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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) | Clinical Trials | Clareo Health

COMPLETEDPHASE2

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)

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

NCT02038933•Bristol-Myers Squibb

View on ClinicalTrials.gov

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

Eligibility

Age

18 - No limit years

Sex

ALL

Healthy Volunteers

Inclusion Criteria

•For more information regarding BMS clinical trial participation, please visit www.BMSStudyConnect.com
•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

Locations (46)

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

Key Dates

Start Date

March 5, 2014

Primary Completion Date

April 8, 2016

Completion Date

October 8, 2020

Last Updated

October 14, 2021

Enrollment

121

ACTUAL participants

Conditions

Lymphoma. Non-Hodgkin

Interventions

Nivolumab

DRUG