the time of analysis, the stratification factor containing the level with the smallest number of patients will be removed from the stratified analysis', 'statisticalMethod': 'Cochran-Mantel-Haenszel', 'nonInferiorityType': 'OTHER', 'nonInferiorityComment': 'Difference in Overall Response Rates'}], 'paramType': 'NUMBER', 'timeFrame': 'From randomization to the first occurrence of disease progression according to RECIST v1.1 or death from any cause (whichever occurs first) (up to 2 years 5 months).', 'description': 'Overall Response Rate (ORR) is defined as the proportion of participants who had an objective response (complete response \\[CR\\] or partial response \\[PR\\]) on two consecutive occasions at least 4 weeks apart according to RECIST v1.1. in the ORR evaluable population, defined as patients with measurable disease at baseline.', 'unitOfMeasure': 'Percentage of Participants', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': "The ORR evaluable population is defined as participants with measurable disease at baseline. There were discrepancies between the IRF and INV assessments of participants' measurable diseases at baseline, which are reflected in the number of participants analyzed."}, {'type': 'SECONDARY', 'title': 'Independent Review Facility (IRF)-Assessed Overall Response Rate (ORR) (IRF-ORR) According to RECIST v1.1', 'denoms': [{'units': 'Participants', 'counts': [{'value': '254', 'groupId': 'OG000'}, {'value': '259', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Cabozantinib (Control)', 'description': 'Participants who received treatment until disease progression per RECIST v1.1, unacceptable toxicity, or symptomatic deterioration attributed to disease progression as determined by the investigator.'}, {'id': 'OG001', 'title': 'Atezolizumab + Cabozantinib', 'description': 'Participants who received treatment until disease progression per RECIST v1.1, unacceptable toxicity, or symptomatic deterioration attributed to disease progression as determined by the investigator.'}], 'classes': [{'title': 'Responders (CR + PR)', 'categories': [{'measurements': [{'value': '40.9', 'groupId': 'OG000', 'lowerLimit': '34.84', 'upperLimit': '47.27'}, {'value': '40.5', 'groupId': 'OG001', 'lowerLimit': '34.51', 'upperLimit': '46.79'}]}]}, {'title': 'Complete Response (CR)', 'categories': [{'measurements': [{'value': '0.8', 'groupId': 'OG000', 'lowerLimit': '0.10', 'upperLimit': '2.82'}, {'value': '0', 'groupId': 'OG001', 'lowerLimit': '0.00', 'upperLimit': '1.41'}]}]}, {'title': 'Partial Response (PR)', 'categories': [{'measurements': [{'value': '40.2', 'groupId': 'OG000', 'lowerLimit': '34.08', 'upperLimit': '46.47'}, {'value': '40.5', 'groupId': 'OG001', 'lowerLimit': '34.51', 'upperLimit': '46.79'}]}]}, {'title': 'Stable Disease (SD)', 'categories': [{'measurements': [{'value': '47.6', 'groupId': 'OG000', 'lowerLimit': '41.36', 'upperLimit': '53.97'}, {'value': '50.6', 'groupId': 'OG001', 'lowerLimit': '44.32', 'upperLimit': '56.82'}]}]}, {'title': 'Progressive Disease (PD)', 'categories': [{'measurements': [{'value': '5.1', 'groupId': 'OG000', 'lowerLimit': '2.75', 'upperLimit': '8.59'}, {'value': '4.2', 'groupId': 'OG001', 'lowerLimit': '2.14', 'upperLimit': '7.47'}]}]}, {'title': 'Not Evaluable', 'categories': [{'measurements': [{'value': '0.8', 'groupId': 'OG000', 'lowerLimit': '0.1', 'upperLimit': '2.8'}, {'value': '0.8', 'groupId': 'OG001', 'lowerLimit': '0.1', 'upperLimit': '2.8'}]}]}, {'title': 'Missing', 'categories': [{'measurements': [{'value': '5.5', 'groupId': 'OG000', 'lowerLimit': '3', 'upperLimit': '9.1'}, {'value': '3.9', 'groupId': 'OG001', 'lowerLimit': '1.9', 'upperLimit': '7'}]}]}], 'analyses': [{'pValue': '0.9893', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Odds Ratio (OR)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '1.00', 'ciLowerLimit': '0.70', 'ciUpperLimit': '1.43', 'estimateComment': 'Odds ratio 95% CI was constructed using the Wald method. If at least one stratum has \\<10 events at the time of analysis, the stratification factor containing the level with the smallest number of patients will be removed from the stratified analysis', 'statisticalMethod': 'Cochran-Mantel-Haenszel', 'nonInferiorityType': 'OTHER', 'nonInferiorityComment': 'Difference in Overall Response Rates'}], 'paramType': 'NUMBER', 'timeFrame': 'From randomization to the first occurrence of disease progression according to RECIST v1.1 or death from any cause (whichever occurs first) (up to 2 years 