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Report for Clinical Trial NCT04056910

Developed by Shray Alag, 2020.
SNP Clinical Trial Gene

Phase II Study of IDH1 Inhibitor Ivosidenib and Nivolumab in IDH1 Mutant Gliomas and Advanced Solid Tumors

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.

NCT04056910 Advanced Solid Tumor IDH1 Mutation Glioma
MeSH:Glioma
HPO:Glioma

1 Interventions

Name: ivosidenib and nivolumab

Description: Ivosidenib will be administered orally at a dose of 500 mg (provided as 250 mg strength tablets) daily. The dose may be reduced to 250 mg for patients experiencing more than one event of Grade 2 nausea or vomiting (related or unrelated), or Grade 3 or Grade 4 adverse events. Nivolumab will be administered at 480 mg IV every 28 days.
Type: Drug
Group Labels: 1

Concurrent dosing of ivosidenib and nivolumab


Primary Outcomes

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 months

Description: 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 months

Description: 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 months

Secondary Outcomes

Description: 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 months

Description: 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 months

Description: 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 months

Purpose: Treatment

Allocation: N/A

Single Group Assignment


There is one SNP

SNPs


1 R132C

- 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 ---



HPO Nodes


HPO: