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Pembrolizumab in First-Line Treatment of Advanced-Stage Classical Hodgkin Lymphoma
Sponsor: University of Cologne
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
Conditions
Interventions
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