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

ConditionClassical Hodgkin Lymphoma

Trial statusRecruiting

Trial phasePhase 2

Trial typeInterventional

Biological sexAll

Age18-65

SponsorUniversity of Cologne

About this trial

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).

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Histologically confirmed first relapse of cHL or primary refractory cHL

Disqualifiers

Nodular lymphocyte-predominant Hodgkin lymphoma or composite lymphoma

Trial design

Design model

Single group

Treatments tested in this trial

Pembrolizumab plus Chemotherapy (ICE or DHAP)
Drug
Pembrolizumab (200mg) alone or in combination with ICE (or DHAP in case of PET positive findings after P-ICE) will be admistered. 6 additional courses of pembrolizumab will be administered after the completion P-ICE or P-DHAP

Treatment groups

29 Participants

are divided into 1 treatment group

Group A: Pembrolizumab plus ChemotherapyExperimental treatment 1 intervention

Trial outcomes

Primary outcomes

Complete Metabolic Response Rate (CMR)

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)

Time frame

after completion of P+chemotherapy, an average of 3 months

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

University of Cologne

Lead sponsor

Source ClinicalTrials.gov

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