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BMS Active Not Yet Recruiting Study icon

Active, Not Recruiting

Trial ID CA209-744  |   NCT02927769

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

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Summary

  • Phase 2
  • Male and Female Gender icon
  • 5-30
    Age Range
  • BMS Active Not Yet Recruiting Study icon
    Active, Not Recruiting

Overview

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.

Key Eligibility Criteria

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

Treatment Options

Study Arms

ASSIGNED INTERVENTION

Study Arms

Experimental: brentuximab vedotin + bendamustine

ASSIGNED INTERVENTION
  • Biological: brentuximab vedotin, bendamustine

Study Arms

Experimental: Nivolumab + brentuximab vedotin

ASSIGNED INTERVENTION
  • Biological: brentuximab vedotin, Nivolumab