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

ArmDescriptionAssigned Intervention
Experimental
Nivolumab + brentuximab vedotin
  • Biological: Nivolumab
    Specified Dose on Specified Days
    Other names:
    • BMS-936558
    • Opdivo
  • Biological: brentuximab vedotin
    Specified Dose on Specified Days
Experimental
brentuximab vedotin + bendamustine
  • Biological: brentuximab vedotin
    Specified Dose on Specified Days
  • Biological: bendamustine
    Specified Dose on Specified Days

More Details

Status
Active, not recruiting
Sponsor
Bristol-Myers Squibb

Study Contact