5 months).', 'description': 'Overall Response Rate (ORR) is defined as the proportion of participants who had an objective response (complete response \\[CR\\] or partial response \\[PR\\]) on two consecutive occasions at least 4 weeks apart according to RECIST v1.1. in the ORR evaluable population, defined as patients with measurable disease at baseline.', 'unitOfMeasure': 'Percentage of Participants', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': "The ORR evaluable population is defined as participants with measurable disease at baseline. There were discrepancies between the IRF and INV assessments of participants' measurable diseases at baseline, which are reflected in the number of participants analyzed."}, {'type': 'SECONDARY', 'title': 'Investigator-assessed Duration of Response (DOR) (INV-DOR) According to RECIST v1.1', 'denoms': [{'units': 'Participants', 'counts': [{'value': '108', 'groupId': 'OG000'}, {'value': '100', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Cabozantinib (Control)', 'description': 'Participants who received treatment until disease progression per RECIST v1.1, unacceptable toxicity, or symptomatic deterioration attributed to disease progression as determined by the investigator.'}, {'id': 'OG001', 'title': 'Atezolizumab + Cabozantinib', 'description': 'Participants who received treatment until disease progression per RECIST v1.1, unacceptable toxicity, or symptomatic deterioration attributed to disease progression as determined by the investigator.'}], 'classes': [{'categories': [{'measurements': [{'value': '12.19', 'groupId': 'OG000', 'lowerLimit': '9.72', 'upperLimit': '14.52'}, {'value': 'NA', 'comment': 'Not estimable due to too few events having occurred.', 'groupId': 'OG001', 'lowerLimit': '10.38', 'upperLimit': 'NA'}]}]}], 'analyses': [{'pValue': '0.0816', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Hazard Ratio (HR)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.70', 'ciLowerLimit': '0.47', 'ciUpperLimit': '1.05', 'estimateComment': 'Hazard ratios were estimated by Cox regression. If at least one stratum has \\<10 events at the time of analysis, the stratification factor that contains the level with the smallest number of patients will be removed from the stratified analysis.', 'statisticalMethod': 'Log Rank', 'nonInferiorityType': 'OTHER', 'statisticalComment': 'Stratified', 'nonInferiorityComment': 'Difference between Duration of Response (DOR) rates'}, {'pValue': '0.1099', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Hazard Ratio (HR)', 'ciPctValue': '95', 'paramValue': '0.72', 'ciLowerLimit': '0.49', 'ciUpperLimit': '1.08', 'estimateComment': 'Hazard ratios were estimated by Cox regression. If at least one stratum has \\<10 events at the time of analysis, the stratification factor that contains the level with the smallest number of patients will be removed from the stratified analysis.', 'statisticalMethod': 'Log Rank', 'nonInferiorityType': 'OTHER', 'statisticalComment': 'Unstratified', 'nonInferiorityComment': 'Difference between Duration of Response (DOR) rates'}], 'paramType': 'MEDIAN', 'timeFrame': 'From the date of first occurrence of a documented objective response to disease progression or death from any cause, whichever occurs first (up to 2 years 5 months)', 'description': 'Duration of Response (DOR) is defined as the time from the first occurrence of a confirmed objective response (complete response \\[CR\\] or partial response \\[PR\\]) to disease progression, or death, whichever occurs first. Data for participants who have not experienced disease progression or death will be censored at the last tumor assessment date. If no tumor assessments were performed after the date of the first occurrence of CR or PR, data for DOR will be censored at the date of the first occurrence of CR or PR.', 'unitOfMeasure': 'Months', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'The DOR evaluable population is defined as participants with measurable disease at baseline who experienced a a confirmed objective response (complete response \\[CR\\] or partial response \\[PR\\]).'}, {'type': 'SECONDARY', 'title': 'Independent Review Facility (IRF)-Assessed Duration of Response (DOR) (IRF-DOR) According to RECIST v1.1', 'denoms': [{'units': 'Participants', 'counts': [{'value': '104', 'groupId': 'OG000'}, {'value': '105', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Cabozantinib (Control)', 'description': 'Participants who received treatment until disease progression per RECIST v1.1, unacceptable toxicity, or symptomatic deterioration attributed to disease progression as determined by the investigator.'