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)

Completed · Phase 2

Conditions studied: Lymphoma. Non-Hodgkin

In brief

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

Key facts

Study ID

NCT02038933

Run by

Bristol-Myers Squibb

People needed

121

Starts

2014-03-05

Expected to finish

2020-10-08

Last updated by the study team

2021-10-14

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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

You may not qualify if…

• 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

Where it is running

• Mayo Clinic Arizona — Phoenix, Arizona, United States
• Division Of Hematology & Oncology Ctr. For Health Sciences — Los Angeles, California, United States
• Winship Cancer Center — Atlanta, Georgia, United States
• Dana Farber Cancer Institute — Boston, Massachusetts, United States
• Mayo Clinic — Rochester, Minnesota, United States
• John Theurer Cancer Center at Hackensack University Medical Center — Hackensack, New Jersey, United States
• Columbia University Medical Center (Cumc) — New York, New York, United States
• Weill Cornell Medical College — New York, New York, United States
• Vanderbilt-Ingram Cancer Center — Nashville, Tennessee, United States
• Huntsman Cancer Institute — Salt Lake City, Utah, United States
• Local Institution — Waratah, New South Wales, Australia
• Local Institution — Woodville, South Australia, Australia
• Local Institution — Heidelberg, Victoria, Australia
• Local Institution — B-leuven, Belgium
• Local Institution — Brussels, Belgium
• Local Institution — Ghent, Belgium
• Local Institution — Montreal, Quebec, Canada
• Local Institution — Montreal, Canada
• Local Institution — Créteil, France
• Hopital Saint Eloi — Montpellier, France
• Local Institution — Pierre-Bénite, France
• Local Institution — Rennes, France
• Local Institution — Erlangen, Germany
• Local Institution — Essen, Germany
• Local Institution — Homburg, Germany

Full record on ClinicalTrials.gov

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