Trial Review

Technical difficulties have been reported by some users of the search function and is being investigated by technical staff. Thank you for your patience and apologies for any inconvenience caused.

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been endorsed by the ANZCTR. Before participating in a study, talk to your health care provider and refer to this information for consumers
Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/ct2/show/NCT02038933




Registration number
NCT02038933
Ethics application status
Date submitted
15/01/2014
Date registered
17/01/2014
Date last updated
14/10/2021

Titles & IDs
Public title
Study of Nivolumab in Patients With Relapsed or Refractory Diffuse Large B-Cell Lymphoma (DLBCL) That Have Either Failed or Are Not Eligible for Autologous Stem Cell Transplant (CheckMate 139)
Scientific title
A Single-Arm, Open-Label, Phase 2 Study of Nivolumab (BMS-936558) in Subjects With Relapsed or Refractory Diffuse Large B-Cell Lymphoma (DLBCL) After Failure of Autologous Stem Cell Transplant (ASCT) or After Failure of At Least Two Prior Multi-Agent Chemotherapy Regimens in Subjects Who Are Not Candidates for ASCT
Secondary ID [1] 0 0
2013-003621-28
Secondary ID [2] 0 0
CA209-139
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Lymphoma. Non-Hodgkin 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: Nivolumab (3 mg/kg) - Nivolumab 3 mg/kg solution intravenously every 2 weeks until progression or unacceptable toxicity


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

Outcomes
Primary outcome [1] 0 0
Objective Response Rate (ORR) Per Independent Radiologic Review Committee (IRRC) Assessment
Timepoint [1] 0 0
From first dose until date of documented disease progression or subsequent therapy, whichever occurs first (assesed up to April 2016, approximately 25 months)
Secondary outcome [1] 0 0
Duration of Response (DOR)
Timepoint [1] 0 0
From date of first response to the date of documented disease progression or death, whichever occurs first (up to approximately 18 months)
Secondary outcome [2] 0 0
Complete Remission Rate
Timepoint [2] 0 0
From date of first dose to study completion (up to approximately 78 months)
Secondary outcome [3] 0 0
Duration of Complete Remission
Timepoint [3] 0 0
From time of first documentation of CR to the date of initial documented disease progression or death due to any cause, whichever occurs first (up approximately 14 months)
Secondary outcome [4] 0 0
Partial Remission Rate
Timepoint [4] 0 0
From date of first dose to study completion (up to approximately 78 months)
Secondary outcome [5] 0 0
Duration of Partial Remission
Timepoint [5] 0 0
From date of first documentation of PR to date of disease progression or death due to any cause, whichever occurs first (up to approximately 12 months)
Secondary outcome [6] 0 0
Progression Free Survival
Timepoint [6] 0 0
From date of first dose to date of documented disease progression or death due to any cause, whichever occurs first (up to approximately 2 months)
Secondary outcome [7] 0 0
Objective Response Rate (ORR) Per Investigator Assessment
Timepoint [7] 0 0
From first dose until date of documented disease progression or subsequent therapy, whichever occurs first (up to approximately 30 months)

Eligibility
Key inclusion criteria
For more information regarding BMS clinical trial participation, please visit
www.BMSStudyConnect.com



- Confirmation of relapsed or refractory DLBCL or transformed lymphoma (TL)

- Eastern Cooperative Oncology Group (ECOG) performance status of 0 -1

- At least one lesion that measures >1.5 cm

- Prior therapy and screening lab criteria must be met

- Appropriate contraceptive measures must be taken
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 (CNS) lymphoma

- History of interstitial lung disease, prior malignancy, active autoimmune disease,
positive test for hepatitis B or hepatitis C virus

- Prior allogeneic stem cell transplant (SCT), chest radiation = 24 weeks from study
drug, =1000 mg of Carmustine Bis-chloroethylnitrosourea (BCNU) as part of
pre-transplant conditioning regimen, prior treatment with drug targeting T-cell
costimulation or immune checkpoint pathways

- Women who are breastfeeding or pregnant

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
5/03/2014
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
8/10/2020
Sample size
Target
Accrual to date
Final
121
Recruitment in Australia
Recruitment state(s)
NSW,SA,VIC
Recruitment hospital [1] 0 0
Local Institution - Waratah
Recruitment hospital [2] 0 0
Local Institution - Woodville
Recruitment hospital [3] 0 0
Local Institution - Heidelberg
Recruitment postcode(s) [1] 0 0
NSW 2298 - Waratah
Recruitment postcode(s) [2] 0 0
5011 - Woodville
Recruitment postcode(s) [3] 0 0
3084 - Heidelberg
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 Jersey
Country [7] 0 0
United States of America
State/province [7] 0 0
New York
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
Utah
Country [10] 0 0
Belgium
State/province [10] 0 0
B-leuven
Country [11] 0 0
Belgium
State/province [11] 0 0
Bruxelles
Country [12] 0 0
Belgium
State/province [12] 0 0
Gent
Country [13] 0 0
Canada
State/province [13] 0 0
Quebec
Country [14] 0 0
Canada
State/province [14] 0 0
Montreal
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
Erlangen
Country [20] 0 0
Germany
State/province [20] 0 0
Essen
Country [21] 0 0
Germany
State/province [21] 0 0
Homburg
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
Netherlands
State/province [28] 0 0
Amsterdam
Country [29] 0 0
Netherlands
State/province [29] 0 0
Rotterdam
Country [30] 0 0
Netherlands
State/province [30] 0 0
Utrecht
Country [31] 0 0
Singapore
State/province [31] 0 0
Singapore
Country [32] 0 0
Spain
State/province [32] 0 0
Hospitalet Llobregat- Barcelona
Country [33] 0 0
Spain
State/province [33] 0 0
Madrid
Country [34] 0 0
Spain
State/province [34] 0 0
Salamanca
Country [35] 0 0
Sweden
State/province [35] 0 0
Gothenburg
Country [36] 0 0
Sweden
State/province [36] 0 0
Lund
Country [37] 0 0
United Kingdom
State/province [37] 0 0
Hampshire
Country [38] 0 0
United Kingdom
State/province [38] 0 0
Manchester
Country [39] 0 0
United Kingdom
State/province [39] 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 determine whether Nivolumab is effective in the treatment of
DLBCL in patients that have failed or are ineligible for ASCT
Trial website
https://clinicaltrials.gov/ct2/show/NCT02038933
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