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

December 13, 2021 updated by: Bristol-Myers Squibb

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

116

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Australia
    • South Australia
      • Woodville, South Australia, Australia, 5011
        • Local Institution
    • Victoria
      • Parkville, Victoria, Australia, 3050
        • Local Institution
  • Belgium
      • B-leuven, Belgium, 3000
        • Local Institution
      • Bruxelles, Belgium, 1200
        • Local Institution
      • Gent, Belgium, 9000
        • Local Institution
  • Canada
    • Quebec
      • Montreal, Quebec, Canada, H3T 1E2
        • Jewish General Hospital
      • Rimouski, Quebec, Canada, G5L 5T1
        • CISSS du Bas-Saint-Laurent Hopital Regional de Rimouski
  • France
      • Creteil, France, 94010
        • Local Institution
      • Montpellier Cedex 05, France, 34295
        • Local Institution
      • Pierre Benite Cedex, France, 69495
        • Local Institution
      • Rennes, France, 35033
        • Local Institution
  • Germany
      • Essen, Germany, 45147
        • Universitaetsklinikum Essen
      • Homburg, Germany, 66424
        • Universitaetsklinikum des Saarlandes
      • Homburg, Germany, 66424
        • Universitaetsklinikum d. Saarlandes
      • Regensburg, Germany, 93053
        • Local Institution
      • Ulm, Germany, 89081
        • Universitaetsklinikum Ulm
  • Italy
      • Bergamo, Italy, 24127
        • Local Institution
      • Bologna, Italy, 40138
        • Local Institution
      • Milano, Italy, 20133
        • Local Institution
      • Napoli, Italy, 80131
        • Local Institution
      • Roma, Italy, 00161
        • Local Institution
  • Norway
      • Oslo, Norway, 0424
        • Local Institution
  • Singapore
      • Singapore, Singapore, 308433
        • Local Institution
      • Singapore, Singapore, 169865
        • Local Institution
  • Spain
      • Hospitalet Llobregat- Barcelona, Spain, 9908
        • Hospital Duran i Reynals
      • Madrid, Spain, 28046
        • Hospital Universitario La Paz
      • Madrid, Spain, 28009
        • Local Institution
      • Salamanca, Spain, 37007
        • Local Institution
  • Sweden
      • Gothenberg, Sweden, 413 45
        • Local Institution
      • Gothenburg, Sweden, 413 45
        • Local Institution
  • United Kingdom
    • Hampshire
      • Southampton, Hampshire, United Kingdom, SO16 6YD
        • Local Institution
    • Manchester
      • Withington, Manchester, United Kingdom, M20 4BX
        • Local Institution
    • Surrey
      • Sutton, Surrey, United Kingdom, SM2 5PT
        • Local Institution
  • United States
    • Arizona
      • Phoenix, Arizona, United States, 85054
        • Mayo Clinic Arizona
    • California
      • Los Angeles, California, United States, 90095
        • Division Of Hematology & Oncology Ctr. For Health Sciences
    • Georgia
      • Atlanta, Georgia, United States, 30322
        • Winship Cancer Institute.
    • Massachusetts
      • Boston, Massachusetts, United States, 02215
        • Dana Farber Cancer Institute
      • Boston, Massachusetts, United States, 02215
        • Massachusetts General Hospital
      • Boston, Massachusetts, United States, 02215
        • Beth Israel Deaconess Medical Center (BIDMC)
    • Minnesota
      • Rochester, Minnesota, United States, 55905
        • Mayo Clinic
    • New York
      • New York, New York, United States, 10021
        • Weill Cornell Medical College
    • North Carolina
      • Durham, North Carolina, United States, 27710
        • Duke University Medical Center
    • Tennessee
      • Nashville, Tennessee, United States, 37232
        • Vanderbilt University Medical Center
    • Texas
      • Houston, Texas, United States, 77030
        • MD Anderson Cancer Center
    • Utah
      • Salt Lake City, Utah, United States, 84112
        • Huntsman Cancer Institute

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: NA
  • Interventional Model: SINGLE_GROUP
  • Masking: NONE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Arm 1: Nivolumab
Nivolumab 3 mg/kg injection by Intravenous for every 2 weeks until disease progression or discontinuation due to toxicity
Drug: Nivolumab
Other Names:
  • BMS-936558

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Overall Response Rate (ORR) as Determined by IRRC
Time Frame: From Week 9 until documented disease progression or study discontinuation (assessed up to June 2017, approximately 38 months)

ORR is determined by an independent radiologic review committee (IRRC) according to the revised International Working Group Criteria for non-Hodgkin Lymphoma. ORR is defined as the number of participants with a best overall response (BOR) of complete response (CR) or partial response (PR) and expressed as a percentage of all treated participants.

