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

Bristol-Myers Squibb (BMS)

Status and phase: Completed; Phase 2

Conditions: Lymphoma

Treatments: Drug: Nivolumab

Study type: Interventional

Funder types: Industry

Identifiers

NCT02038946

CA209-140

2013-003645-42 (EudraCT Number)

Details and patient eligibility

About

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.

Enrollment: 116 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion 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

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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116 participants in 1 patient group

Arm 1: Nivolumab

Experimental group

Description:

Nivolumab 3 mg/kg injection by Intravenous for every 2 weeks until disease progression or discontinuation due to toxicity

Treatment:

Drug: Nivolumab