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Clinical trial

Phase II Trial of Pembrolizumab in First-Line Treatment of Advanced-Stage Classical Hodgkin Lymphoma

ID
Name
Uni-Koeln-4938
Description
The aim of the trial is to establish a new regimen with Pembrolizumab and chemotherapy in the first line treatment of patients with advanced stage classical Hodgkin Lymphoma
Trial arms
Trial start
2024-01-01
Estimated PCD
2025-01-01
Trial end
2027-01-01
Status
Not yet recruiting
Phase
Early phase I
Treatment
Pembrolizumab
As induction therapy, all participants will receive one dose of single-agent pembrolizumab (P) followed by two cycles of chemo-immunotherapy consisting of pembrolizumab and an eBEACOPP variant without bleomycin (P-EACOPP). Response to induction therapy will be measured after P-mono (PET-1; only for scientific purposes) and after completion of 1x P and 2x P-EACOPP (PET-3). Further systemic treatment is PET-3-guided. Complete metabolic responses will be consolidated with two cycles of P-EACOPP while participants with a positive PET-3 will receive four cycles of P-EACOPP. PET-positive lesions after completion of chemo-immunotherapy will be recommended for consolidating radiotherapy according to standard of care.
Size
40
Primary endpoint
progression free survival
1 year
Eligibility criteria
Main Inclusion Criteria: * age 18-60 * advanced stage classical Hodgkin Lymphoma * no previous treatment for cHL Main Exclusion Criteria: * Nodular lymphocyte-predominant Hodgkin lymphoma or composite lymphoma * Chemotherapy or radiotherapy in medical history * Prior or concurrent disease that prevents treatment according to protocol
Protocol
{'studyType': 'INTERVENTIONAL', 'phases': ['PHASE2'], 'designInfo': {'allocation': 'NON_RANDOMIZED', 'interventionModel': 'SINGLE_GROUP', 'primaryPurpose': 'TREATMENT', 'maskingInfo': {'masking': 'NONE'}}, 'enrollmentInfo': {'count': 40, 'type': 'ESTIMATED'}}
Updated at
2023-09-21

1 organization

1 product

1 indication

Organization
University of Cologne
Product
Pembrolizumab
Indication
Hodgkin lymphoma