Study of Nivolumab in Subjects With Relapsed or Refractory Follicular Lymphoma (FL) (CheckMate 140)

Status: Recruiting
Phase: Phase 2
Diagnosis: Lymphoma
NCT ID: NCT02038946 (View complete trial on ClinicalTrials.gov)
DFCI Protocol ID: 14-159

 

The purpose of this study is to assess the clinical benefit of Nivolumab, as measured by independent radiologic review committee (IRRC)-assessed objective response rate (ORR) in subjects with FL lymphoma who have failed therapy with both CD20 antibody and an alkylating agent.

 

Conducting Institutions:
Dana-Farber Cancer Institute, Brigham and Women's Hospital, Beth-Israel Deaconess Medical Center, Massachusetts General Hospital

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

Site-responsible Investigators:
Jeffery Barnes, MD, Dana Farber Cancer Institute
Robin Joyce, MD, Beth Israel Deaconess Medical Center

Contacts:
Dana-Farber Cancer Institute: Kathleen McDermott, kmcdermott@partners.org
Massachusetts General Hospital: Cancer Trials Call Center, 877-789-6100
Beth-Israel Deaconess Medical Center: Cancer Trials Call Center, 617-667-3060

Eligibility Criteria

For more information regarding BMS clinical trial participation, please visit www.BMSStudyConnect.com Inclusion Criteria: - Grade 1, 2, or 3a FL without pathologic evidence of transformation - Male and female, ages 18 and above, with relapsed or refractory FL lymphoma after > or = 2 prior treatment lines; each of the 2 prior treatment lines must include at least Rituximab and/or an Alkylating agent Eastern Cooperative Oncology Group (ECOG) Performance Status (PS) 0-1 Exclusion Criteria: - Known central nervous system lymphoma - History of interstitial lung disease - Subjects with active, known or suspected autoimmune disease - Prior allogeneic or autologous stem cell transplant
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