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

Study Results

Results available

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE2

Total Enrollment

116 participants

Study Classification

INTERVENTIONAL

Study Start Date

2014-03-26

Study Completion Date

2020-12-28

Brief Summary

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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.

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Detailed Description

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Conditions

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Lymphoma

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Arm 1: Nivolumab

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

Group Type EXPERIMENTAL

Nivolumab

Intervention Type DRUG

Interventions

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Nivolumab

Intervention Type DRUG

Other Intervention Names

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BMS-936558

Eligibility Criteria

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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

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No