}, {'id': 'OG001', 'title': 'Atezolizumab + Cabozantinib', 'description': 'Participants who received treatment until disease progression per RECIST v1.1, unacceptable toxicity, or symptomatic deterioration attributed to disease progression as determined by the investigator.'}], 'classes': [{'categories': [{'measurements': [{'value': '14.75', 'groupId': 'OG000', 'lowerLimit': '11.30', 'upperLimit': '20.01'}, {'value': '12.65', 'groupId': 'OG001', 'lowerLimit': '10.51', 'upperLimit': '17.38'}]}]}], 'analyses': [{'pValue': '0.8354', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Hazard Ratio (HR)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '1.04', 'ciLowerLimit': '0.70', 'ciUpperLimit': '1.54', 'estimateComment': 'Hazard ratios were estimated by Cox regression. If at least one stratum has \\<10 events at the time of analysis, the stratification factor that contains the level with the smallest number of patients will be removed from the stratified analysis.', 'statisticalMethod': 'Log Rank', 'nonInferiorityType': 'OTHER', 'statisticalComment': 'Stratified', 'nonInferiorityComment': 'Difference between Duration of Response (DOR) rates'}, {'pValue': '0.8159', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Hazard Ratio (HR)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '1.05', 'ciLowerLimit': '0.71', 'ciUpperLimit': '1.55', 'estimateComment': 'Hazard ratios were estimated by Cox regression. If at least one stratum has \\<10 events at the time of analysis, the stratification factor that contains the level with the smallest number of patients will be removed from the stratified analysis.', 'statisticalMethod': 'Log Rank', 'nonInferiorityType': 'OTHER', 'statisticalComment': 'Unstratified', 'nonInferiorityComment': 'Difference between Duration of Response (DOR) rates'}], 'paramType': 'MEDIAN', 'timeFrame': 'From the date of first occurrence of a documented objective response to disease progression or death from any cause, whichever occurs first (up to 2 years 5 months)', 'description': 'Duration of Response (DOR) is defined as the time from the first occurrence of a confirmed objective response (complete response \\[CR\\] or partial response \\[PR\\]) to disease progression, or death, whichever occurs first. Data for participants who have not experienced disease progression or death will be censored at the last tumor assessment date. If no tumor assessments were performed after the date of the first occurrence of CR or PR, data for DOR will be censored at the date of the first occurrence of CR or PR.', 'unitOfMeasure': 'Months', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'The DOR evaluable population is defined as participants with measurable disease at baseline who experienced a a confirmed objective response (complete response \\[CR\\] or partial response \\[PR\\]).'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Cabozantinib (Control)', 'description': 'Participants who received treatment until disease progression per RECIST v1.1, unacceptable toxicity, or symptomatic deterioration attributed to disease progression as determined by the investigator.'}, {'id': 'FG001', 'title': 'Atezolizumab + Cabozantinib', 'description': 'Participants who received treatment until disease progression per RECIST v1.1, unacceptable toxicity, or symptomatic 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{'type': 'Physician Decision', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '0'}]}, {'type': 'Withdrawal by Subject', 'reasons': [{'groupId': 'FG000', 'numSubjects': '14'}, {'groupId': 'FG001', 'numSubjects': '11'}]}]}], 'recruitmentDetails': 'The study was conducted at 147 locations in 15 countries: Argentina, Australia, Canada, Denmark, France, Germany, Greece, Italy, Japan, Republic of Korea, Poland, Russian Federation, Spain, United Kingdom, United States of America.'}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '259', 'groupId': 'BG000'}, {'value': '263', 'groupId': 'BG001'}, {'value': '522', 'groupId': 'BG002'}]}], 'groups': [{'id': 'BG000', 'title': 'Cabozantinib (Control)', 'description': 'Participants who received treatment until disease progression per RECIST v1.1, unacceptable toxicity, or symptomatic deterioration attributed to disease progression as determined by the investigator.'