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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/NCT03130959
Registration number
NCT03130959
Ethics application status
Date submitted
5/04/2017
Date registered
27/04/2017
Date last updated
9/08/2022
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
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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
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Secondary ID [1]
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2016-004441-82
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Secondary ID [2]
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CA209-908
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Universal Trial Number (UTN)
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Trial acronym
CheckMate 908
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Linked study record
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Health condition
Health condition(s) or problem(s) studied:
Various Advanced Cancer
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0
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Condition category
Condition code
Intervention/exposure
Study type
Interventional(has expanded access)
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Description of intervention(s) / exposure
Other interventions - Nivolumab
Other interventions - Ipilimumab
Experimental: Module A -
Experimental: Module B -
Other interventions: Nivolumab
Specified dose on specified days
Other interventions: Ipilimumab
Specified dose on specified days
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Intervention code [1]
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Other interventions
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Comparator / control treatment
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Control group
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Outcomes
Primary outcome [1]
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Number of Safety Lead-In Participants With Dose Limiting Toxicities (DLTs)
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Assessment method [1]
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A dose-limiting toxicity (DLT) is defined as a drug-related AE occurring in the first 6 weeks of study treatment. A participant was considered evaluable for a DLT if study treatment was delayed > 2 weeks or was discontinued due to a related Adverse Event (AE), or if planned study treatment (3 doses of nivolumab in Module A, 2 doses of nivolumab plus ipilimumab in Module B) was administered and safety evaluation after 6 weeks on study is available to the study steering committee (SSC).
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Timepoint [1]
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up to 6 weeks post-dosing
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Primary outcome [2]
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Number of Safety Lead-In Participants With Serious Adverse Events (SAEs)
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Assessment method [2]
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The number of Safety Lead-In Participants who experienced a Serious Adverse Event (SAE) during the course of the study.
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Timepoint [2]
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up to 6 weeks post-dosing
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Primary outcome [3]
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Number of Safety Lead-In Participants With Adverse Events (AEs) Leading to Discontinuation
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Assessment method [3]
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The number of Safety Lead-In Participants who experienced an Adverse Event (AE) during the course of the study that lead to discontinuation of study therapy.
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Timepoint [3]
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From first dose to 30 days post-last dose (up to approximately 6 weeks)
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Primary outcome [4]
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Overall Survival (OS), Cohort 1 Only
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Assessment method [4]
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Overall survival (OS) is defined as the time between the date of diagnosis and the date of death in Cohort 1.
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Timepoint [4]
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up to approximately 42 months
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Primary outcome [5]
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Progression-Free Survival (PFS), Cohorts 2-4
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Assessment method [5]
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Progression-free survival (PFS) is defined as the time from first dose to the date of the first documented tumor progression or death due to any cause.
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Timepoint [5]
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up to approximately 42 months
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Primary outcome [6]
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Progression-Free Survival (PFS), Cohort 5 Only
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Assessment method [6]
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Progression-free survival (PFS) is defined as the time from first dose to the date of the first documented tumor progression or death due to any cause.
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Timepoint [6]
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up to approximately 42 months
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Secondary outcome [1]
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Progression-Free Survival (PFS), Cohort 1 Only
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Assessment method [1]
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Progression-free survival (PFS) is defined as the time from first dose to the date of the first documented tumor progression or death due to any cause.
Progression is defined as:
= 25% increase in sum of the products of perpendicular diameters of enhancing lesions compared with the smallest tumor measurement
Significant increase in T2 or fast fluid-attenuated inversion recovery (FLAIR) non-enhancing lesions on stable or increasing doses of corticosteroids
Any new lesion
Clear clinical deterioration not attributable to other causes apart from the tumor
Failure to return for evaluation as a result of death or deteriorating condition
Clear progression of non-measurable disease
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Timepoint [1]
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From first dose to the date of the first documented tumor progression or death due to any cause (up to approximately 55 months)
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Secondary outcome [2]
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Overall Survival at 12 Months (OS12), Cohorts 1-4
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Assessment method [2]
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Overall survival at 12 months (OS12) is defined as the percentage of participants who are alive at 12 months, measured as the survival rate at 12 months from Kaplan-Meier product limit cumulative probability.
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Timepoint [2]
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From first dose to up to 12 months after first dose
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Secondary outcome [3]
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Progression-Free Survival at 6 Months (PFS6), Cohorts 2-5
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Assessment method [3]
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Progression-free survival at 6 months (PFS6) is defined as the percentage of participants who are progression free and alive at 6 months following first dose date, measured as the survival rate at 6 months from Kaplan-Meier product limit cumulative probability of progression free.
Progression is defined as:
= 25% increase in sum of the products of perpendicular diameters of enhancing lesions compared with the smallest tumor measurement
Significant increase in T2 or fast fluid-attenuated inversion recovery (FLAIR) non-enhancing lesions on stable or increasing doses of corticosteroids
Any new lesion
Clear clinical deterioration not attributable to other causes apart from the tumor
Failure to return for evaluation as a result of death or deteriorating condition
Clear progression of non-measurable disease
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Timepoint [3]
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From first dose to up to 6 months after first dose
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Secondary outcome [4]
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Overall Survival (OS), Cohorts 2-5
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Assessment method [4]
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Overall survival (OS) is defined as the time between date of first dose and the date of death for Cohorts 2-5.
