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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/ct2/show/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)
Scientific title
A Single Arm, Open-Label Phase 2 Study of Nivolumab (BMS-936558) in Subjects With Relapsed or Refractory Follicular Lymphoma (FL)
Secondary ID [1] 0 0
2013-003645-42
Secondary ID [2] 0 0
CA209-140
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Lymphoma 0 0
Condition category
Condition code
Cancer 0 0 0 0
Lymphoma (non Hodgkin's lymphoma) - High grade lymphoma
Cancer 0 0 0 0
Lymphoma (non Hodgkin's lymphoma) - Low grade lymphoma

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Treatment: Drugs - Nivolumab

Experimental: Arm 1: Nivolumab - Nivolumab 3 mg/kg injection by Intravenous for every 2 weeks until disease progression or discontinuation due to toxicity


Treatment: Drugs: Nivolumab
Intervention code [1] 0 0
Treatment: Drugs
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Overall Response Rate (ORR) as Determined by IRRC
Timepoint [1] 0 0
From Week 9 until documented disease progression or study discontinuation (assessed up to June 2017, approximately 38 months)
Secondary outcome [1] 0 0
Duration of Response (DOR) Based on IRRC Assessments
Timepoint [1] 0 0
From Week 9 until documented disease progression or study discontinuation (assessed up to June 2017, approximately 38 months)
Secondary outcome [2] 0 0
Complete Remission Rate (CRR) Based on IRRC Assessment
Timepoint [2] 0 0
From Week 9 until documented disease progression or study discontinuation (assessed up to June 2017, approximately 38 months)
Secondary outcome [3] 0 0
Partial Remission (PR) Rate Based on IRRC Assessment
Timepoint [3] 0 0
From Week 9 until documented disease progression or study discontinuation (assessed up to June 2017, approximately 38 months)
Secondary outcome [4] 0 0
Progression Free Survival (PFS) Based on IRRC Assessment
Timepoint [4] 0 0
From Week 9 until documented disease progression or study discontinuation (assessed up to June 2017, approximately 38 months)
Secondary outcome [5] 0 0
Overall Response Rate (ORR) Based on Investigator Assessments
Timepoint [5] 0 0
From Week 9 until documented disease progression or study discontinuation (assessed up to June 2017, approximately 38 months)

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
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
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

Study design
Purpose of the study
Treatment
Allocation to intervention
N/A
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Single group
Other design features
Phase
Phase 2
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
26/03/2014
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
28/12/2020
Sample size
Target
Accrual to date
Final
116
Recruitment in Australia
Recruitment state(s)
SA,VIC
Recruitment hospital [1] 0 0
Local Institution - Woodville
Recruitment hospital [2] 0 0
Local Institution - Parkville
Recruitment postcode(s) [1] 0 0
5011 - Woodville
Recruitment postcode(s) [2] 0 0
3050 - Parkville
Recruitment outside Australia
Country [1] 0 0
United States of America
State/province [1] 0 0
Arizona
Country [2] 0 0
United States of America
State/province [2] 0 0
California
Country [3] 0 0
United States of America
State/province [3] 0 0
Georgia
Country [4] 0 0
United States of America
State/province [4] 0 0
Massachusetts
Country [5] 0 0
United States of America
State/province [5] 0 0
Minnesota
Country [6] 0 0
United States of America
State/province [6] 0 0
New York
Country [7] 0 0
United States of America
State/province [7] 0 0
North Carolina
Country [8] 0 0
United States of America
State/province [8] 0 0
Tennessee
Country [9] 0 0
United States of America
State/province [9] 0 0
Texas
Country [10] 0 0
United States of America
State/province [10] 0 0
Utah
Country [11] 0 0
Belgium
State/province [11] 0 0
B-leuven
Country [12] 0 0
Belgium
State/province [12] 0 0
Bruxelles
Country [13] 0 0
Belgium
State/province [13] 0 0
Gent
Country [14] 0 0
Canada
State/province [14] 0 0
Quebec
Country [15] 0 0
France
State/province [15] 0 0
Creteil
Country [16] 0 0
France
State/province [16] 0 0
Montpellier Cedex 05
Country [17] 0 0
France
State/province [17] 0 0
Pierre Benite Cedex
Country [18] 0 0
France
State/province [18] 0 0
Rennes
Country [19] 0 0
Germany
State/province [19] 0 0
Essen
Country [20] 0 0
Germany
State/province [20] 0 0
Homburg
Country [21] 0 0
Germany
State/province [21] 0 0
Regensburg
Country [22] 0 0
Germany
State/province [22] 0 0
Ulm
Country [23] 0 0
Italy
State/province [23] 0 0
Bergamo
Country [24] 0 0
Italy
State/province [24] 0 0
Bologna
Country [25] 0 0
Italy
State/province [25] 0 0
Milano
Country [26] 0 0
Italy
State/province [26] 0 0
Napoli
Country [27] 0 0
Italy
State/province [27] 0 0
Roma
Country [28] 0 0
Norway
State/province [28] 0 0
Oslo
Country [29] 0 0
Singapore
State/province [29] 0 0
Singapore
Country [30] 0 0
Spain
State/province [30] 0 0
Hospitalet Llobregat- Barcelona
Country [31] 0 0
Spain
State/province [31] 0 0
Madrid
Country [32] 0 0
Spain
State/province [32] 0 0
Salamanca
Country [33] 0 0
Sweden
State/province [33] 0 0
Gothenberg
Country [34] 0 0
Sweden
State/province [34] 0 0
Gothenburg
Country [35] 0 0
United Kingdom
State/province [35] 0 0
Hampshire
Country [36] 0 0
United Kingdom
State/province [36] 0 0
Manchester
Country [37] 0 0
United Kingdom
State/province [37] 0 0
Surrey

Funding & Sponsors
Primary sponsor type
Commercial sector/Industry
Name
Bristol-Myers Squibb
Address
Country

Ethics approval
Ethics application status

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.
Trial website
https://clinicaltrials.gov/ct2/show/NCT02038946
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Bristol-Myers Squibb
Address 0 0
Bristol-Myers Squibb
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for scientific queries