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Clinical Trial VICCHEM13105

Title

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

Principal Investigator(s)

Nishitha Reddy

Details

  • Protocol No. VICCHEM13105
  • Open Date: 04/09/2014
  • Staging: Phase II
  • Age Group: Adults
  • Scope: National
  • Objective: To assess the clinical benefit of nivolumab, as measured by independent radiologic review committee (IRRC) assessed objective response rate (ORR) in subjects with FL who have failed therapy with both rituximab and an alkylating agent.
  • Disease Sites: Lymphoma
  • Therapies: Molecular Targeted Agents / Immunotherapy / Biologics
  • Drugs: Nivolumab (BMS-936558)
  • Participating Institutions: Vanderbilt University
  • National Clinical Trial ID: NCT02038946
  • Secondary Protocol No: CA209140

Description

Patients are being asked to take part in this research study because they have been diagnosed with a type of blood cancer called Follicular Lymphoma (FL). The purpose of this study is to test the effectiveness (how well the drug works), safety and tolerability of an investigational drug called nivolumab (also known as BMS-936558). Nivolumab is an antibody (a type of human protein) that is being tested to see if it will allow the body's immune system to work against tumor cells. This study seeks to examine questions about the nivolumab study drug, such as: -- What effect, good or bad, does nivolumab have on men and women with Follicular Lymphoma (FL) who have failed two prior forms of therapy- -- Does nivolumab help to improve the symptoms of follicular lymphoma (FL)- -- What effect does nivolumab have on the body-s immune response to a tumor, and does the body-s immune response change over the course of the study treatment- Participants in the study, will receive nivolumab by intravenous (IV) infusion, meaning the drug is a solution given through a vein. The infusion usually takes about 1 hour (60 minutes).

Eligibility

Ages Eligible for Study:18 Years and older
Genders Eligible for Study:Both
Accepts Healthy Volunteers:No

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