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Summary

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

Description

Summary

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.

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

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

  • Local Institution not yet accepting patients
    Oakland, California, 94609, United States
  • Local Institution not yet accepting patients
    Madera, California, 93636, United States
  • Local Institution not yet accepting patients
    Palo Alto, California, 94304, United States
  • Local Institution not yet accepting patients
    Los Angeles, California, 90027, United States
  • Local Institution not yet accepting patients
    Los Angeles, California, 90027, United States
  • Local Institution not yet accepting patients
    Orange, California, 92868, United States
  • Local Institution not yet accepting patients
    Loma Linda, California, 92350, United States
  • Local Institution not yet accepting patients
    Las Vegas, Nevada, 89106, United States

Details

Status
accepting new patients
Start Date
Completion Date
(estimated)
Sponsor
Bristol-Myers Squibb
Links
BMS Clinical Trial Information
FDA Safety Alerts and Recalls
BMS Clinical Trial Patient Recruiting
Investigator Inquiry Form
ID
NCT02927769
Phase
Phase 2
Study Type
Interventional
Last Updated
August 1, 2017
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