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 (CheckMate 744)

Bristol-Myers Squibb (BMS)

Status and phase

Completed

Phase 2

Conditions

Hodgkin Disease

Treatments

Biological: Nivolumab

Biological: brentuximab vedotin

Biological: bendamustine

Study type

Interventional

Funder types

Industry

Identifiers

NCT02927769

CA209-744

2016-002347-41 (EudraCT Number)

Details and patient eligibility

About

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.

Enrollment

72 patients

Sex

All

Ages

5 to 30 years old

Volunteers

No Healthy Volunteers

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