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

Completed · Phase 2

Conditions studied: Various Advanced Cancer

In brief

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.

Key facts

Study ID: NCT03130959
Run by: Bristol-Myers Squibb
People needed: 166
Starts: 2017-06-12
Expected to finish: 2022-01-17
Last updated by the study team: 2022-08-09

Who can join

Age: 1 and older, up to 21. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

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)

You may not qualify if…

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

Where it is running

Local Institution - 0016 — Aurora, Colorado, United States
Local Institution - 0046 — Gainesville, Florida, United States
Local Institution - 0011 — Chicago, Illinois, United States
Local Institution - 0005 — Baltimore, Maryland, United States
Local Institution - 0043 — Boston, Massachusetts, United States
Local Institution - 0044 — St Louis, Missouri, United States
Local Institution - 0004 — New York, New York, United States
Local Institution - 0017 — New York, New York, United States
Cincinnati Children'S Hospital Medical Center — Cincinnati, Ohio, United States
Local Institution - 0066 — Philadelphia, Pennsylvania, United States
Local Institution — Charleston, South Carolina, United States
Local Institution - 0012 — Memphis, Tennessee, United States
Local Institution - 0042 — Houston, Texas, United States
Local Institution - 0022 — Randwick, New South Wales, Australia
Local Institution - 0035 — Sth Brisbane, Queensland, Australia
Local Institution — Clayton, Victoria, Australia
Local Institution - 0034 — Parkville, Victoria, Australia
Local Institution - 0033 — Nedlands, Western Australia, Australia
Local Institution - 0052 — Porto Alegre, Rio Grande do Sul, Brazil
Local Institution - 0051 — Barretos, São Paulo, Brazil
Local Institution - 0053 — Ribeirão Preto, São Paulo, Brazil
Local Institution - 0049 — São Paulo, Brazil
Local Institution - 0050 — São Paulo, Brazil
Local Institution - 0021 — Toronto, Ontario, Canada
Local Institution - 0057 — Los Angeles, California, United States

Full record on ClinicalTrials.gov

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