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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)

This study is currently recruiting participants.
Verified November 2017 by Bristol-Myers Squibb
Sponsor:
ClinicalTrials.gov Identifier:
NCT03130959
First Posted: April 27, 2017
Last Update Posted: December 6, 2017
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 evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
Information provided by (Responsible Party):
Bristol-Myers Squibb
April 5, 2017
April 27, 2017
December 6, 2017
June 6, 2017
June 14, 2021   (Final data collection date for primary outcome measure)
  • 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.
Same as current
Complete list of historical versions of study NCT03130959 on ClinicalTrials.gov Archive Site
  • 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)).
Same as current
Not Provided
Not Provided
 
An Investigational Immuno-therapy Study of Nivolumab Monotherapy and Nivolumab in Combination With Ipilimumab in Pediatric Patients With High Grade Primary CNS Malignancies
Phase Ib /II Clinical Trial of Nivolumab Monotherapy and Nivolumab in Combination With Ipilimumab in Pediatric Subjects With High Grade Primary CNS Malignancies
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
Not Provided
Interventional
Phase 2
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Various Advanced Cancer
  • Biological: Nivolumab
    Specified dose on specified day
    Other Name: Opdivo, BMS-936558
  • Biological: Ipilimumab
    Specified dose on specified day
    Other Name: Yervoy, BMS-734016
  • Experimental: Module A
    nivolumab
    Intervention: Biological: Nivolumab
  • Experimental: Module B
    nivolumab plus ipilimumab
    Interventions:
    • Biological: Nivolumab
    • Biological: Ipilimumab
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
170
June 15, 2021
June 14, 2021   (Final data collection date for primary outcome measure)

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

Sexes Eligible for Study: All
6 Months to 21 Years   (Child, Adult)
No
Contact: Recruiting sites have contact information. Please contact the sites directly. If there is no contact information, please email: Clinical.Trials@bms.com
Contact: First line of the email MUST contain NCT # and Site #.
Australia,   Brazil,   Canada,   France,   Germany,   Hong Kong,   Israel,   Netherlands,   Poland,   Russian Federation,   Spain,   United Kingdom,   United States
 
 
NCT03130959
CA209-908
2016-004441-82 ( EudraCT Number )
Yes
Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Plan to Share IPD: No
Bristol-Myers Squibb
Bristol-Myers Squibb
Not Provided
Study Director: Bristol-Myers Squibb Bristol-Myers Squibb
Bristol-Myers Squibb
November 2017

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