A Study to Evaluate the Safety and Efficacy of Nivolumab Monotherapy and Nivolumab in Combination… (NCT03130959) | Clinical Trial Compass
CompletedPhase 2
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
United States, Australia, Brazil166 participantsStarted 2017-06-12
Plain-language 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.
Who can participate
Age range
6 Months – 21 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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 syndro…
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Number of Safety Lead-In Participants With Dose Limiting Toxicities (DLTs)
Timeframe: up to 6 weeks post-dosing
2
Number of Safety Lead-In Participants With Serious Adverse Events (SAEs)
Timeframe: up to 6 weeks post-dosing
3
Number of Safety Lead-In Participants With Adverse Events (AEs) Leading to Discontinuation
Timeframe: From first dose to 30 days post-last dose (up to approximately 6 weeks)