Nivolumab for Recurrent or Progressive IDH Mutant Gliomas (NCT03557359) | Clinical Trial Compass
CompletedPhase 2
Nivolumab for Recurrent or Progressive IDH Mutant Gliomas
United States35 participantsStarted 2018-06-12
Plain-language summary
The objective of this study is to determine response rates (partial and complete responses) to nivolumab of recurrent or progressive IDH mutant (grades 2, 3 or 4) gliomas with prior exposure to alkylating agents.
Who can participate
Age range
18 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
. Female CrCl = (140 - age in years) x weight in kg x 0.85 72 x serum creatinine in mg/dL
. Male CrCl = (140 - age in years) x weight in kg x 1.00 72 x serum creatinine in mg/dL vi) Aspartate aminotransferase (AST) and alanine aminotransferase (ALT) ≤ 3.0 x ULN vii) Total bilirubin (TBILI) ≤ 1.5 x ULN (except participants with Gilbert Syndrome who must have a total bilirubin level of \< 3.0xULN)
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.
1This trial used nivolumab, a checkpoint inhibitor, for IDH-mutant gliomas specifically — does my tumor have an IDH mutation, and does that affect whether nivolumab might be relevant to my situation?
2Since this was a Phase 2 trial measuring overall response rate, what did the results actually show, and how does that compare to standard treatment options available to me right now?
3The trial is now completed — does that mean the findings have been published, and if so, what do those results suggest about the safety profile of nivolumab in people with recurrent or progressive gliomas like mine?
4Because this trial focused on recurrent or progressive gliomas, at what point in my treatment journey would it even make sense to consider an immunotherapy approach like this, and should I pursue standard therapies first?
5Are there any currently open trials building on what this nivolumab study found, that might be worth considering if my glioma recurs or stops responding to current treatment?
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
Overall Response Rate
Timeframe: Throughout treatment duration or until progressive disease, unacceptable toxicity, or withdrawal of consent, up to 2 years