Ignite Creation Date:
2025-12-24 @ 4:48 PM
Ignite Modification Date:
2025-12-24 @ 4:48 PM
Study NCT ID:
NCT06781450
Status:
RECRUITING
Last Update Posted:
2025-01-30
First Post:
2024-12-03
Is Possible Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Study in Patients With Relapsed/Refractory Primary Mediastinal Lymphoma Treated With Pembrolizumab or Nivolumab in Combination With Brentuximab Vedotin in a Real-life Context
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'RETROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 50}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2022-04-23', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-10', 'completionDateStruct': {'date': '2025-12', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-01-28', 'studyFirstSubmitDate': '2024-12-03', 'studyFirstSubmitQcDate': '2025-01-13', 'lastUpdatePostDateStruct': {'date': '2025-01-30', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2025-01-17', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2025-12', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'overall response rate (ORR)', 'timeFrame': 'at the end of treatment, through study completion, an average of 2 years', 'description': 'The study aims to retrospectively evaluate the efficacy in terms of overall response rate (ORR, the sum of complete response \\[CR\\] and partial response \\[PR\\] rate) of pembrolizumab as a single agent and nivolumab in combination with brentuximab vedotin in patients with Primary Mediastinal B Cell Lymphoma Relapsed/Refractory treated in a real-life setting from November 2020 through November 2021'}], 'secondaryOutcomes': [{'measure': 'Duration of Response (DoR)', 'timeFrame': 'through study completion, an average of 2 years', 'description': 'Duration of Response (DoR)'}, {'measure': 'Progression Free Survival (PFS)', 'timeFrame': 'through study completion, an average of 2 years', 'description': 'Progression Free Survival (PFS)'}, {'measure': 'Overall Survival (OS)', 'timeFrame': 'through study completion, an average of 2 years', 'description': 'Overall Survival (OS)'}, {'measure': 'Disease Free Survival (DFS)', 'timeFrame': 'through study completion, an average of 2 years', 'description': 'Disease Free Survival (DFS)'}, {'measure': 'Best response rate (BRR)', 'timeFrame': 'through study completion, an average of 2 years', 'description': 'Best response rate (BRR)'}, {'measure': 'Incidence of Treatment-Emergent Adverse Events [Safety and Tolerability]', 'timeFrame': 'through study completion, an average of 2 years', 'description': 'safety and tolerability of pembrolizumab as a single agent and nivolumab in combination with brentuximab vedotin'}, {'measure': 'Incidence of Treatment-Emergent Serious Adverse Events [Safety and Tolerability]', 'timeFrame': 'through study completion, an average of 2 years', 'description': 'safety and tolerability of pembrolizumab as a single agent and nivolumab in combination with brentuximab vedotin'}]}, 'oversightModule': {'isUsExport': False, 'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['pembrolizumab', 'nivolumab', 'brentuximab vedotin'], 'conditions': ['Primary Mediastinal B Cell Lymphoma']}, 'descriptionModule': {'briefSummary': 'Observational, Non-Interventional, Retrospective, Multicenter Study Focusing on the Efficacy and Safety of Pembrolizumab Monotherapy and Nivolumab in Combination With Brentuximab Vedotin in Clinical Practice Patients With Primary Mediastinal B Cell Lymphoma Relapsed/Refractory', 'detailedDescription': 'Observational, non-interventional, retrospective, multicentre study focusing on the efficacy and safety of pembrolizumab as monotherapy and nivolumab in combination with brentuximab vedotin in daily clinical practice in patients with Primary Mediastinal B Cell Lymphoma Relapsed/Refractory. The study aims to retrospectively evaluate the efficacy in terms of overall response rate (ORR, sum of complete response rate \\[CR\\] and partial response rate \\[PR\\]) of pembrolizumab as a single agent and nivolumab in combination with brentuximab vedotin in patients with Primary Mediastinal B Cell Lymphoma Relapsed/RefractoryL treated in a real-life setting from November 2020 until November 2021.