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

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Primary Purpose

Status

Completed

Phase

Phase 2

Locations

International

Study Type

Interventional

Intervention

Nivolumab

About this trial

This is an interventional treatment trial for Lymphoma

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Arm 1: Nivolumab

Arm Description

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

Outcomes

Primary Outcome Measures

Overall Response Rate (ORR) as Determined by IRRC

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)

Secondary Outcome Measures

Duration of Response (DOR) Based on IRRC Assessments

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

Complete Remission Rate (CRR) Based on IRRC Assessment

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.

Partial Remission (PR) Rate Based on IRRC Assessment

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)

Progression Free Survival (PFS) Based on IRRC Assessment

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.

Overall Response Rate (ORR) Based on Investigator Assessments

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)

Full Information

NCT ID

NCT02038946

First Posted

January 15, 2014

Last Updated

December 13, 2021

Sponsor

Bristol-Myers Squibb

1. Study Identification

Unique Protocol Identification Number

NCT02038946

Brief Title

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

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

December 2021

Overall Recruitment Status

Completed

Study Start Date

March 26, 2014 (Actual)

Primary Completion Date

May 17, 2017 (Actual)

Study Completion Date

December 28, 2020 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Bristol-Myers Squibb

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Yes

Studies a U.S. FDA-regulated Device Product

No

Data Monitoring Committee

No

5. Study Description

Brief Summary

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Lymphoma

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 2

Interventional Study Model

Single Group Assignment

Masking

None (Open Label)

Allocation

N/A

Enrollment

116 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Arm 1: Nivolumab

Arm Type

Experimental

Arm Description

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

Intervention Type

Drug

Intervention Name(s)

Nivolumab

Other Intervention Name(s)

BMS-936558

Primary Outcome Measure Information:

Title

Overall Response Rate (ORR) as Determined by IRRC

Description

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)

Time Frame

From Week 9 until documented disease progression or study discontinuation (assessed up to June 2017, approximately 38 months)

Secondary Outcome Measure Information:

Title

Duration of Response (DOR) Based on IRRC Assessments

Description

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

Time Frame

From Week 9 until documented disease progression or study discontinuation (assessed up to June 2017, approximately 38 months)

Title

Complete Remission Rate (CRR) Based on IRRC Assessment

Description

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.

Time Frame

From Week 9 until documented disease progression or study discontinuation (assessed up to June 2017, approximately 38 months)

Title

Partial Remission (PR) Rate Based on IRRC Assessment

Description

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)

Time Frame

From Week 9 until documented disease progression or study discontinuation (assessed up to June 2017, approximately 38 months)

Title

Progression Free Survival (PFS) Based on IRRC Assessment

Description

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.

Time Frame

From Week 9 until documented disease progression or study discontinuation (assessed up to June 2017, approximately 38 months)

Title

Overall Response Rate (ORR) Based on Investigator Assessments

Description

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)

Time Frame

From Week 9 until documented disease progression or study discontinuation (assessed up to June 2017, approximately 38 months)

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Accepts Healthy Volunteers

No

Eligibility 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

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Bristol-Myers Squibb

Organizational Affiliation

Bristol-Myers Squibb

Official's Role

Study Director

Facility Information:

Facility Name

Mayo Clinic Arizona

City

Phoenix

State/Province

Arizona

ZIP/Postal Code

85054

Country

United States

Facility Name

Division Of Hematology & Oncology Ctr. For Health Sciences

City

Los Angeles

State/Province

California

ZIP/Postal Code

90095

Country

United States

Facility Name

Winship Cancer Institute.

City

Atlanta

State/Province

Georgia

ZIP/Postal Code

30322

Country

United States

Facility Name

Beth Israel Deaconess Medical Center (BIDMC)

