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
Rochester, Minn., Phoenix/Scottsdale, Ariz.
Trial status: Open for Enrollment
Why is this study being done?
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
Who is eligible to participate?
For more information regarding BMS clinical trial participation, please visit www.BMSStudyConnect.com
- 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
- 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