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 (CheckMate 744)
- Conditions
- MedDRA version: 19.1Level: HLGTClassification code 10025319Term: Lymphomas Hodgkin's diseaseSystem Organ Class: 10005329 - Blood and lymphatic system disordersRelapsed/refractory (R/R) CD30 + classic Hodgkin lymphoma (cHL)Therapeutic area: Diseases [C] - Cancer [C04]
- Registration Number
- EUCTR2016-002347-41-ES
- Lead Sponsor
- Bristol-Myers Squibb International Corporation
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Authorised-recruitment may be ongoing or finished
- Sex
- All
- Target Recruitment
- 80
• 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
Are the trial subjects under 18? yes
Number of subjects for this age range: 28
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 52
F.1.3 Elderly (>=65 years) no
F.1.3.1 Number of subjects for this age range
• 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)
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method