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

a study on Hodgkin's Lymphoma Lymphoma

Summary

for people ages 5-30 (full criteria)
at Oakland, California and other locations
study started
estimated completion:

Description

Summary

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.

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)

Keywords

Hodgkin Disease Nivolumab Bendamustine Hydrochloride Antibodies, Monoclonal brentuximab vedotin bendamustine Nivolumab + brentuximab vedotin brentuximab vedotin + bendamustine

Eligibility

For people ages 5-30

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

Locations

  • Children'S Hospital & Research Center At Oakland accepting new patients
    Oakland California 94609 United States
  • Local Institution withdrawn
    San Francisco California 94143-0106 United States
  • Valley Children's Hospital accepting new patients
    Madera California 93636 United States
  • Local Institution not yet accepting patients
    Palo Alto California 94304 United States

Details

Status
accepting new patients
Start Date
Completion Date
(estimated)
Sponsor
Bristol-Myers Squibb
Links
FDA Safety Alerts and Recalls
BMS Clinical Trial Patient Recruiting
Investigator Inquiry Form
ID
NCT02927769
Phase
Phase 2
Study Type
Interventional
Last Updated
June 4, 2018