NCT03138499
Terminated
Phase 3
Randomized, Open-label, Phase 3 Trial of Nivolumab Plus Brentuximab Vedotin Versus Brentuximab Vedotin Alone in Participants With Relapsed Refractory or Ineligible for Autologous Stem Cell Transplant (ASCT) Advanced Stage Classical Hodgkin Lymphoma (CheckMate 812: CHECKpoint Pathway and nivoluMAb Clinical Trial Evaluation 812)
ConditionsHodgkin's Disease
Overview
- Phase
- Phase 3
- Intervention
- Not specified
- Conditions
- Hodgkin's Disease
- Sponsor
- Bristol-Myers Squibb
- Enrollment
- 23
- Locations
- 20
- Primary Endpoint
- Progression Free Survival (PFS)
- Status
- Terminated
- Last Updated
- 2 years ago
Overview
Brief Summary
The purpose of this study is to determine whether an investigational immuno-therapy combination, nivolumab with Brentuximab vedotin compared to Brentuximab vedotin alone is safe and effective in the treatment of relapsed and refractory Classical Hodgkin Lymphoma. The participants of this trial will comprise of patients who have relapsed or did not respond to treatment and are not eligible for stem cell transplant
Investigators
Eligibility Criteria
Inclusion Criteria
- Not provided
Exclusion Criteria
- Not provided
Outcomes
Primary Outcomes
Progression Free Survival (PFS)
Time Frame: From randomization to date of death, or disease progression (up to approximately 45 months)
Progression Free Survival (PFS) is defined as time from date of randomization to death, or disease progression per investigator assessment estimated using the Kaplan-Meier (KM) product-limit method.
Secondary Outcomes
- Objective Response Rate (ORR)(From randomization up to approximately 45 months)
- Overall Survival (OS)(From randomization to the date of death (up to approximately 3 years 7 months))
- Complete Response Rate (CRR):(From randomization up to approximately 45 months)
- Duration of Response (DOR)(From randomization to date of documented progression or death (up to approximately 45 months))
- Duration of Complete Response (DOCR)(From randomization to date of documented progression or death (up to approximately 45 months))
Study Sites (20)
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