Ivosidenib (AG-120) With Nivolumab in IDH1 Mutant Tumors (NCT04056910) | Clinical Trial Compass
CompletedPhase 2
Ivosidenib (AG-120) With Nivolumab in IDH1 Mutant Tumors
United States15 participantsStarted 2021-09-20
Plain-language summary
In this study, response to treatment and (progression free and overall) survival will be described and safety events of ivosidenib in combination with nivolumab will be summarized in patients with advanced solid tumors (nonresectable or metastatic) or enhancing gliomas.
Who can participate
Age range18 Years
SexALL
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Inclusion Criteria:
* Be ≥18 years of age.
* Have a histopathological diagnosis (fresh or banked tumor biopsy sample, preferably collected within the last 3 years) of an advanced solid tumor for which curative treatment is not available and have undergone appropriate standard of care treatment options (in the opinion of the treating investigator).
* Have a documented IDH1 gene-mutated disease (from a fresh tumor biopsy or the most recent banked tumor tissue available) based on CLIA certified sequencing (R132C/L/G/H/S mutation variants tested).
* For glioma, must have both 1) contrast enhancing disease and 2) WHO 2016 grade II
* Have an ECOG PS score of 0 or 1 (Appendix 11.1)
* Have at least one evaluable and measurable lesion as defined by RECIST v1.1 (solid tumors) or Response Assessment in Neuro-Oncology (RANO) Criteria (glioma).
* Have recovered from toxicities associated with prior anticancer therapy to baseline or ≤ grade 1 unless stabilized under medical management per investigator.
* Have adequate bone marrow function as evidenced by:
* Absolute neutrophil count ≥ 1,500/mm3 or 1.5 × 109/L
* Hemoglobin ≥ 8 g/dL
* Platelets ≥ 100,000/mm3 or 100 × 109/L
* Have adequate hepatic function as evidenced by:
* Serum total bilirubin ≤ 2 × upper limit of normal (ULN), unless considered due to Gilbert's disease
* Aspartate aminotransferase (AST) and alanine aminotransferase (ALT) ≤ 5 × ULN in the presence of liver metastases (or primary hepatic tumor) OR ≤ 2× ULN w…
What they're measuring
1
Best Overall Response
Timeframe: At 8 weeks after first treatment; up to 14 months for cohort