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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/NCT03130959




Registration number
NCT03130959
Ethics application status
Date submitted
5/04/2017
Date registered
27/04/2017

Titles & IDs
Public title
A Study to Evaluate the Safety and Efficacy of Nivolumab Monotherapy and Nivolumab in Combination With Ipilimumab in Pediatric Participants With High Grade Primary Central Nervous System (CNS) Malignancies
Scientific title
Phase Ib /II Clinical Trial of Nivolumab Monotherapy and Nivolumab in Combination With Ipilimumab in Pediatric Subjects With High Grade Primary CNS Malignancies
Secondary ID [1] 0 0
2016-004441-82
Secondary ID [2] 0 0
CA209-908
Universal Trial Number (UTN)
Trial acronym
CheckMate 908
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Various Advanced Cancer 0 0
Condition category
Condition code

Intervention/exposure
Study type
Interventional(has expanded access)
Description of intervention(s) / exposure
Treatment: Other - Nivolumab
Treatment: Other - Ipilimumab

Experimental: Module A -

Experimental: Module B -


Treatment: Other: Nivolumab
Specified dose on specified days

Treatment: Other: Ipilimumab
Specified dose on specified days
Intervention code [1] 0 0
Treatment: Other
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Number of Safety Lead-In Participants With Dose Limiting Toxicities (DLTs)
Timepoint [1] 0 0
up to 6 weeks post-dosing
Primary outcome [2] 0 0
Number of Safety Lead-In Participants With Serious Adverse Events (SAEs)
Timepoint [2] 0 0
up to 6 weeks post-dosing
Primary outcome [3] 0 0
Number of Safety Lead-In Participants With Adverse Events (AEs) Leading to Discontinuation
Timepoint [3] 0 0
From first dose to 30 days post-last dose (up to approximately 6 weeks)
Primary outcome [4] 0 0
Overall Survival (OS), Cohort 1 Only
Timepoint [4] 0 0
up to approximately 42 months
Primary outcome [5] 0 0
Progression-Free Survival (PFS), Cohorts 2-4
Timepoint [5] 0 0
up to approximately 42 months
Primary outcome [6] 0 0
Progression-Free Survival (PFS), Cohort 5 Only
Timepoint [6] 0 0
up to approximately 42 months
Secondary outcome [1] 0 0
Progression-Free Survival (PFS), Cohort 1 Only
Timepoint [1] 0 0
From first dose to the date of the first documented tumor progression or death due to any cause (up to approximately 55 months)
Secondary outcome [2] 0 0
Overall Survival at 12 Months (OS12), Cohorts 1-4
Timepoint [2] 0 0
From first dose to up to 12 months after first dose
Secondary outcome [3] 0 0
Progression-Free Survival at 6 Months (PFS6), Cohorts 2-5
Timepoint [3] 0 0
From first dose to up to 6 months after first dose
Secondary outcome [4] 0 0
Overall Survival (OS), Cohorts 2-5
Timepoint [4] 0 0
From first dose to the date of death (up to approximately 55 months)
Secondary outcome [5] 0 0
Number of Treated Participants With Adverse Events (AEs)
Timepoint [5] 0 0
From first dose to 30 days post-last dose (up to approximately an average of 3 months and a maximum of 51 months)
Secondary outcome [6] 0 0
Number of Treated Participants With Serious Adverse Events (SAEs)
Timepoint [6] 0 0
From first dose to 30 days post-last dose (up to approximately an average of 3 months and a maximum of 51 months)
Secondary outcome [7] 0 0
Number of Treated Participants With Drug-Related Adverse Events
Timepoint [7] 0 0
From first dose to 30 days post-last dose (up to approximately an average of 3 months and a maximum of 51 months)
Secondary outcome [8] 0 0
Number of Treated Participants With Adverse Events Leading to Discontinuation
Timepoint [8] 0 0
From first dose to 30 days post-last dose (up to approximately an average of 3 months and a maximum of 51 months)
Secondary outcome [9] 0 0
Number of Treated Participant Deaths
Timepoint [9] 0 0
From first dose to the date of death (up to approximately 55 months)
Secondary outcome [10] 0 0
Number of Treated Participant With Laboratory Abnormalities - Liver
Timepoint [10] 0 0
From first dose to 30 days post-last dose (up to approximately an average of 3 months and a maximum of 51 months)
Secondary outcome [11] 0 0
Number of Treated Participant With Laboratory Abnormalities - Thyroid
Timepoint [11] 0 0
From first dose to 30 days post-last dose (up to approximately an average of 3 months and a maximum of 51 months)

Eligibility
Key inclusion criteria
* Must have received standard of care therapy, and there must be no potentially-curative treatment available, in one of the following cohorts:
* A newly diagnosed Diffuse Intrinsic Pontine Glioma (DIPG) that has been treated with radiation therapy (RT) but no chemotherapy
* A histologically confirmed recurrent or progressive non-brainstem High Grade Glioma (HGG) previously treated with surgical resection and RT
* A histologically confirmed medulloblastoma that has relapsed or is resistant to at least one line of prior therapy including surgery, RT, and chemotherapy
* A histologically confirmed ependymoma that has relapsed or is resistant to at least one line of prior therapy including surgical resection and RT
* A histologically-confirmed high grade CNS malignancy "other than above" which is recurrent or progressive after at least one line of prior therapy
* Lansky play score (LPS) for = 16 years of age or Karnofsky performance scale (KPS) for > 16 years of age assessed within two weeks of enrollment must be >= 60
* A tumor sample must be available for submission to central laboratory (not required for DIPG)
Minimum age
6 Months
Maximum age
21 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
* An active, known, or suspected autoimmune disease
* A concurrent condition requiring systemic treatment with either corticosteroids or other immunosuppressive medications within 14 days of start of study treatment
* Known history of positive test for human immunodeficiency virus (HIV) or known acquired immunodeficiency syndrome (AIDS).

