Pembrolizumab in Combination With Salvage Chemotherapy for First-relapsed or Refractory Classical Hodgkin Lymphoma (Pembro-CORE)

August 5, 2022 updated by: Prof. Dr. Andreas Engert, University of Cologne

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

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).

Study Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Anticipated)

29

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • Germany
      • Cologne, Germany
        • 1st Department of Medicine, Cologne University Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 65 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Histologically confirmed first relapse of cHL or primary refractory cHL

Exclusion Criteria:

  • Nodular lymphocyte-predominant Hodgkin lymphoma or composite lymphoma

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Pembrolizumab plus Chemotherapy
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)
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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Complete Metabolic Response Rate (CMR)
Time Frame: 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)
after completion of P+chemotherapy, an average of 3 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Cologne

Investigators

  • Principal Investigator: Andreas Engert, Prof., 1st Department of Medicine, Cologne Universit Hospital

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Anticipated)

December 1, 2022

Primary Completion (Anticipated)

December 1, 2024

Study Completion (Anticipated)

December 1, 2026

Study Registration Dates

First Submitted

April 6, 2021

First Submitted That Met QC Criteria

April 8, 2021

First Posted (Actual)

April 9, 2021

Study Record Updates

Last Update Posted (Actual)

August 8, 2022

Last Update Submitted That Met QC Criteria

August 5, 2022

Last Verified

August 1, 2022

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • Uni-Koeln-3942

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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