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An Investigational Immuno-therapy Study of Nivolumab Monotherapy and Nivolumab in Combination With Ipilimumab in Pediatric Patients With High Grade Primary CNS Malignancies (CheckMate 908)

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ClinicalTrials.gov Identifier: NCT03130959
Recruitment Status : Active, not recruiting
First Posted : April 27, 2017
Last Update Posted : September 10, 2019
Sponsor:
Information provided by (Responsible Party):
Bristol-Myers Squibb

Tracking Information
First Submitted Date  ICMJE April 5, 2017
First Posted Date  ICMJE April 27, 2017
Last Update Posted Date September 10, 2019
Actual Study Start Date  ICMJE June 7, 2017
Estimated Primary Completion Date June 14, 2021   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: April 24, 2017)
  • Incidence of dose limiting toxicity (DLT) [ Time Frame: Approximately 6 weeks ]
    Safety and tolerability
  • Incidence of serious adverse events (SAEs) [ Time Frame: Approximately 6 weeks ]
    Safety and tolerability
  • Incidence of adverse events (AEs) [ Time Frame: Approximately 6 weeks ]
    Safety and tolerability
  • Overall Survival (OS) [ Time Frame: Approximately 3 years ]
    Diffuse Intrinsic Pontine Glioma (DIPG).
  • Progression Free Survival (PFS) [ Time Frame: Approximately 2 years ]
    All other tumor types.
Original Primary Outcome Measures  ICMJE Same as current
Change History Complete list of historical versions of study NCT03130959 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: April 24, 2017)
  • Incidence of AEs [ Time Frame: Approximately 3 years ]
    Safety
  • Incidence of SAEs [ Time Frame: Approximately 3 years ]
    Safety
  • Incidence of laboratory abnormalities [ Time Frame: Approximately 3 years ]
    Safety
  • Progression Free Survival (PFS) [ Time Frame: 18 months to 24 months ]
    Diffuse Intrinsic Pontine Glioma (DIPG)
  • Overall Survival [ Time Frame: Approximately 12 months ]
    Diffuse Intrinsic Pontine Glioma (DIPG). Overall Survival at 12 month point (OS(12)).
  • Progression Free Survival [ Time Frame: Approximately 6 months ]
    High Grade Glioma (HGG), Medulloblastoma, Ependymoma, and other high-grade CNS tumors. At 6 months (PFS(6)).
  • Overall Survival (OS) [ Time Frame: Approximately 3 years ]
    High Grade Glioma (HGG), Medulloblastoma, Ependymoma, and other high-grade CNS tumors.
  • Overall Survival [ Time Frame: Approximately 12 months ]
    High Grade Glioma (HGG), Medulloblastoma, Ependymoma. At 12 month point (OS(12)).
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE An Investigational Immuno-therapy Study of Nivolumab Monotherapy and Nivolumab in Combination With Ipilimumab in Pediatric Patients With High Grade Primary CNS Malignancies
Official Title  ICMJE Phase Ib /II Clinical Trial of Nivolumab Monotherapy and Nivolumab in Combination With Ipilimumab in Pediatric Subjects With High Grade Primary CNS Malignancies
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
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 2
Study Design  ICMJE Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE Various Advanced Cancer
Intervention  ICMJE
  • Biological: Nivolumab
    Specified dose on specified day
    Other Name: Opdivo, BMS-936558
  • Biological: Ipilimumab
    Specified dose on specified day
    Other Name: Yervoy, BMS-734016
Study Arms  ICMJE
  • Experimental: Module A
    nivolumab
    Intervention: Biological: Nivolumab
  • Experimental: Module B
    nivolumab plus ipilimumab
    Interventions:
    • Biological: Nivolumab
    • Biological: Ipilimumab
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Active, not recruiting
Estimated Enrollment  ICMJE
 (submitted: April 24, 2017)
170
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE June 15, 2021
Estimated Primary Completion Date June 14, 2021   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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]

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

Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 6 Months to 21 Years   (Child, Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Australia,   Brazil,   Canada,   France,   Germany,   Hong Kong,   Israel,   Netherlands,   Norway,   Poland,   Russian Federation,   Spain,   Sweden,   United Kingdom,   United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT03130959
Other Study ID Numbers  ICMJE CA209-908
2016-004441-82 ( EudraCT Number )
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE
Plan to Share IPD: No
Responsible Party Bristol-Myers Squibb
Study Sponsor  ICMJE Bristol-Myers Squibb
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Director: Bristol-Myers Squibb Bristol-Myers Squibb
PRS Account Bristol-Myers Squibb
Verification Date September 2019

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP