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 range18 Years
SexALL
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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 ÎĽm 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…