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: Recruiting
Phase: Phase 2
Diagnosis: Lymphoma
NCT ID: NCT02038933 (View complete trial on ClinicalTrials.gov)
DFCI Protocol ID:

 

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

 

Conducting Institutions:
Brigham and Women's Hospital, Dana-Farber Cancer Institute

Overall PI:
Philippe Armand, MD, Dana-Farber Cancer Institute

Site-responsible Investigators:

Contacts:
Dana-Farber Cancer Institute: Kathleen McDermott, kmcdermott@partners.org

Eligibility 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
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