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

NCT06045195 — Phase 2, Not yet recruiting, 40 participants, University of Cologne

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

Registry	NCT06045195, acronym Pembro-FLASH
Status	Not yet recruiting
Phase	Phase 2
Study type	Interventional; non randomized, single group, masking: none, treatment
Enrollment	40 (Estimated)
Sponsor	University of Cologne (Other)
Conditions	Hodgkin Lymphoma
Interventions	Pembrolizumab (Drug)
Dates	start 2025-08-01 (estimated), primary completion 2027-01-01 (estimated), completion 2029-01-01 (estimated), first posted 2023-09-21, last updated 2025-04-06
Locations	1 site in Germany

-Summary

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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+Arms and interventions

Arm	Type	Interventions	Description
Treatment	Experimental	Drug: Pembrolizumab	Pembrolizumab + BrECADD

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.

+Outcome measures

Primary outcomes

progression free survival [1 year]

+Eligibility

Sex: All, ages: 18 Years to 60 Years

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

+Locations (1)

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

+Investigators

Peter Borchmann, Prof., Principal investigator, 1st Department of Medicine, Cologne University Hospital