Ignite Creation Date:
2025-12-25 @ 2:32 AM
Ignite Modification Date:
2025-12-26 @ 1:08 AM
Study NCT ID:
NCT03480334
Status:
ACTIVE_NOT_RECRUITING
Last Update Posted:
2025-04-03
First Post:
2018-03-21
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Abscopal Effect of Radiotherapy and Nivolumab in Relapsed Hodgkin Lymphoma After Anti-PD1 Therapy
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'interventionBrowseModule': {'meshes': [{'id': 'D000077594', 'term': 'Nivolumab'}, {'id': 'D011878', 'term': 'Radiotherapy'}], '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': 'D013812', 'term': 'Therapeutics'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 26}}, 'statusModule': {'overallStatus': 'ACTIVE_NOT_RECRUITING', 'startDateStruct': {'date': '2019-12-05', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-03', 'completionDateStruct': {'date': '2025-05-04', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-03-31', 'studyFirstSubmitDate': '2018-03-21', 'studyFirstSubmitQcDate': '2018-03-21', 'lastUpdatePostDateStruct': {'date': '2025-04-03', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2018-03-29', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2024-05-04', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Abscopal response rate (ARR-6)', 'timeFrame': '12 weeks', 'description': 'Abscopal response rate (ARR-6) with abscopal response centrally confirmed as restaging result after RT to a single lesion and at least four but not more than six nivolumab infusions (RE-6 result)'}]}, 'oversightModule': {'isUsExport': False, 'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Classical Hodgkin Lymphoma']}, 'descriptionModule': {'briefSummary': 'The aim of the trial is to improve efficacy of nivolumab in patients with relapsed or refractory HL who recently progressed on anti-PD1 therapy. Nivolumab is highly effective and well tolerated in rrHL, nevertheless CR-rates are low and a considerable proportion of patients suffers from progressive disease. Localized RT induces an immunogenic effect which might work synergistically and facilitate augmented systemic (i.e. abscopal) responses in combination with nivolumab.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Progression of refractory or relapsed cHL during treatment with an anti-PD1 agent\n* At least two distinct FDG-avid HL-lesions with at least 5 cm distance between them, and one of them considered eligible for irradiation with 20Gy based on localization and prior RT exposure\n* Age at registration ≥ 18 years\n\nExclusion Criteria:\n\n* Nodular-lymphocyte predominant HL (NLPHL) or composite/greyzone lymphoma\n* Lymphoma involving the central nervous system\n* Naïve to treatment with anti-PD1 targeting antibodies'}, 'identificationModule': {'nctId': 'NCT03480334', 'acronym': 'AERN', 'briefTitle': 'Abscopal Effect of Radiotherapy and Nivolumab in Relapsed Hodgkin Lymphoma After Anti-PD1 Therapy', 'organization': {'class': 'OTHER', 'fullName': 'University of Cologne'}, 'officialTitle': 'Abscopal Effect of Radiotherapy and Nivolumab in Relapsed Hodgkin Lymphoma After Anti-PD1 Therapy', 'orgStudyIdInfo': {'id': 'Uni-Koeln 3140'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Arm A', 'description': 'Nivolumab 240 mg i.v. at 2-weekly intervals combined with 20Gy radiotherapy (RT) to a preferably progressive and not pre-irradiated single lesion. Nivolumab will be continued for a maximum of 18 months or until disease progression or unacceptable toxicity.', 'interventionNames': ['Other: Nivolumab plus radiotherapy']}], 'interventions': [{'name': 'Nivolumab plus radiotherapy', 'type': 'OTHER', 'description': 'Nivolumab 240 mg i.v. at 2-weekly intervals combined with 20Gy radiotherapy (RT) to a preferably progressive and not pre-irradiated single lesion. Nivolumab will be continued for a maximum of 18 months or until disease progression or unacceptable toxicity.', 'armGroupLabels': ['Arm A']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Cologne', 'country': 'Germany', 'facility': '1st Department of Medicine, Cologne University Hospital', 'geoPoint': {'lat': 50.93333, 'lon': 6.95}}], 'overallOfficials': [{'name': 'Andreas Engert, Prof.', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'University of Cologne, I. Dept. of Medicine'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'UNDECIDED'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University of Cologne', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Dr.', 'investigatorFullName': 'Dr. Paul Broeckelmann', 'investigatorAffiliation': 'University of Cologne'}}}}