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Clinical Trial VICCHEM13106

Title

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

Principal Investigator(s)

Nishitha Reddy

Details

  • Protocol No. VICCHEM13106
  • 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 DLBCL or TL who are refractory or have relapsed following ASCT or after failure of at least one prior multi-agent chemotherapy regimen in ASCT ineligible patients.
  • Disease Sites: Lymphoma
  • Therapies: Molecular Targeted Agents / Immunotherapy / Biologics
  • Drugs: Nivolumab (BMS-936558)
  • Participating Institutions: Vanderbilt University
  • National Clinical Trial ID: NCT02038933
  • Secondary Protocol No: CA209139

Description

Participants are being asked to take part in this study because they have been diagnosed with a type of blood cancer called Diffuse Large B-Cell Lymphoma (DLBCL). 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).

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:
• 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