Study of Nivolumab in Patients With Relapsed or Refractory Diffuse Large B-Cell Lymphoma (DLBCL) That Have Either Failed or Are Not Eligible for Autologous Stem Cell Transplant (CheckMate 139)

• Status: Completed
• Trial end date: 2020-10-08
• Target enrollment: 0
• Participant gender: All

Summary

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

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Bristol-Myers Squibb
• Treatments: Antibodies, Monoclonal; Nivolumab

Criteria

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