\n\nSecondary objectives\n\n* To assess efficacy, in terms of:\n* Duration of response (DoR)\n* Progression-free survival (PFS)\n* Overall survival (OS)\n* Disease-free survival (DFS)\n* Best response rate (achieved at any time during treatment)\n* To evaluate the safety and tolerability of pembrolizumab as a single agent and nivolumab in combination with brentuximab vedotin The study will include patients with Primary Mediastinal B Cell Lymphoma Relapsed/Refractory treated with pembrolizumab as a single agent and nivolumab in combination with brentuximab vedotin in a real-life setting from November 2020 until November 2021.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Patients with Primary Mediastinal B Cell Lymphoma Relapsed/Refractory treated with pembrolizumab as a single agent and nivolumab in combination with brentuximab vedotin in a real-life context with till Novembre 2021', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n1. Histologically confirmed diagnosis of Primary Mediastinal B Cell Lymphoma Relapsed/Refractory patients who underwent pembrolizumab as a single agent and nivolumab in combination with brentuximab vedotin in a real-life context with till Novembre 2021\n2. Age ≥ 18 years at enrollment\n3. Signature of written informed consent (where applicable)\n\nExclusion Criteria:\n\n1\\. Primary Mediastinal B Cell Lymphoma Relapsed/Refractory patients who underwent pembrolizumab as a single agent and nivolumab in combination with brentuximab vedotin in a clinical trial context.'}, 'identificationModule': {'nctId': 'NCT06781450', 'acronym': 'PRIMICI', 'briefTitle': 'Study in Patients With Relapsed/Refractory Primary Mediastinal Lymphoma Treated With Pembrolizumab or Nivolumab in Combination With Brentuximab Vedotin in a Real-life Context', 'organization': {'class': 'OTHER', 'fullName': 'IRCCS Azienda Ospedaliero-Universitaria di Bologna'}, 'officialTitle': 'Retrospective Observational Study in Patients With Relapsed / Refractory Primary Mediastinal Lymphoma Treated With Pembrolizumab or Nivolumab in Combination With Brentuximab Vedotin in a Real-life Context', 'orgStudyIdInfo': {'id': 'PRIMICI'}}, 'contactsLocationsModule': {'locations': [{'zip': '40138', 'city': 'Bologna', 'state': 'Bologna', 'status': 'RECRUITING', 'country': 'Italy', 'contacts': [{'name': 'Pier Luigi Zinzani, MD', 'role': 'CONTACT', 'email': 'pierluigi.zinzani@unibo.it', 'phone': '+390512144042'}, {'name': 'Cinzia Pellegrini, MD', 'role': 'CONTACT', 'email': 'cinzia.pellegrini@aosp.bo.it', 'phone': '+390512143680'}, {'name': 'Pier Luigi Zinzani, MD', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'IRCCS Azienda Ospedaliero - Universitaria di Bologna', 'geoPoint': {'lat': 44.49381, 'lon': 11.33875}}, {'zip': '70124', 'city': 'Bari', 'status': 'RECRUITING', 'country': 'Italy', 'contacts': [{'name': 'Pellegrino Musto, MD', 'role': 'CONTACT', 'email': 'pellegrino.musto@uniba.it', 'phone': '+39 0805593471'}, {'name': 'Francesco Gaudio, MD', 'role': 'CONTACT', 'email': 'francesco.gaudio@policlinico.ba.it'}, {'name': 'Pellegrino Musto, MD', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Azienda Ospedaliera Universitaria- POLICLINICO BARI', 'geoPoint': {'lat': 41.12066, 'lon': 16.86982}}, {'zip': '20133', 'city': 'Milan', 'status': 'RECRUITING', 'country': 'Italy', 'contacts': [{'name': 'Paolo Corradini, MD', 'role': 'CONTACT', 'email': 'paolo.corradini@unimi.it', 'phone': '+39 0223902950'}, {'name': 'Anna Guidetti, MD', 'role': 'CONTACT', 'email': 'anna.guidetti@istitutotumori.mi.it', 'phone': '+39 0223902175'}, {'name': 'Paolo Corradini, MD', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Fondazione IRCCS Istituto Nazionale dei Tumori', 'geoPoint': {'lat': 42.78235, 'lon': 12.59836}}], 'centralContacts': [{'name': 'Pier Luigi Zinzani, MD', 'role': 'CONTACT', 'email': 'pierluigi.zinzani@unibo.it', 'phone': '+390512144042'}, {'name': 'Cinzia Pellegrini, MD', 'role': 'CONTACT', 'email': 'cinzia.pellegrini@aosp.bo.it', 'phone': '+390512143680'}], 'overallOfficials': [{'name': 'Pier Luigi Zinzani, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'IRCCS Azienda Ospedaliero-Universitaria di Bologna'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'IRCCS Azienda Ospedaliero-Universitaria di Bologna', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}