Other protocol defined inclusion/exclusion criteria apply

Study design
Purpose of the study
Treatment
Allocation to intervention
Non-randomised trial
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
Parallel
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
12/06/2017
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
17/01/2022
Sample size
Target
Accrual to date
Final
166
Recruitment in Australia
Recruitment state(s)
NSW,QLD,VIC,WA
Recruitment hospital [1] 0 0
Local Institution - 0022 - Randwick
Recruitment hospital [2] 0 0
Local Institution - 0035 - Sth Brisbane
Recruitment hospital [3] 0 0
Local Institution - Clayton
Recruitment hospital [4] 0 0
Local Institution - 0034 - Parkville
Recruitment hospital [5] 0 0
Local Institution - 0033 - Nedlands
Recruitment postcode(s) [1] 0 0
2031 - Randwick
Recruitment postcode(s) [2] 0 0
4101 - Sth Brisbane
Recruitment postcode(s) [3] 0 0
3168 - Clayton
Recruitment postcode(s) [4] 0 0
3052 - Parkville
Recruitment postcode(s) [5] 0 0
6009 - Nedlands
Recruitment outside Australia
Country [1] 0 0
United States of America
State/province [1] 0 0
California
Country [2] 0 0
United States of America
State/province [2] 0 0
Colorado
Country [3] 0 0
United States of America
State/province [3] 0 0
Florida
Country [4] 0 0
United States of America
State/province [4] 0 0
Illinois
Country [5] 0 0
United States of America
State/province [5] 0 0
Maryland
Country [6] 0 0
United States of America
State/province [6] 0 0
Massachusetts
Country [7] 0 0
United States of America
State/province [7] 0 0
Missouri
Country [8] 0 0
United States of America
State/province [8] 0 0
New York
Country [9] 0 0
United States of America
State/province [9] 0 0
Ohio
Country [10] 0 0
United States of America
State/province [10] 0 0
Pennsylvania
Country [11] 0 0
United States of America
State/province [11] 0 0
South Carolina
Country [12] 0 0
United States of America
State/province [12] 0 0
Tennessee
Country [13] 0 0
United States of America
State/province [13] 0 0
Texas
Country [14] 0 0
Brazil
State/province [14] 0 0
RIO Grande DO SUL
Country [15] 0 0
Brazil
State/province [15] 0 0
Sao Paulo
Country [16] 0 0
Canada
State/province [16] 0 0
Ontario
Country [17] 0 0
Canada
State/province [17] 0 0
Quebec
Country [18] 0 0
France
State/province [18] 0 0
Angers
Country [19] 0 0
France
State/province [19] 0 0
Bordeaux Cedex
Country [20] 0 0
France
State/province [20] 0 0
Lille
Country [21] 0 0
France
State/province [21] 0 0
Lyon
Country [22] 0 0
France
State/province [22] 0 0
Marseille
Country [23] 0 0
France
State/province [23] 0 0
Paris
Country [24] 0 0
France
State/province [24] 0 0
Vandoeuvre les Nancy
Country [25] 0 0
France
State/province [25] 0 0
VIillejuif
Country [26] 0 0
Germany
State/province [26] 0 0
Essen
Country [27] 0 0
Germany
State/province [27] 0 0
Hamburg
Country [28] 0 0
Germany
State/province [28] 0 0
Heidelberg
Country [29] 0 0
Germany
State/province [29] 0 0
Wuerzburg
Country [30] 0 0
Hong Kong
State/province [30] 0 0
Hong Kong
Country [31] 0 0
Israel
State/province [31] 0 0
Haifa
Country [32] 0 0
Israel
State/province [32] 0 0
Ramat Gan
Country [33] 0 0
Netherlands
State/province [33] 0 0
Rotterdam
Country [34] 0 0
Netherlands
State/province [34] 0 0
Utrecht
Country [35] 0 0
Norway
State/province [35] 0 0
Oslo
Country [36] 0 0
Poland
State/province [36] 0 0
Warszawa
Country [37] 0 0
Russian Federation
State/province [37] 0 0
Moscow
Country [38] 0 0
Spain
State/province [38] 0 0
Esplugues de Llobregat
Country [39] 0 0
Spain
State/province [39] 0 0
Madrid
Country [40] 0 0
Spain
State/province [40] 0 0
Valencia
Country [41] 0 0
Sweden
State/province [41] 0 0
Solna
Country [42] 0 0
United Kingdom
State/province [42] 0 0
Greater London
Country [43] 0 0
United Kingdom
State/province [43] 0 0
Merseyside
Country [44] 0 0
United Kingdom
State/province [44] 0 0
Tyne And Wear

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

Ethics approval
Ethics application status

Summary
Brief summary
Trial website
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

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
No/undecided IPD sharing reason/comment


What supporting documents are/will be available?




Results publications and other study-related documents

No documents have been uploaded by study researchers.


Results are available at https://clinicaltrials.gov/study/NCT03130959