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

NCT02038946 | Completed Phase 2 Results FDA Drug

• 2 other identifiers: CA209-1402013-003645-42
• Study Type: interventional
• Target: 116
• Locations: 12 countries
• Sites: 45

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.

Conditions

Lymphoma

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (5)

• Duration of Response (DOR) Based on IRRC Assessments

  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

  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

  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

  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

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

Study Arms (1)

Arm 1: Nivolumab

EXPERIMENTAL

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

Drug: Nivolumab

Interventions

Nivolumab DRUG

Also known as: BMS-936558

Arm 1: Nivolumab

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Bristol-Myers Squibb: lead

Study Sites (45)

Mayo Clinic Arizona

Phoenix, Arizona, 85054, United States

Location

Division Of Hematology & Oncology Ctr. For Health Sciences

Los Angeles, California, 90095, United States

Location

Winship Cancer Institute.

Atlanta, Georgia, 30322, United States

Location

Beth Israel Deaconess Medical Center (BIDMC)

Boston, Massachusetts, 02215, United States

Location

Dana Farber Cancer Institute

Boston, Massachusetts, 02215, United States

Location

Massachusetts General Hospital

Boston, Massachusetts, 02215, United States

Location

Mayo Clinic

Rochester, Minnesota, 55905, United States

Location

Weill Cornell Medical College

New York, New York, 10021, United States

Location

Duke University Medical Center

Durham, North Carolina, 27710, United States

Location

Vanderbilt University Medical Center

Nashville, Tennessee, 37232, United States

Location

MD Anderson Cancer Center

Houston, Texas, 77030, United States

Location

Huntsman Cancer Institute

Salt Lake City, Utah, 84112, United States

Location

Local Institution

Woodville, South Australia, 5011, Australia

Location

Local Institution

Parkville, Victoria, 3050, Australia

Location

Local Institution

B-leuven, 3000, Belgium

Location

Local Institution

Brussels, 1200, Belgium

Location

Local Institution

Ghent, 9000, Belgium

Location

Jewish General Hospital

Montreal, Quebec, H3T 1E2, Canada

Location

CISSS du Bas-Saint-Laurent Hopital Regional de Rimouski

Rimouski, Quebec, G5L 5T1, Canada

Location

Local Institution

Créteil, 94010, France

Location

Local Institution

Montpellier, 34295, France

Location

Local Institution

Pierre-Bénite, 69495, France

Location

Local Institution

Rennes, 35033, France

Location

Universitaetsklinikum Essen

Essen, 45147, Germany

Location

Universitaetsklinikum d. Saarlandes

Homburg, 66424, Germany

Location

Universitaetsklinikum Des Saarlandes

Homburg, 66424, Germany

Location

Local Institution

Regensburg, 93053, Germany

Location

Universitaetsklinikum Ulm

Ulm, 89081, Germany

Location

Local Institution

Bergamo, 24127, Italy

Location

Local Institution

Bologna, 40138, Italy

Location

Local Institution

Milan, 20133, Italy

Location

Local Institution

Napoli, 80131, Italy

Location

Local Institution

Roma, 00161, Italy

Location

Local Institution

Oslo, 0424, Norway

Location

Local Institution

Singapore, 169865, Singapore

Location

Local Institution

Singapore, 308433, Singapore

Location

Hospital Duran I Reynals

Hospitalet Llobregat- Barcelona, 9908, Spain

Location

Local Institution

Madrid, 28009, Spain

Location

Hospital Universitario La Paz

Madrid, 28046, Spain

Location

Local Institution

Salamanca, 37007, Spain

Location

Local Institution

Gothenberg, 413 45, Sweden

Location

Local Institution

Gothenburg, 413 45, Sweden

Location

Local Institution

Southampton, Hampshire, SO16 6YD, United Kingdom

Location

Local Institution

Withington, Manchester, M20 4BX, United Kingdom

Location

Local Institution

Sutton, Surrey, SM2 5PT, United Kingdom

Location

Related Publications (1)

• 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.

  PMID: 32870269 DERIVED

Related Links

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

MeSH Terms

Conditions

Lymphoma

Interventions

Nivolumab

Condition Hierarchy (Ancestors)

Neoplasms by Histologic Type; Neoplasms; Lymphoproliferative Disorders; Lymphatic Diseases; Hemic and Lymphatic Diseases; Immunoproliferative Disorders; Immune System Diseases

Intervention Hierarchy (Ancestors)

Antibodies, Monoclonal, Humanized; Antibodies, Monoclonal; Antibodies; Immunoglobulins; Immunoproteins; Blood Proteins; Proteins; Amino Acids, Peptides, and Proteins; Serum Globulins; Globulins

Results Point of Contact

• Title: Bristol-Myers Squibb Study Director
• Organization: Bristol-Myers Squibb

Clinical.Trials@bms.com

Please Email

Study Officials

• Bristol-Myers Squibb

  Bristol-Myers Squibb

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 15, 2014
• First Posted: January 17, 2014
• Study Start: March 26, 2014
• Primary Completion: May 17, 2017
• Study Completion: December 28, 2020
• Last Updated: January 4, 2022
• Results First Posted: June 12, 2018

Record last verified: 2021-12

Locations

DE (5); SE (2); US (12); IT (5); AU (2); CA (2); SG (2); FR (4); ES (4); BE (3); GB (3); NO (1)