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NCT Number: NCT04838652

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).

Recruiting

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Key information

Conditions

Classical Hodgkin Lymphoma

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

1st Department of Medicine, Cologne University Hospital

Cologne, Germany

Location status: Recruiting

Location contact

Michael Fuchs

CONTACT

[email protected]

+49221478 ext. 88160

Peter Borchmann, MD

PRINCIPAL_INVESTIGATOR

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Histologically confirmed first relapse of cHL or primary refractory cHL

Exclusion criteria

  • Nodular lymphocyte-predominant Hodgkin lymphoma or composite lymphoma

Treatment and study plan

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

Primary outcomes

  1. 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)

Study contacts

Contact information is provided by the study sponsor or research team.

Michael Fuchs

CONTACT

[email protected]

+49221478 ext. 88160

Sponsors and collaborators

Lead sponsor

University of Cologne

Other

Registry information

Official study title

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

Acronym: Pembro-CORE

Important dates

Study start
2024
Primary completion
2026
Study completion
2028
First posted
Apr 9, 2021
Registry last updated
Aug 23, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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