City

Boston

State/Province

Massachusetts

ZIP/Postal Code

02215

Country

United States

Facility Name

Dana Farber Cancer Institute

City

Boston

State/Province

Massachusetts

ZIP/Postal Code

02215

Country

United States

Facility Name

Massachusetts General Hospital

City

Boston

State/Province

Massachusetts

ZIP/Postal Code

02215

Country

United States

Facility Name

Mayo Clinic

City

Rochester

State/Province

Minnesota

ZIP/Postal Code

55905

Country

United States

Facility Name

Weill Cornell Medical College

City

New York

State/Province

New York

ZIP/Postal Code

10021

Country

United States

Facility Name

Duke University Medical Center

City

Durham

State/Province

North Carolina

ZIP/Postal Code

27710

Country

United States

Facility Name

Vanderbilt University Medical Center

City

Nashville

State/Province

Tennessee

ZIP/Postal Code

37232

Country

United States

Facility Name

MD Anderson Cancer Center

City

Houston

State/Province

Texas

ZIP/Postal Code

77030

Country

United States

Facility Name

Huntsman Cancer Institute

City

Salt Lake City

State/Province

Utah

ZIP/Postal Code

84112

Country

United States

Facility Name

Local Institution

City

Woodville

State/Province

South Australia

ZIP/Postal Code

5011

Country

Australia

Facility Name

Local Institution

City

Parkville

State/Province

Victoria

ZIP/Postal Code

3050

Country

Australia

Facility Name

Local Institution

City

B-leuven

ZIP/Postal Code

3000

Country

Belgium

Facility Name

Local Institution

City

Bruxelles

ZIP/Postal Code

1200

Country

Belgium

Facility Name

Local Institution

City

Gent

ZIP/Postal Code

9000

Country

Belgium

Facility Name

Jewish General Hospital

City

Montreal

State/Province

Quebec

ZIP/Postal Code

H3T 1E2

Country

Canada

Facility Name

CISSS du Bas-Saint-Laurent Hopital Regional de Rimouski

City

Rimouski

State/Province

Quebec

ZIP/Postal Code

G5L 5T1

Country

Canada

Facility Name

Local Institution

City

Creteil

ZIP/Postal Code

94010

Country

France

Facility Name

Local Institution

City

Montpellier Cedex 05

ZIP/Postal Code

34295

Country

France

Facility Name

Local Institution

City

Pierre Benite Cedex

ZIP/Postal Code

69495

Country

France

Facility Name

Local Institution

City

Rennes

ZIP/Postal Code

35033

Country

France

Facility Name

Universitaetsklinikum Essen

City

Essen

ZIP/Postal Code

45147

Country

Germany

Facility Name

Universitaetsklinikum d. Saarlandes

City

Homburg

ZIP/Postal Code

66424

Country

Germany

Facility Name

Universitaetsklinikum Des Saarlandes

City

Homburg

ZIP/Postal Code

66424

Country

Germany

Facility Name

Local Institution

City

Regensburg

ZIP/Postal Code

93053

Country

Germany

Facility Name

Universitaetsklinikum Ulm

City

Ulm

ZIP/Postal Code

89081

Country

Germany

Facility Name

Local Institution

City

Bergamo

ZIP/Postal Code

24127

Country

Italy

Facility Name

Local Institution

City

Bologna

ZIP/Postal Code

40138

Country

Italy

Facility Name

Local Institution

City

Milano

ZIP/Postal Code

20133

Country

Italy

Facility Name

Local Institution

City

Napoli

ZIP/Postal Code

80131

Country

Italy

Facility Name

Local Institution

City

Roma

ZIP/Postal Code

00161

Country

Italy

Facility Name

Local Institution

City

Oslo

ZIP/Postal Code

0424

Country

Norway

Facility Name

Local Institution

City

Singapore

ZIP/Postal Code

169865

Country

Singapore

Facility Name

Local Institution

City

Singapore

ZIP/Postal Code

308433

Country

Singapore

Facility Name

Hospital Duran I Reynals

City

Hospitalet Llobregat- Barcelona

ZIP/Postal Code

9908

Country

Spain

Facility Name

Local Institution

City

Madrid

ZIP/Postal Code

28009

Country

Spain

Facility Name

Hospital Universitario La Paz

City

Madrid

ZIP/Postal Code

28046

Country

Spain

Facility Name

Local Institution

City

Salamanca

ZIP/Postal Code

37007

Country

Spain

Facility Name

Local Institution

City

Gothenberg

ZIP/Postal Code

413 45

Country

Sweden

Facility Name

Local Institution

City

Gothenburg

ZIP/Postal Code

413 45

Country

Sweden

Facility Name

Local Institution

City

Southampton

State/Province

Hampshire

ZIP/Postal Code

SO16 6YD

Country

United Kingdom

Facility Name

Local Institution

City

Withington

State/Province

Manchester

ZIP/Postal Code

M20 4BX

Country

United Kingdom

Facility Name

Local Institution

City

Sutton

State/Province

Surrey

ZIP/Postal Code

SM2 5PT

Country

United Kingdom

12. IPD Sharing Statement

Citations:

PubMed Identifier

32870269

Citation

Armand P, Janssens A, Gritti G, Radford J, Timmerman J, Pinto A, Mercadal Vilchez S, Johnson P, Cunningham D, Leonard JP, Rodig SJ, Martin-Regueira P, Sumbul A, Samakoglu S, Tang H, Ansell SM. Efficacy and safety results from CheckMate 140, a phase 2 study of nivolumab for relapsed/refractory follicular lymphoma. Blood. 2021 Feb 4;137(5):637-645. doi: 10.1182/blood.2019004753.

Results Reference

derived

Links:

URL

https://www.bms.com/researchers-and-partners/clinical-trials-and-research.html

Description

BMS Clinical Trial Information

URL

https://www.bmsstudyconnect.com/s/US/English/USenHome

Description

BMS Clinical Trial Patient Recruiting

URL

https://www.fda.gov/Safety/MedWatch/SafetyInformation/default.htm

Description

FDA Safety Alerts and Recalls

Lymphoma

About this trial

Eligibility Criteria

Sites / Locations

Arms of the Study

Arm 1

Outcomes

Primary Outcome Measures

Secondary Outcome Measures

Full Information

1. Study Identification

2. Study Status

3. Sponsor/Collaborators

4. Oversight

5. Study Description

6. Conditions and Keywords

7. Study Design

8. Arms, Groups, and Interventions

10. Eligibility

12. IPD Sharing Statement

Learn more about this trial