Summary

Eligibility
for people ages 18 years and up (full criteria)
Location
at UCLA
Dates
study started
estimated completion

Description

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.

Official Title

A Single Arm, Open-Label Phase 2 Study of Nivolumab (BMS-936558) in Subjects With Relapsed or Refractory Follicular Lymphoma (FL)

Keywords

Lymphoma Lymphoma, Follicular Nivolumab

Eligibility

For people ages 18 years and up

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

Locations

  • Division Of Hematology & Oncology Ctr. For Health Sciences
    Los Angeles California 90095 United States
  • Mayo Clinic Arizona
    Phoenix Arizona 85054 United States

Details

Status
in progress, not accepting new patients
Start Date
Completion Date
(estimated)
Sponsor
Bristol-Myers Squibb
Links
BMS Clinical Trial Information BMS Clinical Trial Patient Recruiting Investigator Inquiry Form FDA Safety Alerts and Recalls
ID
NCT02038946
Phase
Phase 2
Study Type
Interventional
Last Updated