Clinical trial NCT02038946: 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
Overall status: COMPLETED
Phase: PHASE2
Conditions: Lymphoma
Lead sponsor: Bristol-Myers Squibb
Sponsor class: INDUSTRY
First posted: 2014-01-17
Enrollment: 116
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.


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

Primary outcomes:
measure: Overall Response Rate (ORR) as Determined by IRRC
timeFrame: From Week 9 until documented disease progression or study discontinuation (assessed up to June 2017, approximately 38 months)
Secondary outcomes:
measure: Duration of Response (DOR) Based on IRRC Assessments
timeFrame: From Week 9 until documented disease progression or study discontinuation (assessed up to June 2017, approximately 38 months)
measure: Complete Remission Rate (CRR) Based on IRRC Assessment
timeFrame: From Week 9 until documented disease progression or study discontinuation (assessed up to June 2017, approximately 38 months)
measure: Partial Remission (PR) Rate Based on IRRC Assessment
timeFrame: From Week 9 until documented disease progression or study discontinuation (assessed up to June 2017, approximately 38 months)
measure: Progression Free Survival (PFS) Based on IRRC Assessment
timeFrame: From Week 9 until documented disease progression or study discontinuation (assessed up to June 2017, approximately 38 months)
measure: Overall Response Rate (ORR) Based on Investigator Assessments
timeFrame: From Week 9 until documented disease progression or study discontinuation (assessed up to June 2017, approximately 38 months)
Other outcomes:
Locations:
city: Phoenix
country: United States
facility: Mayo Clinic Arizona
state: Arizona
city: Los Angeles
country: United States
facility: Division Of Hematology & Oncology Ctr. For Health Sciences
state: California
city: Atlanta
country: United States
facility: Winship Cancer Institute.
state: Georgia
city: Boston
country: United States
facility: Beth Israel Deaconess Medical Center (BIDMC)
state: Massachusetts
city: Boston
country: United States
facility: Dana Farber Cancer Institute
state: Massachusetts
city: Boston
country: United States
facility: Massachusetts General Hospital
state: Massachusetts
city: Rochester
country: United States
facility: Mayo Clinic
state: Minnesota
city: New York
country: United States
facility: Weill Cornell Medical College
state: New York
city: Durham
country: United States
facility: Duke University Medical Center
state: North Carolina
city: Nashville
country: United States
facility: Vanderbilt University Medical Center
state: Tennessee
city: Houston
country: United States
facility: MD Anderson Cancer Center
state: Texas
city: Salt Lake City
country: United States
facility: Huntsman Cancer Institute
state: Utah
city: Woodville
country: Australia
facility: Local Institution
state: South Australia
city: Parkville
country: Australia
facility: Local Institution
state: Victoria
city: B-leuven
country: Belgium
facility: Local Institution
city: Bruxelles
country: Belgium
facility: Local Institution
city: Gent
country: Belgium
facility: Local Institution
city: Montreal
country: Canada
facility: Jewish General Hospital
state: Quebec
city: Rimouski
country: Canada
facility: CISSS du Bas-Saint-Laurent Hopital Regional de Rimouski
state: Quebec
city: Creteil
country: France
facility: Local Institution
city: Montpellier Cedex 05
country: France
facility: Local Institution
city: Pierre Benite Cedex
country: France
facility: Local Institution
city: Rennes
country: France
facility: Local Institution
city: Essen
country: Germany
facility: Universitaetsklinikum Essen
city: Homburg
country: Germany
facility: Universitaetsklinikum d. Saarlandes
city: Homburg
country: Germany
facility: Universitaetsklinikum Des Saarlandes
city: Regensburg
country: Germany
facility: Local Institution
city: Ulm
country: Germany
facility: Universitaetsklinikum Ulm
city: Bergamo
country: Italy
facility: Local Institution
city: Bologna
country: Italy
facility: Local Institution
city: Milano
country: Italy
facility: Local Institution
city: Napoli
country: Italy
facility: Local Institution
city: Roma
country: Italy
facility: Local Institution
city: Oslo
country: Norway
facility: Local Institution
city: Singapore
country: Singapore
facility: Local Institution
city: Singapore
country: Singapore
facility: Local Institution
city: Hospitalet Llobregat- Barcelona
country: Spain
facility: Hospital Duran I Reynals
city: Madrid
country: Spain
facility: Local Institution
city: Madrid
country: Spain
facility: Hospital Universitario La Paz
city: Salamanca
country: Spain
facility: Local Institution
city: Gothenberg
country: Sweden
facility: Local Institution
city: Gothenburg
country: Sweden
facility: Local Institution
city: Southampton
country: United Kingdom
facility: Local Institution
state: Hampshire
city: Withington
country: United Kingdom
facility: Local Institution
state: Manchester
city: Sutton
country: United Kingdom
facility: Local Institution
state: Surrey
Study officials:
affiliation: Bristol-Myers Squibb
name: Bristol-Myers Squibb
role: STUDY_DIRECTOR
References:
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.