NCT02927769

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

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)

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 72 (actual)
• Sponsor: Bristol-Myers Squibb · Industry
• Sex: All
• Age: 5 Years – 30 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Hodgkin Disease

Interventions

Type	Name	Description
BIOLOGICAL	Nivolumab	Specified Dose on Specified Days
BIOLOGICAL	brentuximab vedotin	Specified Dose on Specified Days
BIOLOGICAL	bendamustine	Specified Dose on Specified Days

Timeline

• Start date: 2017-03-28
• Primary completion: 2024-05-28
• Completion: 2024-05-28
• First posted: 2016-10-07
• Last updated: 2025-02-10
• Results posted: 2025-02-10

Locations

79 sites across 11 countries: United States, Canada, Czechia, France, Germany, Ireland, Italy, Netherlands, Poland, Spain, United Kingdom

Regulatory

• FDA-regulated drug study