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

• Status: Active, not recruiting
• Trial end date: 2020-06-30
• Target enrollment: 0
• Participant gender: All

Summary

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.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Bristol-Myers Squibb
• Treatments: Antibodies, Monoclonal; Nivolumab

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 CD20 antibody 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 stem cell transplant

• Prior autologous stem cell transplant ≤12 weeks prior to first dose of study drug