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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 : Recruiting
First Posted : April 27, 2017
Last Update Posted : December 6, 2017
Sponsor:
Information provided by (Responsible Party):

Study Description
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

Condition or disease Intervention/treatment Phase
Various Advanced Cancer Biological: Nivolumab Biological: Ipilimumab Phase 2

Study Design

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 170 participants
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Phase Ib /II Clinical Trial of Nivolumab Monotherapy and Nivolumab in Combination With Ipilimumab in Pediatric Subjects With High Grade Primary CNS Malignancies
Actual Study Start Date : June 6, 2017
Estimated Primary Completion Date : June 14, 2021
Estimated Study Completion Date : June 15, 2021

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Arms and Interventions

Arm Intervention/treatment
Experimental: Module A
nivolumab
Biological: Nivolumab
Specified dose on specified day
Other Name: Opdivo, BMS-936558
Experimental: Module B
nivolumab plus ipilimumab
Biological: Nivolumab
Specified dose on specified day
Other Name: Opdivo, BMS-936558
Biological: Ipilimumab
Specified dose on specified day
Other Name: Yervoy, BMS-734016


Outcome Measures

Primary Outcome Measures :
  1. Incidence of dose limiting toxicity (DLT) [ Time Frame: Approximately 6 weeks ]
    Safety and tolerability

  2. Incidence of serious adverse events (SAEs) [ Time Frame: Approximately 6 weeks ]
    Safety and tolerability

  3. Incidence of adverse events (AEs) [ Time Frame: Approximately 6 weeks ]
    Safety and tolerability

  4. Overall Survival (OS) [ Time Frame: Approximately 3 years ]
    Diffuse Intrinsic Pontine Glioma (DIPG).

  5. Progression Free Survival (PFS) [ Time Frame: Approximately 2 years ]
    All other tumor types.


Secondary Outcome Measures :
  1. Incidence of AEs [ Time Frame: Approximately 3 years ]
    Safety

  2. Incidence of SAEs [ Time Frame: Approximately 3 years ]
    Safety

  3. Incidence of laboratory abnormalities [ Time Frame: Approximately 3 years ]
    Safety

  4. Progression Free Survival (PFS) [ Time Frame: 18 months to 24 months ]
    Diffuse Intrinsic Pontine Glioma (DIPG)

  5. Overall Survival [ Time Frame: Approximately 12 months ]
    Diffuse Intrinsic Pontine Glioma (DIPG). Overall Survival at 12 month point (OS(12)).

  6. 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)).

  7. Overall Survival (OS) [ Time Frame: Approximately 3 years ]
    High Grade Glioma (HGG), Medulloblastoma, Ependymoma, and other high-grade CNS tumors.

  8. Overall Survival [ Time Frame: Approximately 12 months ]
    High Grade Glioma (HGG), Medulloblastoma, Ependymoma. At 12 month point (OS(12)).


Eligibility Criteria

Information from the National Library of Medicine

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Ages Eligible for Study:   6 Months to 21 Years   (Child, Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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

Contacts and Locations

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03130959


Contacts
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 #.

  Show 58 Study Locations
Sponsors and Collaborators
Bristol-Myers Squibb
Investigators
Study Director: Bristol-Myers Squibb Bristol-Myers Squibb
More Information

Additional Information:
Responsible Party: Bristol-Myers Squibb
ClinicalTrials.gov Identifier: NCT03130959     History of Changes
Other Study ID Numbers: CA209-908
2016-004441-82 ( EudraCT Number )
First Posted: April 27, 2017    Key Record Dates
Last Update Posted: December 6, 2017
Last Verified: November 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No

Additional relevant MeSH terms:
Nivolumab
Antibodies, Monoclonal
Antineoplastic Agents
Immunologic Factors
Physiological Effects of Drugs