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

NCT06045195 | Not Yet Recruiting Phase 2

• 1 other identifier: Uni-Koeln-4938
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 1

Brief 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

Conditions

Hodgkin Lymphoma

Keywords

advanced stage; first line treatment; PD-1 inhibitor

Outcome Measures

Primary Outcomes (1)

• progression free survival

  1 year

Study Arms (1)

Treatment

EXPERIMENTAL

Pembrolizumab + BrECADD

Drug: Pembrolizumab

Interventions

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.

Treatment

Eligibility Criteria

• Age: 18 Years - 60 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

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

You may not qualify if:

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

Sponsors & Collaborators

• University of Cologne: lead

Study Sites (1)

1st Department of Medicine, Cologne University Hospital

Cologne, Germany

Location

MeSH Terms

Conditions

Hodgkin Disease

Interventions

pembrolizumab

Condition Hierarchy (Ancestors)

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

Study Officials

• Peter Borchmann, Prof.

  1st Department of Medicine, Cologne University Hospital

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Michael Fuchs

CONTACT

+49221478; michael.fuchs@uk-koeln.de

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Prof.

Study Record Dates

• First Submitted: September 12, 2023
• First Posted: September 21, 2023
• Study Start: August 1, 2025
• Primary Completion (Estimated): January 1, 2027
• Study Completion (Estimated): January 1, 2029
• Last Updated: April 6, 2025

Record last verified: 2025-04

Locations

DE (1)