CR=Disappearance of all clinical/radiographic evidence of disease, regression of lymph nodes to normal size, absence of spleen, liver, and bone marrow involvement.

PR=Regression of measurable disease and no new sites; no increase in size of liver or spleen. >=50% decrease in SPD of up to 6 largest dominant masses (index lesions); no increase in size of other nodes (non-index lesions)
From Week 9 until documented disease progression or study discontinuation (assessed up to June 2017, approximately 38 months)

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Duration of Response (DOR) Based on IRRC Assessments
Time Frame: From Week 9 until documented disease progression or study discontinuation (assessed up to June 2017, approximately 38 months)

DOR is defined as the time from first remission (CR or PR) to the date of initial objectively documented progression as determined using the revised International Working Group Criteria for non-Hodgkin Lymphoma, or death due to any cause, whichever occurs first.

CR definition includes the complete disappearance of all evidence of disease, the definition of PR includes at least a 50% decrease in sum of the product of the diameters (SPD) of up to six of the largest dominant nodes or nodal masses, and PD is defined as any new lesion or increase by >50% of previously involved sites from nadir, as described in the IWG response criteria
From Week 9 until documented disease progression or study discontinuation (assessed up to June 2017, approximately 38 months)
Complete Remission Rate (CRR) Based on IRRC Assessment
Time Frame: From Week 9 until documented disease progression or study discontinuation (assessed up to June 2017, approximately 38 months)

CRR is defined as the number of subjects with a BOR of CR according to the revised International Working Group Criteria for non-Hodgkin Lymphoma, divided by the number of treated participants and expressed as a percentage.

CR=Disappearance of all clinical/radiographic evidence of disease, regression of lymph nodes to normal size, absence of spleen, liver, and bone marrow involvement.
From Week 9 until documented disease progression or study discontinuation (assessed up to June 2017, approximately 38 months)
Partial Remission (PR) Rate Based on IRRC Assessment
Time Frame: From Week 9 until documented disease progression or study discontinuation (assessed up to June 2017, approximately 38 months)

PR rate is defined as the number of participants with a best overall response (BOR) of PR according to the 2007 International Working Group (IWG) criteria, based on IRRC assessment, divided by the number of treated participants and expressed as a percentage.

PR=Regression of measurable disease and no new sites; no increase in size of liver or spleen. >=50% decrease in SPD of up to 6 largest dominant masses (index lesions); no increase in size of other nodes (non-index lesions)
From Week 9 until documented disease progression or study discontinuation (assessed up to June 2017, approximately 38 months)
Progression Free Survival (PFS) Based on IRRC Assessment
Time Frame: From Week 9 until documented disease progression or study discontinuation (assessed up to June 2017, approximately 38 months)
PFS was summarized descriptively using the Kaplan-Meier (KM) product-limit method. Median values of PFS, along with the two-sided 95% CIs were calculated using a method based on log-log transformation.
From Week 9 until documented disease progression or study discontinuation (assessed up to June 2017, approximately 38 months)
Overall Response Rate (ORR) Based on Investigator Assessments
Time Frame: From Week 9 until documented disease progression or study discontinuation (assessed up to June 2017, approximately 38 months)

ORR is determined by investigator assessments according to the revised International Working Group Criteria for non-Hodgkin Lymphoma. ORR is defined as the number of subjects with a best overall response (BOR) of complete response (CR) or partial response (PR) and is expressed as a percentage of all treated participants.

CR=Disappearance of all clinical/radiographic evidence of disease, regression of lymph nodes to normal size, absence of spleen, liver, and bone marrow involvement.

PR=Regression of measurable disease and no new sites; no increase in size of liver or spleen. >=50% decrease in SPD of up to 6 largest dominant masses (index lesions); no increase in size of other nodes (non-index lesions)
From Week 9 until documented disease progression or study discontinuation (assessed up to June 2017, approximately 38 months)

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Bristol-Myers Squibb

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

March 26, 2014

Primary Completion (Actual)

May 17, 2017

Study Completion (Actual)

December 28, 2020

Study Registration Dates

First Submitted

January 15, 2014

First Submitted That Met QC Criteria

January 16, 2014

First Posted (Estimate)

January 17, 2014

Study Record Updates

Last Update Posted (Actual)

January 4, 2022

Last Update Submitted That Met QC Criteria

December 13, 2021

Last Verified

December 1, 2021

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CA209-140
  • 2013-003645-42 (EudraCT Number)

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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