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

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)

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.

Trial Description

Primary Outcome:

  • Event Free Survival (EFS)
  • Complete Metabolic Response (CMR) Rate
Secondary Outcome:
  • Overall Response Rate (ORR)
  • Progression Free Survival Rate (PFSR)
  • Duration of Response (DOR)
  • Incidence of serious and non-serious adverse events of nivolumab (BMS-936558) and brentuximab when given in combination.
  • Incidence of clinically significant abnormalities in general laboratory tests of nivolumab (BMS-936558) and brentuximab when given in combination.
  • Incidence of clinically significant vital sign measurements of nivolumab (BMS-936558) and brentuximab when given in combination.

View this trial on ClinicalTrials.gov

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Resources

Canadian Cancer Society

These resources are provided in partnership with the Canadian Cancer Society