Overview

This trial is active, not recruiting.

Condition lymphoma
Treatment nivolumab
Phase phase 2
Target PD-1
Sponsor Bristol-Myers Squibb
Start date March 2014
End date April 2017
Trial size 90 participants
Trial identifier NCT02038946, 2013-003645-42, CA209-140

Summary

The purpose of this study is to assess the clinical benefit of Nivolumab, as measured by independent radiologic review committee (IRRC)-assessed objective response rate (ORR) in subjects with FL lymphoma who have failed therapy with both CD20 antibody and an alkylating agent.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Endpoint classification efficacy study
Intervention model single group assignment
Masking open label
Primary purpose treatment
Arm
(Experimental)
Nivolumab 3 mg/kg injection by Intravenous for every 2 weeks until disease progression or discontinuation due to toxicity
nivolumab BMS-936558

Primary Outcomes

Measure
Overall response rate (ORR) as determined by IRRC
time frame: Approximately up to 24 months

Secondary Outcomes

Measure
Duration of response (DOR) based on IRRC assessments
time frame: Approximately up to 24 months
Complete remission rate (CRR) and duration of CRR based on IRRC assessment
time frame: Approximately up to 24 months
Partial remission (PR) rate and duration of PR based on IRRC assessment
time frame: Approximately up to 24 months
Progression free survival (PFS) based on IRRC assessment
time frame: Approximately up to 24 months
Overall response rate (ORR) based on investigator assessments
time frame: Approximately up to 24 months

Eligibility Criteria

Male or female participants at least 18 years old.

For more information regarding BMS clinical trial participation, please visit www.BMSStudyConnect.com Inclusion Criteria: - Grade 1, 2, or 3a FL without pathologic evidence of transformation - Male and female, ages 18 and above, with relapsed or refractory FL lymphoma after > or =2 prior treatment lines; each of the 2 prior treatment lines must include at least CD20 antibody and/or an alkylating agent - Eastern Cooperative Oncology Group (ECOG) Performance Status (PS) 0-1 Exclusion Criteria: - Known central nervous system lymphoma - History of interstitial lung disease - Subjects with active, known or suspected autoimmune disease - Prior allogeneic stem cell transplant - Prior autologous stem cell transplant ≤12 weeks prior to first dose of study drug

Additional Information

Official title A Single Arm, Open-Label Phase 2 Study of Nivolumab (BMS-936558) in Subjects With Relapsed or Refractory Follicular Lymphoma (FL)
Trial information was received from ClinicalTrials.gov and was last updated in November 2016.
Information provided to ClinicalTrials.gov by Bristol-Myers Squibb.