}, {'id': 'BG001', 'title': 'Atezolizumab + Cabozantinib', 'description': 'Participants who received treatment until disease progression per RECIST v1.1, unacceptable toxicity, or symptomatic deterioration attributed to disease progression as determined by the investigator.'}, {'id': 'BG002', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Categorical', 'classes': [{'categories': [{'title': '<=18 years', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}, {'title': 'Between 18 and 65 years', 'measurements': [{'value': '144', 'groupId': 'BG000'}, {'value': '153', 'groupId': 'BG001'}, {'value': '297', 'groupId': 'BG002'}]}, {'title': '>=65 years', 'measurements': [{'value': '115', 'groupId': 'BG000'}, {'value': '110', 'groupId': 'BG001'}, {'value': '225', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Age, Customized', 'classes': [{'categories': [{'measurements': [{'value': '61.8', 'spread': '10.2', 'groupId': 'BG000'}, {'value': '61.8', 'spread': '9.9', 'groupId': 'BG001'}, {'value': '61.8', 'spread': '10.0', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'Number', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '62', 'groupId': 'BG000'}, {'value': '59', 'groupId': 'BG001'}, {'value': '121', 'groupId': 'BG002'}]}, {'title': 'Male', 'measurements': [{'value': '197', 'groupId': 'BG000'}, {'value': '204', 'groupId': 'BG001'}, {'value': '401', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Ethnicity (NIH/OMB)', 'classes': [{'categories': [{'title': 'Hispanic or Latino', 'measurements': [{'value': '29', 'groupId': 'BG000'}, {'value': '23', 'groupId': 'BG001'}, {'value': '52', 'groupId': 'BG002'}]}, {'title': 'Not Hispanic or Latino', 'measurements': [{'value': '212', 'groupId': 'BG000'}, {'value': '232', 'groupId': 'BG001'}, {'value': '444', 'groupId': 'BG002'}]}, {'title': 'Unknown or Not Reported', 'measurements': [{'value': '18', 'groupId': 'BG000'}, {'value': '8', 'groupId': 'BG001'}, {'value': '26', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Race (NIH/OMB)', 'classes': [{'categories': [{'title': 'American Indian or Alaska Native', 'measurements': [{'value': '1', 'groupId': 'BG000'}, {'value': '1', 'groupId': 'BG001'}, {'value': '2', 'groupId': 'BG002'}]}, {'title': 'Asian', 'measurements': [{'value': '23', 'groupId': 'BG000'}, {'value': '33', 'groupId': 'BG001'}, {'value': '56', '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': '6', 'groupId': 'BG000'}, {'value': '2', 'groupId': 'BG001'}, {'value': '8', 'groupId': 'BG002'}]}, {'title': 'White', 'measurements': [{'value': '213', 'groupId': 'BG000'}, {'value': '219', 'groupId': 'BG001'}, {'value': '432', 'groupId': 'BG002'}]}, {'title': 'More than one race', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '1', 'groupId': 'BG001'}, {'value': '1', 'groupId': 'BG002'}]}, {'title': 'Unknown or Not Reported', 'measurements': [{'value': '16', 'groupId': 'BG000'}, {'value': '6', 'groupId': 'BG001'}, {'value': '22', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}]}}, 'documentSection': {'largeDocumentModule': {'largeDocs': [{'date': '2021-03-24', 'size': 1760680, 'label': 'Study Protocol', 'hasIcf': False, 'hasSap': False, 'filename': 'Prot_000.pdf', 'typeAbbrev': 'Prot', 'uploadDate': '2023-12-20T03:02', 'hasProtocol': True}, {'date': '2022-09-02', 'size': 469481, 'label': 'Statistical Analysis Plan', 'hasIcf': False, 'hasSap': True, 'filename': 'SAP_001.pdf', 'typeAbbrev': 'SAP', 'uploadDate': '2023-12-20T03:02', 'hasProtocol': False}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE3'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 522}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2020-07-28', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-03', 'completionDateStruct': {'date': '2025-03-24', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2025-03-27', 'studyFirstSubmitDate': '2020-04-06', 'resultsFirstSubmitDate': '2023-12-20', 'studyFirstSubmitQcDate': '2020-04-06', 'lastUpdatePostDateStruct': {'date': '2025-04-04', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2024-02-05', 'studyFirstPostDateStruct': {'date': '2020-04-08', 'type': 'ACTUAL'}, 'resultsFirstPostDateStruct': {'date': '2024-02-28', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2023-01-03', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Progression Free Survival (PFS) as Assessed by an Independent Review Facility (IRF) (IRF-PFS) According to RECIST v1.1', 'timeFrame': 'From randomization to the first occurrence of disease progression according to RECIST v1.1 (up to 2 years 5 months).', 'description': 'Progression Free Survival (PFS) is defined as the time from randomization to disease progression, as determined by the Independent Review Facility (IRF) per RECIST v1.1, or death from any cause, whichever occurs first. Data for patients who have not experienced disease progression or death were censored at the last tumor assessment date. Data for patients with no postbaseline tumor assessments were censored at the randomization date.'