Tundra Space

Tundra Space

Clinical Research Directory

Browse clinical research sites, groups, and studies.

Back to Studies
NOT YET RECRUITING
NCT06045195
PHASE2

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

Sponsor: University of Cologne

View on ClinicalTrials.gov

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

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

Key Details

Gender

All

Age Range

18 Years - 60 Years

Study Type

INTERVENTIONAL

Enrollment

40

Start Date

2025-08

Completion Date

2029-01

Last Updated

2025-04-06

Healthy Volunteers

No

Interventions

DRUG

Pembrolizumab

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.

Locations (1)

1st Department of Medicine, Cologne University Hospital

Cologne, Germany