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

• ClinicalTrials.gov Identifier: NCT02038946
• Recruitment Status: Completed
• First Posted: January 17, 2014
• Results First Posted: June 12, 2018
• Last Update Posted: January 4, 2022
• Sponsor: Bristol-Myers Squibb
• Information provided by (Responsible Party): Bristol-Myers Squibb

Tracking Information

• First Submitted Date: January 15, 2014
• First Posted Date: January 17, 2014
• Results First Submitted Date: May 16, 2018
• Results First Posted Date: June 12, 2018
• Last Update Posted Date: January 4, 2022
• Actual Study Start Date: March 26, 2014
• Actual Primary Completion Date: May 17, 2017 (Final data collection date for primary outcome measure)

Current Primary Outcome Measures (submitted: December 13, 2021)

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)

Original Primary Outcome Measures (submitted: January 16, 2014)

Overall response rate (ORR) as determined by IRRC [ Time Frame: Approximately up to 24 months ]

ORR is determined by an IRRC 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)

Current Secondary Outcome Measures (submitted: October 15, 2018)

• 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
• 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.
• 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)
• 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.
• 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)

Original Secondary Outcome Measures (submitted: January 16, 2014)

• The duration of response (DOR) based on IRRC assessments [ Time Frame: Approximately up to 24 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
• The complete remission rate (CRR) based on IRRC assessment [ Time Frame: Approximately up to 24 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 subjects
• The progression free survival (PFS) based on IRRC assessment [ Time Frame: Approximately up to 24 months ]
  PFS is defined as the time from first dosing date to the date of the first documented progression, as determined by an IRRC, or death due to any cause, whichever occurs first
• Overall response rate based on investigator assessments [ Time Frame: Approximately up to 24 months ]

• Current Other Pre-specified Outcome Measures: Not Provided
• Original Other Pre-specified Outcome Measures: Not Provided

Descriptive Information

• 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)
• 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.
• Detailed Description: Not Provided
• Study Type: Interventional
• Study Phase: Phase 2
• Study Design: Allocation: N/A; Intervention Model: Single Group Assignment; Masking: None (Open Label); Primary Purpose: Treatment
• Condition: Lymphoma

Intervention

Drug: Nivolumab

Other Name: BMS-936558

Study Arms

Experimental: Arm 1: Nivolumab

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

Intervention: Drug: Nivolumab

• Publications *: 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.

Recruitment Information

• Recruitment Status: Completed
• Actual Enrollment (submitted: July 11, 2017): 116
• Original Estimated Enrollment (submitted: January 16, 2014): 90
• Actual Study Completion Date: December 28, 2020
• Actual Primary Completion Date: May 17, 2017 (Final data collection date for primary outcome measure)

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

Sex/Gender

• Sexes Eligible for Study: All

• Ages: 18 Years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Contacts: Contact information is only displayed when the study is recruiting subjects
• Listed Location Countries: Australia, Belgium, Canada, France, Germany, Italy, Norway, Singapore, Spain, Sweden, United Kingdom, United States

Administrative Information

• NCT Number: NCT02038946
• Other Study ID Numbers: CA209-140; 2013-003645-42 ( EudraCT Number )
• Has Data Monitoring Committee: No

U.S. FDA-regulated Product

• Studies a U.S. FDA-regulated Drug Product: Yes
• Studies a U.S. FDA-regulated Device Product: No

• IPD Sharing Statement: Not Provided
• Current Responsible Party: Bristol-Myers Squibb
• Original Responsible Party: Same as current
• Current Study Sponsor: Bristol-Myers Squibb
• Original Study Sponsor: Same as current
• Collaborators: Not Provided

Investigators

• Study Director: Bristol-Myers Squibb; Bristol-Myers Squibb

• PRS Account: Bristol-Myers Squibb
• Verification Date: December 2021