}, {'measure': 'Overall Survival (OS)', 'timeFrame': 'From randomization to death due to any cause (up to 2 years 5 months).', 'description': 'From randomization to death due to any cause. Data for patients who are not reported as having died at the date of analysis were censored at the date when they were last known to be alive. Patients who do not have post-baseline information were censored at the date of randomization.'}], 'secondaryOutcomes': [{'measure': 'Progression Free Survival (PFS) as Assessed by Investigators (INV-PFS), According to RECIST v1.1', 'timeFrame': 'From randomization to the first occurrence of disease progression according to RECIST v1.1 or death from any cause (whichever occurs first) (up to 2 years 5 months).', 'description': 'Progression Free Survival (PFS) is defined as the time from randomization to disease progression, as determined by the Investigators per RECIST v1.1, or death from any cause, whichever occurs first. Data for patients who have not experienced disease progression or death were censored at the last tumor assessment date. Data for patients with no postbaseline tumor assessments were censored at the randomization date.'}, {'measure': 'Investigator-assessed Overall Response Rate (ORR) (INV-ORR) According to RECIST v1.1', 'timeFrame': 'From randomization to the first occurrence of disease progression according to RECIST v1.1 or death from any cause (whichever occurs first) (up to 2 years 5 months).', 'description': 'Overall Response Rate (ORR) is defined as the proportion of participants who had an objective response (complete response \\[CR\\] or partial response \\[PR\\]) on two consecutive occasions at least 4 weeks apart according to RECIST v1.1. in the ORR evaluable population, defined as patients with measurable disease at baseline.'}, {'measure': 'Independent Review Facility (IRF)-Assessed Overall Response Rate (ORR) (IRF-ORR) According to RECIST v1.1', 'timeFrame': 'From randomization to the first occurrence of disease progression according to RECIST v1.1 or death from any cause (whichever occurs first) (up to 2 years 5 months).', 'description': 'Overall Response Rate (ORR) is defined as the proportion of participants who had an objective response (complete response \\[CR\\] or partial response \\[PR\\]) on two consecutive occasions at least 4 weeks apart according to RECIST v1.1. in the ORR evaluable population, defined as patients with measurable disease at baseline.'}, {'measure': 'Investigator-assessed Duration of Response (DOR) (INV-DOR) According to RECIST v1.1', 'timeFrame': 'From the date of first occurrence of a documented objective response to disease progression or death from any cause, whichever occurs first (up to 2 years 5 months)', 'description': 'Duration of Response (DOR) is defined as the time from the first occurrence of a confirmed objective response (complete response \\[CR\\] or partial response \\[PR\\]) to disease progression, or death, whichever occurs first. Data for participants who have not experienced disease progression or death will be censored at the last tumor assessment date. If no tumor assessments were performed after the date of the first occurrence of CR or PR, data for DOR will be censored at the date of the first occurrence of CR or PR.'}, {'measure': 'Independent Review Facility (IRF)-Assessed Duration of Response (DOR) (IRF-DOR) According to RECIST v1.1', 'timeFrame': 'From the date of first occurrence of a documented objective response to disease progression or death from any cause, whichever occurs first (up to 2 years 5 months)', 'description': 'Duration of Response (DOR) is defined as the time from the first occurrence of a confirmed objective response (complete response \\[CR\\] or partial response \\[PR\\]) to disease progression, or death, whichever occurs first. Data for participants who have not experienced disease progression or death will be censored at the last tumor assessment date. If no tumor assessments were performed after the date of the first occurrence of CR or PR, data for DOR will be censored at the date of the first occurrence of CR or PR.'