Clinical trial · Interventional
A Study of Nivolumab Plus Brentuximab Vedotin in Patients Between 5 and 30 Years Old, With Hodgkin's Lymphoma (cHL), Relapsed or Refractory From First Line Treatment
Risk-based, Response-adapted, Phase II Open-label Trial of Nivolumab + Brentuximab Vedotin (N + Bv) for Children, Adolescents, and Young Adults With Relapsed/Refractory (R/R) CD30 + Classic Hodgkin Lymphoma (cHL) After Failure of First-line Therapy, Followed by Brentuximab + Bendamustine (Bv + B) for Participants With a Suboptimal Response (CheckMate 744: CHECKpoint Pathway and Nivolumab Clinical Trial Evaluation)
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
The purpose of this study is to determine whether nivolumab plus brentuximab vedotin (followed by brentuximab vedotin plus bendamustine in patient with suboptimal response) is safe and effective in treating patients with Hodgkin's lymphoma (cHL). Eligible patients are children, adolescents, and young adults relapsed or refractory to first line.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Hodgkin Disease | Hodgkin Lymphoma | ALIAS | 0.90 |
Interventions
Interventions (3)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| bendamustine | Biological | Bendamustine | ALIAS |
| brentuximab vedotin | Biological | Brentuximab Vedotin | ALIAS |
| Nivolumab | Biological | Nivolumab | ALIAS |
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- Nivolumab + brentuximab vedotin
- interventionNames
- Biological: Nivolumab
- Biological: brentuximab vedotin
- type
- EXPERIMENTAL
- label
- brentuximab vedotin + bendamustine
- interventionNames
- Biological: brentuximab vedotin
- Biological: bendamustine
Primary outcomes (3)
- measure
- Complete Metabolic Response (CMR) Rate at Any Time Prior to Radiation Therapy by Blinded Independent Centralized Review (BICR) - Cohort 1
- timeFrame
- From first dose to complete metabolic response or the completion of six cycles of therapy (up to approximately 18 weeks).
- description
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 5 Years
- Maximum age
- 30 Years
Show eligibility criteria text
Inclusion Criteria: * Classic Hodgkin Lymphoma (cHL), relapsed or refractory * Minimal limitation on activities of daily living as measured by Karnofsky ≥ 50 for participants \> 16 years of age or Lansky ≥ 50 for participants ≤ 16 years of age. * One prior anti-cancer therapy that did not work Exclusion Criteria: * Active, known, or suspected autoimmune disease or infection * Active cerebral/meningeal disease related to the underlying malignancy * More than one line of anti-cancer therapy or no treatment at all * Received a stem cell transplant for Hodgkin Lymphoma and/or a solid organ transplant * Prior treatment with any drug that targets T cell co-stimulation pathways (such as checkpoint inhibitors) Other protocol defined inclusion/exclusion criteria apply
References
Publications (2)
- DERIVEDDaw S, Cole PD, Hoppe BS, Hodgson D, Beishuizen A, Garnier N, Buffardi S, Mascarin M, Lissat A, Mauz-Korholz C, Krajewski J, Akyol A, Crowe R, Anderson B, Xu Y, Drachtman RA, Kelly KM, Leblanc T, Harker-Murray P. Transplant-Free Approach in Relapsed Hodgkin Lymphoma in Children, Adolescents, and Young Adults: A Nonrandomized Clinical Trial. JAMA Oncol. 2025 Mar 1;11(3):249-257. doi: 10.1001/jamaoncol.2024.5627. PMID 39745739
- DERIVEDHarker-Murray P, Mauz-Korholz C, Leblanc T, Mascarin M, Michel G, Cooper S, Beishuizen A, Leger KJ, Amoroso L, Buffardi S, Rigaud C, Hoppe BS, Lisano J, Francis S, Sacchi M, Cole PD, Drachtman RA, Kelly KM, Daw S. Nivolumab and brentuximab vedotin with or without bendamustine for R/R Hodgkin lymphoma in children, adolescents, and young adults. Blood. 2023 Apr 27;141(17):2075-2084. doi: 10.1182/blood.2022017118. PMID 36564047