Summary

Eligibility
for people ages 5-30 (full criteria)
Location
at UCSF
Dates
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, Brentuximab Vedotin, Bendamustine Hydrochloride, bendamustine, Nivolumab + brentuximab vedotin, brentuximab vedotin + bendamustine

Eligibility

You can join if…

Open to people ages 5-30

  • 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

You CAN'T join if...

  • 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

Locations

  • Children'S Hospital & Research Center At Oakland
    Oakland California 94609 United States
  • Local Institution - 0091
    San Diego California 92109 United States
  • Children'S Hospital Of Orange County
    Orange California 92868 United States
  • Valley Children's Hospital
    Madera California 93636 United States
  • Lucile Packard Children'S Research Hospital/Stanford Univ
    Palo Alto California 94304 United States

Details

Status
in progress, not accepting new patients
Start Date
Completion Date
(estimated)
Sponsor
Bristol-Myers Squibb
Links
BMS Clinical Trial Information BMS Clinical Trial Patient Recruiting FDA Safety Alerts and Recalls
ID
NCT02927769
Phase
Phase 2 research study
Study Type
Interventional
Participants
About 72 people participating
Last Updated