Clinical Studies Search

Protocol Summary


Protocol No.
PSCI-17-014
Prinicipal Investigator
Brown, Valerie
Phase
Phase II
Age Group
Both
Scope
National
Secondary Protocol No.
CA209744
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)
Objective
Primary:
R1 (Low Risk) Cohort: To describe event-free survival (EFS) rate at 3 years, as assessed by blinded independent central review (BICR).
R2 (Standard Risk) Cohort: To describe the complete metabolic response (CMR) rate prior to HDCT/ASCT by BICR
Secondary Both:
To assess overall response rate (ORR) (CMR +partial metabolic response [PMR]) using Lugano 2014 criteria of the low risk and standard risk
cohorts following 4 cycles of nivolumab and brentuximab vedotin by BICR.
Applicable Disease Sites
Hodgkin's Lymphoma
Status
Open
Participating Institutions
Hershey Medical Center