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

Lymphoma Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02038946
• Other study ID #: CA209-140
• Secondary ID: 2013-003645-42
• Status: Completed
• Phase: Phase 2
• Start date: March 26, 2014
• Est. completion date: December 28, 2020

Study information

• Verified date: December 2021
• Source: Bristol-Myers Squibb
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 116
• Est. completion date: December 28, 2020
• Est. primary completion date: May 17, 2017
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Lymphoma
• Lymphoma, Follicular

Intervention

Drug:
• Nivolumab

Locations

Country	Name	City	State
Australia	Local Institution	Parkville	Victoria
Australia	Local Institution	Woodville	South Australia
Belgium	Local Institution	B-leuven
Belgium	Local Institution	Bruxelles
Belgium	Local Institution	Gent
Canada	Jewish General Hospital	Montreal	Quebec
Canada	CISSS du Bas-Saint-Laurent Hopital Regional de Rimouski	Rimouski	Quebec
France	Local Institution	Creteil
France	Local Institution	Montpellier Cedex 05
France	Local Institution	Pierre Benite Cedex
France	Local Institution	Rennes
Germany	Universitaetsklinikum Essen	Essen
Germany	Universitaetsklinikum d. Saarlandes	Homburg
Germany	Universitaetsklinikum Des Saarlandes	Homburg
Germany	Local Institution	Regensburg
Germany	Universitaetsklinikum Ulm	Ulm
Italy	Local Institution	Bergamo
Italy	Local Institution	Bologna
Italy	Local Institution	Milano
Italy	Local Institution	Napoli
Italy	Local Institution	Roma
Norway	Local Institution	Oslo
Singapore	Local Institution	Singapore
Singapore	Local Institution	Singapore
Spain	Hospital Duran I Reynals	Hospitalet Llobregat- Barcelona
Spain	Hospital Universitario La Paz	Madrid
Spain	Local Institution	Madrid
Spain	Local Institution	Salamanca
Sweden	Local Institution	Gothenberg
Sweden	Local Institution	Gothenburg
United Kingdom	Local Institution	Southampton	Hampshire
United Kingdom	Local Institution	Sutton	Surrey
United Kingdom	Local Institution	Withington	Manchester
United States	Winship Cancer Institute.	Atlanta	Georgia
United States	Beth Israel Deaconess Medical Center (BIDMC)	Boston	Massachusetts
United States	Dana Farber Cancer Institute	Boston	Massachusetts
United States	Massachusetts General Hospital	Boston	Massachusetts
United States	Duke University Medical Center	Durham	North Carolina
United States	MD Anderson Cancer Center	Houston	Texas
United States	Division Of Hematology & Oncology Ctr. For Health Sciences	Los Angeles	California
United States	Vanderbilt University Medical Center	Nashville	Tennessee
United States	Weill Cornell Medical College	New York	New York
United States	Mayo Clinic Arizona	Phoenix	Arizona
United States	Mayo Clinic	Rochester	Minnesota
United States	Huntsman Cancer Institute	Salt Lake City	Utah

Sponsors (1)

Lead Sponsor	Collaborator
Bristol-Myers Squibb

Countries where clinical trial is conducted

United States,  Australia,  Belgium,  Canada,  France,  Germany,  Italy,  Norway,  Singapore,  Spain,  Sweden,  United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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)	From Week 9 until documented disease progression or study discontinuation (assessed up to June 2017, approximately 38 months)
Secondary	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	From Week 9 until documented disease progression or study discontinuation (assessed up to June 2017, approximately 38 months)
Secondary	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.	From Week 9 until documented disease progression or study discontinuation (assessed up to June 2017, approximately 38 months)
Secondary	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)	From Week 9 until documented disease progression or study discontinuation (assessed up to June 2017, approximately 38 months)
Secondary	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.	From Week 9 until documented disease progression or study discontinuation (assessed up to June 2017, approximately 38 months)
Secondary	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)	From Week 9 until documented disease progression or study discontinuation (assessed up to June 2017, approximately 38 months)

External Links

•   BMS Clinical Trial Information
•   BMS Clinical Trial Patient Recruiting
•   FDA Safety Alerts and Recalls