A Study of Nivolumab + Brentuximab Vedotin in Children, Adolescents, and Young Adults With Classic Hodgkin Lymphoma (cHL) After Failure of First Line Therapy, Followed by Brentuximab Vedotin + Bendamustine for Participants With a Suboptimal Response

Study ID
STU 012017-031

Study Sites

  • Children’s Medical Center (Dallas, Plano, Southlake)

Contact
AMANDA RICHARDS
2144566300
AMANDA.RICHARDS@childrens.com

Principal Investigator
Martha Pacheco, M.D.

Official Title

Risk-based, Response-adapted, Phase II Open-label Trial of Nivolumab + Brentuximab Vedotin (N + Bv) for Children, Adolescents, and Young Adults With Relapsed/Refractory (R/R) CD30 + Classic Hodgkin Lymphoma (cHL) After Failure of First-line Therapy, Followed by Brentuximab + Bendamustine (Bv + B) for Participants With a Suboptimal Response (CheckMate 744: CHECKpoint Pathway and Nivolumab Clinical Trial Evaluation)

Brief Overview

The purpose of this study is to determine whether nivolumab + brentuximab vedotin, followed by brentuximab vedotin + bendamustine for participants with a suboptimal response, is safe and effective in the treatment of classic Hodgkin lymphoma (cHL) in children, adolescents, and young adults after failure of first line therapy.

Eligibility

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