AHOD1721: 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)

Why are we doing this research?

PURPOSE:

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.

DETAILED DESCRIPTION:

Primary Outcome Measures:

  • Event Free Survival (EFS) [ Time Frame: Up to 5 years ]
    • Low Risk Group. Based on blinded independent central review (BICR)
  • Complete Metabolic Response (CMR) rate [ Time Frame: Up to 5 years ]
    • Standard Risk Group. This is the rate prior to high-dose chemotherapy followed by autologous stem cell transplant (HDCT/ASCT) based on the blinded independent central review (BICR).
  • Complete Metabolic Response (CMR) rate at any time prior to radiation therapy [ Time Frame: Up to 5 years ]
    • Low Risk Group. The CMR rate is defined as the proportion of all response-evaluable participants who, assessed by the BICR, achieve best response of CMR using Lugano 2014 criteria.

Study Type: Interventional
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None - Open Label

Primary Purpose: Treatment

Who can participate?

AGES ELIGIBLE FOR STUDY: 5 Years to 30 Years

ELIGIBILITY CRITERIA

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

Conditions

  • Lymphoma Hodgkin New Diagnosis
  • Adult - Lymphoma Hodgkin New Diagnosis

Contact

For more information contact:

Cincinnati Children’s Hospital Medical Center
Division of Hematology / Oncology
3333 Burnet Ave.
Cincinnati OH 45229-3039

Phone: 513-636-2799

cancer@cchmc.org