Pembrolizumab in First-Line Treatment of Advanced-Stage Classical Hodgkin Lymphoma

The primary objective of this trial is to estimate efficacy of the novel regimen. The primary endpoint is the 1-year PFS rate after treatment with one dose of pembrolizumab followed by four to six cycles of chemo-immunotherapy with P-BrECADD, and PET-guided radiotherapy as per standard of care

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Key information

Conditions

Hodgkin Lymphoma Hemic and Lymphatic Diseases Hodgkin Disease Immune System Diseases Immunoproliferative Disorders Lymphatic Diseases Lymphoma Lymphoproliferative Disorders Neoplasms Neoplasms by Histologic Type

Age range

18 year–60 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

1st Department of Medicine, Cologne University Hospital

Cologne, Germany

Who can participate

Healthy volunteers accepted: No

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

Main Inclusion Criteria:

age 18-60
advanced stage classical Hodgkin Lymphoma
no previous treatment for cHL

Main Exclusion Criteria:

Nodular lymphocyte-predominant Hodgkin lymphoma or composite lymphoma
Chemotherapy or radiotherapy in medical history
Prior or concurrent disease that prevents treatment according to protocol

Treatment and study plan

Pembrolizumab

Drug

As induction therapy, all participants will receive one dose of single-agent pembrolizumab (P) followed by two cycles of chemo-immunotherapy consisting of pembrolizumab and BrECADD (P-BrECADD). Response to induction therapy will be measured after 1x P (PET-1) and after 1x P + 2x P-BrECADD (PET-3).

Further systemic treatment is PET-3-guided. Complete metabolic responses will be consolidated with two further cycles of P-BrECADD while participants with a positive PET-3 will receive four further cycles of P-BrECADD. PET-positive lesions after completion of chemo-immunotherapy will be recommended for consolidating radiotherapy according to standard of care.

Primary outcomes

progression free survival

Time frame: 1 year

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 First-Line Treatment of Advanced-Stage Classical Hodgkin Lymphoma

Acronym: Pembro-FLASH

Important dates

Study start: 2025
Primary completion: 2027
Study completion: 2029
First posted: Sep 21, 2023
Registry last updated: Apr 6, 2025

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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