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Trial details imported from ClinicalTrials.gov
For full trial details, please see the original record at
https://clinicaltrials.gov/study/NCT02038946
Registration number
NCT02038946
Ethics application status
Date submitted
15/01/2014
Date registered
17/01/2014
Date last updated
4/01/2022
Titles & IDs
Public title
Study of Nivolumab in Subjects With Relapsed or Refractory Follicular Lymphoma (FL) (CheckMate 140)
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Scientific title
A Single Arm, Open-Label Phase 2 Study of Nivolumab (BMS-936558) in Subjects With Relapsed or Refractory Follicular Lymphoma (FL)
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Secondary ID [1]
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2013-003645-42
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Secondary ID [2]
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CA209-140
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Universal Trial Number (UTN)
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Trial acronym
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Linked study record
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Health condition
Health condition(s) or problem(s) studied:
Lymphoma
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Condition category
Condition code
Cancer
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Lymphoma (non Hodgkin's lymphoma) - High grade lymphoma
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Cancer
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Lymphoma (non Hodgkin's lymphoma) - Low grade lymphoma
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Intervention/exposure
Study type
Interventional
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Description of intervention(s) / exposure
Experimental: Arm 1: Nivolumab - Nivolumab 3 mg/kg injection by Intravenous for every 2 weeks until disease progression or discontinuation due to toxicity
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Comparator / control treatment
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Control group
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Outcomes
Primary outcome [1]
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Overall Response Rate (ORR) as Determined by IRRC
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Assessment method [1]
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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)
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Timepoint [1]
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From Week 9 until documented disease progression or study discontinuation (assessed up to June 2017, approximately 38 months)
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Secondary outcome [1]
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Duration of Response (DOR) Based on IRRC Assessments
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Assessment method [1]
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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
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Timepoint [1]
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From Week 9 until documented disease progression or study discontinuation (assessed up to June 2017, approximately 38 months)
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Secondary outcome [2]
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Complete Remission Rate (CRR) Based on IRRC Assessment
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Assessment method [2]
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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.
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Timepoint [2]
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From Week 9 until documented disease progression or study discontinuation (assessed up to June 2017, approximately 38 months)
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Secondary outcome [3]
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Partial Remission (PR) Rate Based on IRRC Assessment
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Assessment method [3]
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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)
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Timepoint [3]
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From Week 9 until documented disease progression or study discontinuation (assessed up to June 2017, approximately 38 months)
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Secondary outcome [4]
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Progression Free Survival (PFS) Based on IRRC Assessment
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Assessment method [4]
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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.
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Timepoint [4]
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From Week 9 until documented disease progression or study discontinuation (assessed up to June 2017, approximately 38 months)
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Secondary outcome [5]
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Overall Response Rate (ORR) Based on Investigator Assessments
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Assessment method [5]
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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)
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Timepoint [5]
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From Week 9 until documented disease progression or study discontinuation (assessed up to June 2017, approximately 38 months)
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Eligibility
Key inclusion criteria
For more information regarding BMS clinical trial participation, please visit www.BMSStudyConnect.com
* 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
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Minimum age
18
Years
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Maximum age
No limit
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Sex
Both males and females
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Can healthy volunteers participate?
No
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Key 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
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Study design
Purpose of the study
Treatment
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Allocation to intervention
NA
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Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
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Methods used to generate the sequence in which subjects will be randomised (sequence generation)
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Masking / blinding
Open (masking not used)
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Who is / are masked / blinded?
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Intervention assignment
Single group
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Other design features
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Phase
Phase 2
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Type of endpoint/s
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Statistical methods / analysis
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Recruitment
Recruitment status
Completed
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Data analysis
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Reason for early stopping/withdrawal
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Other reasons
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Date of first participant enrolment
Anticipated
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Actual
26/03/2014
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Date of last participant enrolment
Anticipated
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Actual
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Date of last data collection
Anticipated
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Actual
28/12/2020
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Sample size
Target
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Accrual to date
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Final
116
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Recruitment in Australia
Recruitment state(s)
SA,VIC
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Recruitment hospital [1]
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Local Institution - Woodville
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Recruitment hospital [2]
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Local Institution - Parkville
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Recruitment postcode(s) [1]
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5011 - Woodville
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Recruitment postcode(s) [2]
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3050 - Parkville
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Recruitment outside Australia
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United States of America
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Arizona
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California
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Georgia
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Massachusetts
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New York
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North Carolina
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B-leuven
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Bruxelles
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Gent
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Creteil
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France
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Montpellier Cedex 05
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France
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Pierre Benite Cedex
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France
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Rennes
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Germany
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Essen
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Germany
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Homburg
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Germany
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Germany
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Ulm
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Italy
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Italy
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Roma
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Oslo
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Singapore
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Spain
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Hospitalet Llobregat- Barcelona
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Spain
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Madrid
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Spain
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Salamanca
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Gothenberg
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Gothenburg
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Hampshire
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Manchester
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United Kingdom
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Surrey
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Funding & Sponsors
Primary sponsor type
Commercial sector/industry
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Name
Bristol-Myers Squibb
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Address
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Ethics approval
Ethics application status
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Summary
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.
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Trial website
https://clinicaltrials.gov/study/NCT02038946
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Trial related presentations / 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.
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Public notes
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Contacts
Principal investigator
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Bristol-Myers Squibb
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Address
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Bristol-Myers Squibb
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Contact person for scientific queries
No information has been provided regarding IPD availability
What supporting documents are/will be available?
No Supporting Document Provided
Type
Other Details
Attachment
Study protocol
https://cdn.clinicaltrials.gov/large-docs/46/NCT02038946/Prot_002.pdf
Statistical analysis plan
https://cdn.clinicaltrials.gov/large-docs/46/NCT02038946/SAP_001.pdf
Results publications and other study-related documents
No documents have been uploaded by study researchers.
Results are available at
https://clinicaltrials.gov/study/NCT02038946
Download to PDF