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Phase II Trial of Pembrolizumab in Combination With Salvage Chemotherapy for First-relapsed or Refractory Classical Hodgkin Lymphoma (Pembro-CORE)
The aim of this trial is to develop an effective and well-tolerated regimen for treatment of r/r cHL by introducing the anti-PD-1 antibody pembrolizumab and adding it to well-established chemotherapy regimens (ICE, DHAP). Synergistic effects of conventional agents with checkpoint inhibition may facilitate a highly effective therapy with limited toxicity, which might eventually substitute the very toxic high-dose chemotherapy (HDCT).
Details
| Lead sponsor | University of Cologne |
|---|---|
| Phase | Phase 2 |
| Status | RECRUITING |
| Enrolment | 29 |
| Start date | 2024-03-05 |
| Completion | 2028-05 |
Conditions
- Classical Hodgkin Lymphoma
Interventions
- Pembrolizumab plus Chemotherapy (ICE or DHAP)
Primary outcomes
- Complete Metabolic Response Rate (CMR) — after completion of P+chemotherapy, an average of 3 months
The proportion of patients with a Deauville score of 1-3 in the centrally reviewed restaging after treatment with 1 x pembrolizumab + 4 cycles of pembrolizumab and chemotherapy combined (4x P-ICE or 2x P-ICE + 2x P-DHAP)
Countries
Germany