Pembrolizumab in Combination With Salvage Chemotherapy for First-relapsed or Refractory Classical Hodgkin Lymphoma

Phase 2

Recruiting

• Conditions: Classical Hodgkin Lymphoma
• Interventions: Drug: Pembrolizumab plus Chemotherapy (ICE or DHAP)

• Registration Number: NCT04838652
• Lead Sponsor: University of Cologne

Brief Summary

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).

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2021-04-06
• Study First Submitted QC: 2021-04-08
• Study First Posted: 2021-04-09
• Study Start: 2024-03-05
• Status Verified: 2024-08
• Last Update Submitted: 2024-08-21
• Last Update Posted: 2024-08-23
• Primary Completion: 2026-05
• Study Completion: 2028-05

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 29

Inclusion Criteria

• Histologically confirmed first relapse of cHL or primary refractory cHL

Exclusion Criteria

• Nodular lymphocyte-predominant Hodgkin lymphoma or composite lymphoma

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Pembrolizumab plus Chemotherapy	Pembrolizumab plus Chemotherapy (ICE or DHAP)	All patients will receive 1 dose of 200 mg pembrolizumab IV as single agent upfront, followed by 2 cycles of IV P-ICE (pembrolizumab, ifosfamide, carboplatin, etoposide) and a PET/CT-based restaging. Following a PET-guided treatment strategy, patients will then receive either another 2 cycles of IV P-ICE in case of a negative PET (i.e., Deauville score 1-3), or 2 to 4 cycles of IV P-DHAP (pembrolizumab, dexamethasone, cytarabine, cisplatin) in case of a positive PET (i.e., Deauville score \> 3). After completion of treatment with P-ICE or P-DHAP, respectively, patients will receive a consolidation therapy with pembrolizumab for another 6 cycles. In case of non-CR after at least 4 cycles of combination therapy (4x P-ICE or 2x P-ICE + 2x P-DHAP), physicians may decide to go for HDCT or an alternative standard of care treatment option.

Primary Outcome Measures

Name	Time	Method
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)

Trial Locations

Locations (1)

1st Department of Medicine, Cologne University Hospital; 🇩🇪 Cologne, Germany