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Timepoint [4]
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From first dose to the date of death (up to approximately 55 months)
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Secondary outcome [5]
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Number of Treated Participants With Adverse Events (AEs)
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Assessment method [5]
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The number of treated participants who experienced an Adverse Event (AE) during the course of the study.
An AE is defined as any new untoward medical occurrence or worsening of a preexisting medical condition in a clinical investigation participant administered study drug and that does not necessarily have a causal relationship with this treatment. An AE can therefore be any unfavorable and unintended sign (such as an abnormal laboratory finding), symptom, or disease temporally associated with the use of study drug, whether or not considered related to the study drug.
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Timepoint [5]
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From first dose to 30 days post-last dose (up to approximately an average of 3 months and a maximum of 51 months)
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Secondary outcome [6]
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Number of Treated Participants With Serious Adverse Events (SAEs)
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Assessment method [6]
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The number of treated participants who experienced a Serious Adverse Event (SAE) during the course of the study.
SAE is defined as any untoward medical occurrence that, at any dose:
Results in death
Is life-threatening
Requires inpatient hospitalization or causes prolongation of existing hospitalization
Results in persistent or significant disability/incapacity
Is a congenital anomaly/birth defect
Is an important medical event
Note: The reporting timeframe of the SAEs for this Outcome Measure (first dose to 30 days post last dose) differs than that of the reporting timeframe of the SAEs reported under the AE section of the results form (first dose to 100 days post last dose) and thus, the data in each table of SAEs reflects the specific timeframe applied.
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Timepoint [6]
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From first dose to 30 days post-last dose (up to approximately an average of 3 months and a maximum of 51 months)
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Secondary outcome [7]
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Number of Treated Participants With Drug-Related Adverse Events
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Assessment method [7]
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The number of treated participants who experienced a Drug-Related Adverse Event during the course of the study.
An AE is defined as any new untoward medical occurrence or worsening of a preexisting medical condition in a clinical investigation participant administered study drug and that does not necessarily have a causal relationship with this treatment. An AE can therefore be any unfavorable and unintended sign (such as an abnormal laboratory finding), symptom, or disease temporally associated with the use of study drug, whether or not considered related to the study drug.
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Timepoint [7]
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From first dose to 30 days post-last dose (up to approximately an average of 3 months and a maximum of 51 months)
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Secondary outcome [8]
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Number of Treated Participants With Adverse Events Leading to Discontinuation
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Assessment method [8]
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The number of treated participants who experienced an Adverse Event leading to discontinuation during the course of the study.
An AE is defined as any new untoward medical occurrence or worsening of a preexisting medical condition in a clinical investigation participant administered study drug and that does not necessarily have a causal relationship with this treatment. An AE can therefore be any unfavorable and unintended sign (such as an abnormal laboratory finding), symptom, or disease temporally associated with the use of study drug, whether or not considered related to the study drug.
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Timepoint [8]
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From first dose to 30 days post-last dose (up to approximately an average of 3 months and a maximum of 51 months)
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Secondary outcome [9]
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Number of Treated Participant Deaths
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Assessment method [9]
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The number of treated participants who died during the course of the study.
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Timepoint [9]
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From first dose to the date of death (up to approximately 55 months)
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Secondary outcome [10]
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Number of Treated Participant With Laboratory Abnormalities - Liver
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Assessment method [10]
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The number of treated participants who experienced a laboratory abnormality of the liver during the course of the study.
Aspartate aminotransferase (AST) Alanine aminotransferase (ALT) Upper Limit of Normal (ULN) Units per Liter (U/L) Results reported in International System of Units (SI)
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Timepoint [10]
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From first dose to 30 days post-last dose (up to approximately an average of 3 months and a maximum of 51 months)
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Secondary outcome [11]
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Number of Treated Participant With Laboratory Abnormalities - Thyroid
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Assessment method [11]
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The number of treated participants who experienced a laboratory abnormality of the thyroid during the course of the study.
Free T3 (FT3) Free T4 (FT4) Thyroid stimulating hormone (TSH) Lower Limit of Normal (LLN) Upper limit of normal (ULN) Milliunits per Liter (mlU/L) Results reported in International System of Units (SI)
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Timepoint [11]
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From first dose to 30 days post-last dose (up to approximately an average of 3 months and a maximum of 51 months)
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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)
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Minimum age
6
Months
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Maximum age
21
Years
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Sex
Both males and females
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Can healthy volunteers participate?
No
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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
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Study design
Purpose of the study
Treatment
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Allocation to intervention
Non-randomised trial
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Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
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Methods used to generate the sequence in which subjects will be randomised (sequence generation)
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Masking / blinding
Open (masking not used)
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Who is / are masked / blinded?
