This trial is active, not recruiting.

Condition lymphoma. non-hodgkin
Treatment nivolumab
Phase phase 2
Target PD-1
Sponsor Bristol-Myers Squibb
Start date February 2014
End date April 2016
Trial size 120 participants
Trial identifier NCT02038933, 2013-003621-28, CA209-139


The purpose of this study is to determine whether Nivolumab is effective in the treatment of DLBCL in patients that have failed or are ineligible for ASCT

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
Nivolumab 3 mg/kg solution intravenously every 2 weeks until progression or unacceptable toxicity
nivolumab BMS-936558

Primary Outcomes

Independent radiologic review committee (IRRC)-assessed objective response rate (ORR)
time frame: Approximately up to 24 months

Secondary Outcomes

Duration of ORR (DOR) based on IRRC assessment
time frame: Approximately up to 24 months
Complete remission rate (CRR) and duration of CR based on IRRC assessment
time frame: Approximately up to 24 months
IRRC-assessed progression free survival (PFS)
time frame: Approximately up to 24 months
Investigator-assessed ORR
time frame: Approximately up to 24 months
PR rate and duration of PR based on IRRC assessment
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: - Confirmation of relapsed or refractory DLBCL or transformed lymphoma (TL) - Eastern Cooperative Oncology Group (ECOG) performance status of 0 -1 - At least one lesion that measures >1.5 cm - Prior therapy and screening lab criteria must be met - Appropriate contraceptive measures must be taken Exclusion Criteria: - Known central nervous system (CNS) lymphoma - History of interstitial lung disease, prior malignancy, active autoimmune disease, positive test for hepatitis B or hepatitis C virus - Prior allogeneic stem cell transplant (SCT), chest radiation ≤ 24 weeks from study drug, ≥1000 mg of Carmustine Bis-chloroethylnitrosourea (BCNU) as part of pre-transplant conditioning regimen, prior treatment with drug targeting T-cell costimulation or immune checkpoint pathways - Women who are breastfeeding or pregnant

Additional Information

Official title A Single-Arm, Open-Label, Phase 2 Study of Nivolumab (BMS-936558) in Subjects With Relapsed or Refractory Diffuse Large B-Cell Lymphoma (DLBCL) After Failure of Autologous Stem Cell Transplant (ASCT) or After Failure of At Least Two Prior Multi-Agent Chemotherapy Regimens in Subjects Who Are Not Candidates for ASCT
Trial information was received from ClinicalTrials.gov and was last updated in October 2016.
Information provided to ClinicalTrials.gov by Bristol-Myers Squibb.