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 (CheckMate 908)

Bristol-Myers Squibb (BMS)

Status and phase: Completed; Phase 2

Conditions: Various Advanced Cancer

Treatments: Biological: Nivolumab; Biological: Ipilimumab

Study type: Interventional

Funder types: Industry

Identifiers

NCT03130959

CA209-908

2016-004441-82 (EudraCT Number)

Details and patient eligibility

About

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.

Enrollment: 166 patients

Sex: All

Ages: 6 months to 21 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• 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)

Exclusion criteria

• 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

Trial design

Primary purpose: Treatment

Allocation: Non-Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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166 participants in 2 patient groups

Module A

Experimental group

Treatment:

Biological: Nivolumab

Module B

Experimental group

Treatment:

Biological: Ipilimumab

Biological: Nivolumab