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

NCT04838652 | Recruiting Phase 2

• 1 other identifier: Uni-Koeln-3942
• Study Type: interventional
• Target: 29
• Locations: 1 country
• Sites: 1

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).

Conditions

Classical Hodgkin Lymphoma

Outcome Measures

Primary Outcomes (1)

• 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)

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

Study Arms (1)

Pembrolizumab plus Chemotherapy

EXPERIMENTAL

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.

Drug: Pembrolizumab plus Chemotherapy (ICE or DHAP)

Interventions

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

Pembrolizumab plus Chemotherapy

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Histologically confirmed first relapse of cHL or primary refractory cHL

You may not qualify if:

• Nodular lymphocyte-predominant Hodgkin lymphoma or composite lymphoma

Sponsors & Collaborators

• University of Cologne: lead

Study Sites (1)

1st Department of Medicine, Cologne University Hospital

Cologne, Germany

RECRUITING

MeSH Terms

Interventions

pembrolizumab; Drug Therapy; Ice

Intervention Hierarchy (Ancestors)

Therapeutics; Water; Hydroxides; Alkalies; Inorganic Chemicals; Anions; Ions; Electrolytes; Oxides; Oxygen Compounds; Environment; Ecological and Environmental Phenomena; Biological Phenomena; Weather; Meteorological Concepts; Environment and Public Health

Study Officials

• Andreas Engert, Prof.

  1st Department of Medicine, Cologne Universit Hospital

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Michael Fuchs

CONTACT

+49221478; ghsg@uk-koeln.de

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Prof.

Study Record Dates

• First Submitted: April 6, 2021
• First Posted: April 9, 2021
• Study Start: March 5, 2024
• Primary Completion: May 1, 2026
• Study Completion (Estimated): May 1, 2028
• Last Updated: August 23, 2024

Record last verified: 2024-08

Locations

DE (1)