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.
Name: ivosidenib and nivolumab
Description: The occurrence (number) of dose limiting toxicity (DLT) in patients receiving ivosidenib plus nivolumab. DLT describes side effects of the treatment that are serious enough to prevent an increase in dose or level of that treatment.
Measure: Occurrence of dose limiting toxicity (DLT) Time: Up to 24 monthsDescription: RECIST v1.1 Criteria:Complete Response (CR): Disappearance of all target lesions. Any pathological lymph nodes (target or non-target) with reduction in short axis to <10 mm. Partial Response (PR): ≥30% decrease in the sum of diameters of target lesions, taking as reference the baseline sum diameters. Stable Disease (SD): Neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for PD, taking as reference the smallest sum diameters while on study. RANO Criteria:Complete Response (CR):Observed in consecutive assessments ≥4 weeks apart per RANO. Partial Response (PR): Observed in consecutive assessments ≥4 weeks apart per RANO.
Measure: Best Overall Response Time: Up to 24 monthsDescription: The time from first dose of either drug until disease progression or death from any cause, whichever occurs first. RECIST v1.1 Criteria: Progressive Disease (PD):≥20% increase in the sum of diameters of target lesions, taking as reference the smallest sum on study (this includes the baseline sum if that is the smallest on study). The sum must also demonstrate an absolute increase of ≥5 mm. The appearance ≥1 new lesion(s) is considered progression. RANO Criteria: Progressive Disease: No CR, PR, SD prior to PD.RANO Criteria: Progressive Disease: No CR, PR, SD prior to PD. Progression: 25% or more increase in enhancing lesions despite stable or increasing steroid dose, increase (significant) in non-enhancing FLAIR/T2W lesions, not attributable to other non-tumor causes, any new lesions; clinical deterioration (not attributable to other non-tumor causes and not due to steroid decrease)
Measure: Progression Free Survival (PFS) Time: Up to 36 monthsDescription: Adverse events per NCI Common Terminology Criteria for Adverse Events (CTCAE v5.0), experienced by patients related to their receiving the treatment combination of ivosidenib and nivolumab.
Measure: Adverse Events Related to Treatment Time: Up to 24 monthsDescription: The length of time from the start of treatment that patients diagnosed with the disease are still alive.
Measure: Overall Survival (OS) Time: Up to 36 monthsDescription: Solid Tumor-Progression per RECIST v1.1 Criteria:Progressive Disease (PD):≥20% increase in the sum of diameters of target lesions, taking as reference the smallest sum on study (this includes the baseline sum if that is the smallest on study). The sum must also demonstrate an absolute increase of ≥5 mm. The appearance ≥1 new lesion(s) is considered progression. Glioma-Tumor progression per RANO Criteria: Progressive Disease: No CR, PR, SD prior to PD. Progression: 25% or more increase in enhancing lesions despite stable or increasing steroid dose, increase (significant) in non-enhancing FLAIR/T2W lesions, not attributable to other non-tumor causes, any new lesions; clinical deterioration (not attributable to other non-tumor causes and not due to steroid decrease)
Measure: Objective Tumor Progression Time: Up to 24 monthsAllocation: N/A
Single Group Assignment
There is one SNP
- 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). --- R132C ---