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)

Bristol-Myers Squibb (BMS)

Status and phase

Completed

Phase 2

Conditions

Lymphoma. Non-Hodgkin

Treatments

Drug: Nivolumab

Study type

Interventional

Funder types

Industry

Identifiers

NCT02038933

2013-003621-28 (EudraCT Number)

CA209-139

Details and patient eligibility

About

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

Enrollment

121 patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

Inclusion and exclusion 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