Surgical Nivolumab And Ipilimumab For Recurrent GBM (NCT04606316) | Clinical Trial Compass
Active — Not RecruitingPhase 1
Surgical Nivolumab And Ipilimumab For Recurrent GBM
United States63 participantsStarted 2021-02-01
Plain-language summary
This research trial is studying the safety and effectiveness of nivolumab in combination with ipilimumab and surgery when used in the treatment of recurrent glioblastoma.
The names of the study drugs involved in this study are:
* Nivolumab
* Ipilimumab
* Placebo (IV solution with no medicine)
* Zr-89 Crefmirlimab berdoxam (optional sub-study)
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:
* Have histologically confirmed World Health Organization Grade IV IDH wildtype glioblastoma or variants including gliosarcoma or IDH wildtype glioma with molecularly features of glioblastoma.
* Previous first line therapy with at least radiotherapy.
* Patients must be undergoing surgery that is clinically indicated as determined by their care providers.
* Be at first or second relapse. Note: Relapse is defined as progression following initial therapy (i.e., radiation ± chemotherapy).
* Participants must have shown unequivocal evidence for tumor progression by MRI per RANO criteria.
* Participants must have confirmation of availability of sufficient tissue from prior surgery revealing glioblastoma or variants for submission following registration. The following amount of tissue is required:
* 1 formalin-fixed paraffin-embedded (FFPE) tumor tissue block (preferred) OR
* 10 FFPE unstained slides (5 μm thick)
* An interval of at least 12 weeks from the completion of radiation therapy to registration unless there is unequivocal histologic confirmation of tumor progression.
* Participants must have recovered to grade 0 or 1 or pre-treatment baseline from clinically significant toxic effects of prior therapy (including but not limited to exceptions of alopecia, laboratory values listed per inclusion criteria, and lymphopenia (which is common after therapy with temozolomide).
* An interval of at least 4 weeks (to registration) between prior surgical resecti…
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.