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': True, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Carcinoma, Renal Cell']}, 'referencesModule': {'references': [{'pmid': '37290461', 'type': 'DERIVED', 'citation': 'Pal SK, Albiges L, Tomczak P, Suarez C, Voss MH, de Velasco G, Chahoud J, Mochalova A, Procopio G, Mahammedi H, Zengerling F, Kim C, Osawa T, Angel M, Gupta S, Khan O, Bergthold G, Liu B, Kalaitzidou M, Huseni M, Scheffold C, Powles T, Choueiri TK. Atezolizumab plus cabozantinib versus cabozantinib monotherapy for patients with renal cell carcinoma after progression with previous immune checkpoint inhibitor treatment (CONTACT-03): a multicentre, randomised, open-label, phase 3 trial. Lancet. 2023 Jul 15;402(10397):185-195. doi: 10.1016/S0140-6736(23)00922-4. Epub 2023 Jun 5.'}, {'pmid': '35304832', 'type': 'DERIVED', 'citation': 'Yang Y, Psutka SP, Parikh AB, Li M, Collier K, Miah A, Mori SV, Hinkley M, Tykodi SS, Hall E, Thompson JA, Yin M. Combining immune checkpoint inhibition plus tyrosine kinase inhibition as first and subsequent treatments for metastatic renal cell carcinoma. Cancer Med. 2022 Aug;11(16):3106-3114. doi: 10.1002/cam4.4679. Epub 2022 Mar 18.'}]}, 'descriptionModule': {'briefSummary': 'This is a Phase III, multicenter, randomized, open-label study designed to evaluate the efficacy and safety of atezolizumab given in combination with cabozantinib versus cabozantinib alone in participants with inoperable, locally advanced, or metastatic renal cell carcinoma (RCC) who experienced radiographic tumor progression during or after Immune Checkpoint Inhibitor (ICI) treatment in the metastatic setting.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': "Inclusion Criteria:\n\n* Histologically confirmed locally advanced or metastatic clear cell or non-clear cell (papillary, chromophobe, and unclassified only) RCC. RCC with sarcomatoid features is allowed. Patients with the chromophobe subtype of non-clear cell RCC must have sarcomatoid differentiation.\n* Radiographic disease progression to prior ICI therapy for RCC. Patients who experienced radiographic tumor progression during or within 6 months after the last dose of adjuvant ICI are also eligible. ICI is defined by anti-PD-L1 or anti-PD1 antibody including atezolizumab, avelumab, pembrolizumab, durvalumab, or nivolumab. Only patients for whom the immediate preceding line of therapy was an ICI are allowed.\n* Measurable disease per RECIST v1.1\n* Evaluable IMDC risk score\n* Archival tumor specimen, and pretreatment tumor tissue from fresh biopsy at screening, if clinically feasible. Both archival and fresh samples are preferred.\n* KPS score of \\>=70\n* Recovery to baseline or Grade \\</= 1 NCI CTCAE v5.0 from toxicities related to any prior treatments, unless adverse events are clinically nonsignificant and/or stable in the opinion of the investigator. Grade 2 alopecia is allowed for study participation\n* Adequate hematologic and end-organ function\n* Negative HIV test at screening\n* Negative hepatitis B testing at screening\n* Negative hepatitis C virus (HCV) antibody test at screening, or positive HCV antibody test followed by a negative HCV RNA test at screening\n* For women of childbearing potential: agreement to remain abstinent (refrain from heterosexual intercourse) or use contraception and agreement to refrain from donating eggs\n* For men: agreement to remain abstinent (refrain from heterosexual intercourse) or use a condom, and agreement to refrain from donating sperm\n\nExclusion Criteria:\n\n* Treatment with anti-cancer therapy within 14 days prior to initiation of study treatment\n* Patients received cabozantinib at any time prior to screening\n* Patients who received more than one ICI treatment in the locally advanced or metastatic setting\n* Patients who received more than two prior lines of therapy in the locally advanced or metastatic setting\n* Patients who have received a mammalian target of rapamycin (mTOR) inhibitor in any setting\n* Symptomatic, untreated, or actively progressing CNS metastases\n* History of leptomeningeal disease\n* Uncontrolled pleural effusion, pericardial effusion, or ascites requiring recurrent drainage procedures\n* Uncontrolled or symptomatic hypercalcemia or symptomatic hypercalcemia requiring continued use of bisphosphonate therapy or denosumab\n* History of malignancy other