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

NCT04838652 — Phase 2, Recruiting, 29 participants, University of Cologne

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Phase II Trial of Pembrolizumab in Combination With Salvage Chemotherapy for First-relapsed or Refractory Classical Hodgkin Lymphoma

Registry	NCT04838652, acronym Pembro-CORE
Status	Recruiting
Phase	Phase 2
Study type	Interventional; na, single group, masking: none, treatment
Enrollment	29 (Estimated)
Sponsor	University of Cologne (Other)
Conditions	Classical Hodgkin Lymphoma
Interventions	Pembrolizumab plus Chemotherapy (ICE or DHAP) (Drug)
Dates	start 2024-03-05, primary completion 2026-05-01 (estimated), completion 2028-05-01 (estimated), first posted 2021-04-09, last updated 2024-08-23
Locations	1 site in Germany

-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).

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+Arms and interventions

Arm	Type	Interventions	Description
Pembrolizumab plus Chemotherapy	Experimental	Drug: 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.

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

+Outcome measures

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)

+Eligibility

Sex: All, ages: 18 Years to 65 Years

Inclusion Criteria:

* Histologically confirmed first relapse of cHL or primary refractory cHL

Exclusion Criteria:

* Nodular lymphocyte-predominant Hodgkin lymphoma or composite lymphoma

+Locations (1)

Facility	City	Country	Status
1st Department of Medicine, Cologne University Hospital	Cologne	Germany	Recruiting

+Investigators

Andreas Engert, Prof., Principal investigator, 1st Department of Medicine, Cologne Universit Hospital