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
Purpose
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.
Condition
- Hodgkin Disease
Eligibility
- Eligible Ages
- Between 5 Years and 30 Years
- Eligible Genders
- All
- Accepts Healthy Volunteers
- No
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
Study Design
- Phase
- Phase 2
- Study Type
- Interventional
- Allocation
- Non-Randomized
- Intervention Model
- Parallel Assignment
- Primary Purpose
- Treatment
- Masking
- None (Open Label)
Arm Groups
Arm | Description | Assigned Intervention |
---|---|---|
Experimental Nivolumab + brentuximab vedotin |
|
|
Experimental brentuximab vedotin + bendamustine |
|
More Details
- Status
- Active, not recruiting
- Sponsor
- Bristol-Myers Squibb