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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)

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. Read our disclaimer for details.
 
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

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

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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 7, 2017
Estimated Primary Completion Date : June 14, 2021
Estimated Study Completion Date : June 15, 2021

Resource links provided by the National Library of Medicine


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




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)).



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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


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


  Hide Study Locations
Locations
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United States, California
Children's Hospital Of Los Angeles
Los Angeles, California, United States, 90027
United States, Colorado
Children'S Hospital
Aurora, Colorado, United States, 80045
United States, Florida
Mcknight Brain Institute
Gainesville, Florida, United States, 32611
United States, Illinois
Children'S Memorial Hospital
Chicago, Illinois, United States, 60614
United States, Maryland
The Johns Hopkins Hospital
Baltimore, Maryland, United States, 21287
United States, Massachusetts
Dana-Farber Cancer Inst
Boston, Massachusetts, United States, 02215
United States, Missouri
Washington University
Saint Louis, Missouri, United States, 63110
United States, New York
The Herbert Irving Pavilion
New York, New York, United States, 10032
Memorial Sloan Kettering Cancer Center
New York, New York, United States, 10065
United States, Ohio
Cincinnati Childrens Hospital Medical Center
Cincinnati, Ohio, United States, 45229
United States, Pennsylvania
Children'S Hospital Of Philadelphia
Philadelphia, Pennsylvania, United States, 19104
United States, South Carolina
Medical University Of South Carolina
Charleston, South Carolina, United States, 29425
United States, Tennessee
St Jude Children'S Research Hospital
Memphis, Tennessee, United States, 38105
United States, Texas
Baylor College Of Medicine
Houston, Texas, United States, 77030
Australia, New South Wales
Local Institution
Randwick, New South Wales, Australia, 2031
Australia, Queensland
Local Institution
Sth Brisbane, Queensland, Australia, 4101
Australia, Victoria
Local Institution
Clayton, Victoria, Australia, 3168
Australia, Western Australia
Local Institution
Nedlands, Western Australia, Australia, 6009
Australia
Local Institution
Parkville, Australia, 3052
Brazil
Local Institution
Curitiba, Parana, Brazil, 80250-060
Local Institution
Porto Alegre, RIO Grande DO SUL, Brazil, 90035-074
Local Institution
Barretos, SAO Paulo, Brazil, 14784-400
Local Institution
Ribeirao Preto, SAO Paulo, Brazil, 14048-900
Local Institution
Sao Paulo, Brazil, 04023-062
Local Institution
Sao Paulo, Brazil, 08270-070
Canada, Ontario
Local Institution
Toronto, Ontario, Canada, M5G 1X8
Canada, Quebec
The Montreal Children's Hospital of the MUHC
Montreal, Quebec, Canada, H4A 3J1
Canada
CHU de Quebec
Quebec, Canada, G1V 4G2
France
Chu Angers
Angers, France, 49100
Hopital Pellegrin
Bordeaux Cedex, France, 33076
Local Institution
Lille, France, 59000
Local Institution
Lyon, France, 69008
Local Institution
Marseille, France, 13385 cedex 05
Institut Curie
Paris, France, 75231 cedex 5
Local Institution
Vandoeuvre les Nancy, France, 54500
Local Institution
VIillejuif, France, 94805 CEDEX
Germany
Universitaetsklinik Essen
Essen, Germany, 45147
Universitaetsklinikum Hamburg
Hamburg, Germany, 20246
Hopp Children's Cancer Center at NCT Heidelberg
Heidelberg, Germany, 69120
Univ. Klinikum Wuerzburg
Wuerzburg, Germany, 97080
Hong Kong
Local Institution
Hong Kong, Hong Kong
Israel
Local Institution
Haifa, Israel, 3109601
Local Institution
Ramat Gan, Israel, 5266202
Netherlands
Erasmus Mc , Locatie Sophia
Rotterdam, Netherlands, 3015 GJ
Prinses Maxima Centrum voor Kinderoncologie
Utrecht, Netherlands, 3584 CS
Norway
Local Institution
Oslo, Norway, 0027
Poland
Klinika Onkologii Centrum Zdrowia Dziecka
Warszawa, Poland, 04-730
Russian Federation
Local Institution
Moscow, Russian Federation, 117997
Local Institution
St. Petersburg, Russian Federation, 197089
Spain
Local Institution
Esplugues de Llobregat, Spain, 08950
Local Institution
Madrid, Spain, 28009
Local Institution
Valencia, Spain, 46026
Sweden
Local Institution
Solna, Sweden, 171 76
United Kingdom
Great Ormond Street Hospital For Children
London, Greater London, United Kingdom, WC1N 3JH
Alder Hey Children'S Hospital
Liverpool, Merseyside, United Kingdom, L12 2AP
Royal Victoria Infirmary
Newcastle Upon Tyne, Tyne and Wear, United Kingdom, NEI 4LP
Sponsors and Collaborators
Bristol-Myers Squibb
Investigators
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Study Director: Bristol-Myers Squibb Bristol-Myers Squibb

Additional Information:
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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: September 10, 2019
Last Verified: September 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Neoplasms
Nivolumab
Ipilimumab
Antineoplastic Agents, Immunological
Antineoplastic Agents