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:	Active, not recruiting
Conditions:	Lymphoma
Therapuetic Areas:	Oncology
Healthy:	No
Age Range:	18 - Any
Updated:	10/26/2018
Start Date:	February 10, 2014
End Date:	April 1, 2019

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

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

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

We found this trial at

sites

The Mayo Clinic

Rochester, Minnesota 55905

from

Rochester, MN