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Trial details imported from ClinicalTrials.gov

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




Registration number
NCT03130959
Ethics application status
Date submitted
5/04/2017
Date registered
27/04/2017
Date last updated
11/06/2020

Titles & IDs
Public title
An Investigational Immuno-therapy Study of Nivolumab Monotherapy and Nivolumab in Combination With Ipilimumab in Pediatric Patients With High Grade Primary 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
Cancer 0 0 0 0
Brain
Cancer 0 0 0 0
Children's - Brain

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Other interventions - Nivolumab
Other interventions - Ipilimumab

Experimental: Module A - nivolumab

Experimental: Module B - nivolumab plus ipilimumab


Other interventions: Nivolumab
Specified dose on specified day

Other interventions: Ipilimumab
Specified dose on specified day

Intervention code [1] 0 0
Other interventions
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Incidence of dose limiting toxicity (DLT) - Safety and tolerability
Timepoint [1] 0 0
Approximately 6 weeks
Primary outcome [2] 0 0
Incidence of serious adverse events (SAEs) - Safety and tolerability
Timepoint [2] 0 0
Approximately 6 weeks
Primary outcome [3] 0 0
Incidence of adverse events (AEs) - Safety and tolerability
Timepoint [3] 0 0
Approximately 6 weeks
Primary outcome [4] 0 0
Overall Survival (OS) - Diffuse Intrinsic Pontine Glioma (DIPG).
Timepoint [4] 0 0
Approximately 3 years
Primary outcome [5] 0 0
Progression Free Survival (PFS) - All other tumor types.
Timepoint [5] 0 0
Approximately 2 years
Secondary outcome [1] 0 0
Incidence of AEs - Safety
Timepoint [1] 0 0
Approximately 3 years
Secondary outcome [2] 0 0
Incidence of SAEs - Safety
Timepoint [2] 0 0
Approximately 3 years
Secondary outcome [3] 0 0
Incidence of laboratory abnormalities - Safety
Timepoint [3] 0 0
Approximately 3 years
Secondary outcome [4] 0 0
Progression Free Survival (PFS) - Diffuse Intrinsic Pontine Glioma (DIPG)
Timepoint [4] 0 0
18 months to 24 months
Secondary outcome [5] 0 0
Overall Survival - Diffuse Intrinsic Pontine Glioma (DIPG). Overall Survival at 12 month point (OS(12)).
Timepoint [5] 0 0
Approximately 12 months
Secondary outcome [6] 0 0
Progression Free Survival - High Grade Glioma (HGG), Medulloblastoma, Ependymoma, and other high-grade CNS tumors. At 6 months (PFS(6)).
Timepoint [6] 0 0
Approximately 6 months
Secondary outcome [7] 0 0
Overall Survival (OS) - High Grade Glioma (HGG), Medulloblastoma, Ependymoma, and other high-grade CNS tumors.
Timepoint [7] 0 0
Approximately 3 years
Secondary outcome [8] 0 0
Overall Survival - High Grade Glioma (HGG), Medulloblastoma, Ependymoma. At 12 month point (OS(12)).
Timepoint [8] 0 0
Approximately 12 months

Eligibility
Key inclusion criteria
For more information regarding Bristol-Myers Squibb Clinical Trial participation, please
visit www.BMSStudyConnect.com

- Children and adolescents diagnosed with either:

- Diffuse Intrinsic Pontine Glioma (DIPG), in first-line, after completion of standard
radiotherapy

- High Grade Glioma (HGG), recurrent or progressive

- Medulloblastoma, recurrent or progressive

- Ependymoma, recurrent or progressive

- Other high-grade tumors of the central nervous system, recurrent or progressive

- 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
Gender
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
- Participants with active, known or suspected autoimmune disease

- Participants unable to taper steroids due to ongoing mass effect

- Participants with low-grade gliomas or tumors of unknown malignant potential

- Prior treatment with any drug that targets T cell co-stimulation pathways (such as
checkpoint inhibitors)

Other protocol defined inclusion/exclusion criteria could 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
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)
NSW,QLD,VIC,WA
Recruitment hospital [1] 0 0
Local Institution - Randwick
Recruitment hospital [2] 0 0
Local Institution - Sth Brisbane
Recruitment hospital [3] 0 0
Local Institution - Clayton
Recruitment hospital [4] 0 0
Local Institution - Nedlands
Recruitment hospital [5] 0 0
Local Institution - Parkville
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
6009 - Nedlands
Recruitment postcode(s) [5] 0 0
3052 - Parkville
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
Brazil
State/province [16] 0 0
Sao Paulo
Country [17] 0 0
Canada
State/province [17] 0 0
Ontario
Country [18] 0 0
Canada
State/province [18] 0 0
Quebec
Country [19] 0 0
France
State/province [19] 0 0
Angers
Country [20] 0 0
France
State/province [20] 0 0
Bordeaux Cedex
Country [21] 0 0
France
State/province [21] 0 0
Lille
Country [22] 0 0
France
State/province [22] 0 0
Lyon
Country [23] 0 0
France
State/province [23] 0 0
Marseille
Country [24] 0 0
France
State/province [24] 0 0
Paris
Country [25] 0 0
France
State/province [25] 0 0
Vandoeuvre les Nancy
Country [26] 0 0
France
State/province [26] 0 0
VIillejuif
Country [27] 0 0
Germany
State/province [27] 0 0
Essen
Country [28] 0 0
Germany
State/province [28] 0 0
Hamburg
Country [29] 0 0
Germany
State/province [29] 0 0
Heidelberg
Country [30] 0 0
Germany
State/province [30] 0 0
Wuerzburg
Country [31] 0 0
Hong Kong
State/province [31] 0 0
Hong Kong
Country [32] 0 0
Israel
State/province [32] 0 0
Haifa
Country [33] 0 0
Israel
State/province [33] 0 0
Ramat Gan
Country [34] 0 0
Netherlands
State/province [34] 0 0
Rotterdam
Country [35] 0 0
Netherlands
State/province [35] 0 0
Utrecht
Country [36] 0 0
Norway
State/province [36] 0 0
Oslo
Country [37] 0 0
Poland
State/province [37] 0 0
Warszawa
Country [38] 0 0
Russian Federation
State/province [38] 0 0
Moscow
Country [39] 0 0
Spain
State/province [39] 0 0
Esplugues de Llobregat
Country [40] 0 0
Spain
State/province [40] 0 0
Madrid
Country [41] 0 0
Spain
State/province [41] 0 0
Valencia
Country [42] 0 0
Sweden
State/province [42] 0 0
Solna
Country [43] 0 0
United Kingdom
State/province [43] 0 0
Greater London
Country [44] 0 0
United Kingdom
State/province [44] 0 0
Merseyside
Country [45] 0 0
United Kingdom
State/province [45] 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
The purpose of this study is to determine the safety and effectiveness of nivolumab alone and
in combination with ipilimumab in pediatric patients with high grade primary central nervous
system (CNS) malignancies
Trial website
https://clinicaltrials.gov/show/NCT03130959
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