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Intervention assignment
Parallel
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Other design features
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Phase
Phase 2
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Type of endpoint/s
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Statistical methods / analysis
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Recruitment
Recruitment status
Completed
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Data analysis
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Reason for early stopping/withdrawal
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Other reasons
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Date of first participant enrolment
Anticipated
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Actual
12/06/2017
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Date of last participant enrolment
Anticipated
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Actual
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Date of last data collection
Anticipated
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Actual
17/01/2022
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Sample size
Target
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Accrual to date
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Final
166
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Recruitment in Australia
Recruitment state(s)
NSW,QLD,VIC,WA
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Recruitment hospital [1]
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Local Institution - 0022 - Randwick
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Recruitment hospital [2]
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Local Institution - 0035 - Sth Brisbane
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Recruitment hospital [3]
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Local Institution - Clayton
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Recruitment hospital [4]
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Local Institution - 0034 - Parkville
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Recruitment hospital [5]
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Local Institution - 0033 - Nedlands
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Recruitment postcode(s) [1]
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2031 - Randwick
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Recruitment postcode(s) [2]
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4101 - Sth Brisbane
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Recruitment postcode(s) [3]
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3168 - Clayton
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Recruitment postcode(s) [4]
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3052 - Parkville
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Recruitment postcode(s) [5]
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6009 - Nedlands
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Recruitment outside Australia
Country [1]
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United States of America
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State/province [1]
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California
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Country [2]
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United States of America
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State/province [2]
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Colorado
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Country [3]
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United States of America
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State/province [3]
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Florida
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Country [4]
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United States of America
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State/province [4]
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Illinois
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Country [5]
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United States of America
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State/province [5]
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Maryland
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Country [6]
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United States of America
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State/province [6]
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Massachusetts
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Country [7]
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United States of America
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State/province [7]
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Missouri
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Country [8]
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United States of America
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State/province [8]
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New York
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Country [9]
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United States of America
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State/province [9]
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Ohio
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Country [10]
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United States of America
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State/province [10]
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Pennsylvania
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Country [11]
0
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United States of America
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State/province [11]
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South Carolina
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Country [12]
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United States of America
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State/province [12]
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Tennessee
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Country [13]
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United States of America
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State/province [13]
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Texas
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Country [14]
0
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Brazil
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State/province [14]
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RIO Grande DO SUL
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Country [15]
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Brazil
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State/province [15]
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Sao Paulo
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Country [16]
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Canada
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State/province [16]
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Ontario
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Country [17]
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Canada
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State/province [17]
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Quebec
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Country [18]
0
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France
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State/province [18]
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Angers
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Country [19]
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France
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State/province [19]
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Bordeaux Cedex
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Country [20]
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France
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State/province [20]
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Lille
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Country [21]
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France
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State/province [21]
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Lyon
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Country [22]
0
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France
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State/province [22]
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Marseille
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Country [23]
0
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France
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State/province [23]
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Paris
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Country [24]
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France
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State/province [24]
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Vandoeuvre les Nancy
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Country [25]
0
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France
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State/province [25]
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VIillejuif
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Country [26]
0
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Germany
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State/province [26]
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Essen
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Country [27]
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Germany
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State/province [27]
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Hamburg
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Country [28]
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Germany
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State/province [28]
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Heidelberg
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Country [29]
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Germany
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State/province [29]
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Wuerzburg
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Country [30]
0
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Hong Kong
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State/province [30]
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Hong Kong
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Country [31]
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Israel
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State/province [31]
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Haifa
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Country [32]
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Israel
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State/province [32]
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Ramat Gan
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Country [33]
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Netherlands
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State/province [33]
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Rotterdam
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Country [34]
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Netherlands
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State/province [34]
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Utrecht
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Country [35]
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Norway
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State/province [35]
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Oslo
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Country [36]
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Poland
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State/province [36]
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Warszawa
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Country [37]
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Russian Federation
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State/province [37]
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Moscow
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Country [38]
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Spain
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State/province [38]
0
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Esplugues de Llobregat
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Country [39]
0
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Spain
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State/province [39]
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Madrid
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Country [40]
0
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Spain
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State/province [40]
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Valencia
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Country [41]
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Sweden
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State/province [41]
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Solna
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Country [42]
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United Kingdom
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State/province [42]
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Greater London
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Country [43]
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United Kingdom
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State/province [43]
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Merseyside
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Country [44]
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United Kingdom
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State/province [44]
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Tyne And Wear
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Funding & Sponsors
Primary sponsor type
Commercial sector/Industry
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Name
Bristol-Myers Squibb
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Address
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Country
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Ethics approval
Ethics application status
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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.
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Trial website
https://clinicaltrials.gov/ct2/show/NCT03130959
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Trial related presentations / publications
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Public notes
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Contacts
Principal investigator
Name
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Bristol-Myers Squibb
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Address
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Bristol-Myers Squibb
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Country
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Phone
0
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Fax
0
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Email
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Contact person for public queries
Name
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Address
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Country
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Phone
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Fax
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Email
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Contact person for scientific queries
Summary Results
For IPD and results data, please see
https://clinicaltrials.gov/ct2/show/NCT03130959
Download to PDF