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

Status: Recruiting
Phase:
DFCI Protocol ID: 17-408

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.

Conducting Institutions:

Dana-Farber Cancer Institute, Children's Hospital Boston

Overall PI:

Andrew Place, MD, PhD, Dana Farber Cancer Institute

Site-responsible Investigators:

Contacts:

Dana-Farber Cancer Institute: Childrens Hospital Pediatric Clinical Translation Investigation Program CTIP, ctip@partners.org

Eligibility Criteria

For more information regarding Bristol-Myers Squibb Clinical Trial participation, please
visit www.BMSStudyConnect.com

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 could apply

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