than renal carcinoma within 5 years prior to screening, with the exception of malignancies with a negligible risk of metastasis or death\n* Radiotherapy for RCC within 14 days prior to Day 1 of Cycle 1\n* Active tuberculosis\n* Major surgical procedure, other than for diagnosis, within 4 weeks prior to initiation of study treatment, or anticipation of need for a major surgical procedure during the study\n* Pregnancy or breastfeeding, or intention of becoming pregnant during study treatment or within 5 months after final dose of atezolizumab and 4 months after final dose of cabozantinib\n* Severe infection within 4 weeks prior to initiation of study treatment, including, but not limited to, hospitalization for complications of infection, bacteremia, or severe pneumonia, or any active infection that, in the opinion of the investigator, could impact patient safety\n* Pharmacologically uncompensated, symptomatic hypothyroidism\n* Uncontrolled hypertension defined as sustained blood pressure \\>150 mm Hg systolic or \\> 90 mm Hg diastolic despite optimal antihypertensive treatment (all countries except France); sustained BP \\> 140 mmHg systolic or \\> 90 mmHg diastolic despite optimal antihypertensive treatment (France only)\n* Significant cardiovascular disease (such as New York Heart Association Class II or greater cardiac disease, unstable arrhythmia, or unstable angina) within 3 months prior to initiation of study treatment\n* Significant vascular disease (e.g., aortic aneurysm or arterial dissection requiring surgical repair or recent peripheral arterial thrombosis) within 6 months prior to Day 1 of Cycle 1\n* History of congenital QT syndrome\n* History or presence of an abnormal ECG that is clinically significant in the investigator's opinion\n* Concomitant anticoagulation with coumarin agents (e.g., warfarin), direct thrombin inhibitor dabigatran, direct factor Xa inhibitor betrixaban, or platelet inhibitors (e.g. clopidogrel)"}, 'identificationModule': {'nctId': 'NCT04338269', 'acronym': 'CONTACT-03', 'briefTitle': 'A Study of Atezolizumab in Combination With Cabozantinib Compared to Cabozantinib Alone in Participants With Advanced Renal Cell Carcinoma After Immune Checkpoint Inhibitor Treatment', 'organization': {'class': 'INDUSTRY', 'fullName': 'Hoffmann-La Roche'}, 'officialTitle': 'A Phase III, Multicenter, Randomized, Open-Label Study to Evaluate the Efficacy and Safety of Atezolizumab Given in Combination With Cabozantinib Versus Cabozantinib Alone in Patients With Inoperable, Locally Advanced, or Metastatic Renal Cell Carcinoma Who Experienced Radiographic Tumor Progression During or After Immune Checkpoint Inhibitor Treatment', 'orgStudyIdInfo': {'id': 'WO41994'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Atezo+Cabo', 'description': 'Participants will receive atezolizumab every 3 weeks on Day 1 of each 21-day cycle (1 cycle=21 days) plus oral tablets of cabozantinib every day.', 'interventionNames': ['Drug: Atezolizumab', 'Drug: Cabozantinib']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Cabozantinib', 'description': 'Participants will receive cabozantinib every day.', 'interventionNames': ['Drug: Cabozantinib']}], 'interventions': [{'name': 'Atezolizumab', 'type': 'DRUG', 'otherNames': ['Tecentriq'], 'description': 'Atezolizumab 1200 mg will be administered at a fixed dose on Day 1 of each 21-day cycle by IV infusion every 3 weeks.', 'armGroupLabels': ['Atezo+Cabo']}, {'name': 'Cabozantinib', 'type': 'DRUG', 'otherNames': ['Cabometyx'], 'description': 'Cabozantinib 60 mg (three 20-mg tablets) administered orally once daily.', 'armGroupLabels': ['Atezo+Cabo', 'Cabozantinib']}]}, 'contactsLocationsModule': {'locations': [{'zip': '85724-5030', 'city': 'Tucson', 'state': 'Arizona', 'country': 'United States', 'facility': 'University of Arizona', 'geoPoint': {'lat': 32.22174, 'lon': -110.92648}}, {'zip': '91010', 'city': 'Duarte', 'state': 'California', 'country': 'United States', 'facility': 'City of Hope Comprehensive Cancer Center', 'geoPoint': {'lat': 34.13945, 'lon': -117.97729}}, {'zip': '92093', 'city': 'La Jolla', 'state': 'California', 'country': 'United States', 'facility': 'UC San Diego Health System', 'geoPoint': {'lat': 32.84727, 'lon': -117.2742}}, {'zip': '90095', 'city': 'Los Angeles', 'state': 'California', 'country': 'United States', 'facility': 'UCLA', 'geoPoint': {'lat': 34.05223, 'lon': -118.24368}}, {'zip': '80045', 'city': 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