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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/show/NCT02038946




Registration number
NCT02038946
Ethics application status
Date submitted
15/01/2014
Date registered
17/01/2014
Date last updated
18/05/2020

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 - 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 subjects 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)
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 - 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
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 - 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.
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 - 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)
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 - 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.
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 - 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)
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
Gender
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
Active, not recruiting
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
Accrual to date
Final
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
United Kingdom
State/province [34] 0 0
Hampshire
Country [35] 0 0
United Kingdom
State/province [35] 0 0
Manchester
Country [36] 0 0
United Kingdom
State/province [36] 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/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

Summary results
Other publications