CI

At a glance

ClinicalIndex Comparison Record
Phase 2Completed· 15 enrolled
Drug / intervention
ivosidenib and nivolumabdrug
Likely dose
ivosidenib and nivolumab 500 mgfrom record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT04056910
NCT04056910Phase 2Completed
CompareCT.gov

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

Jason J. Luke, MD·interventional·Posted Aug 14, 2019·Updated Feb 27, 2025

In Brief

A Phase 2 clinical trial evaluating ivosidenib and nivolumab for Advanced Solid Tumor and 2 related conditions. Completed, enrolled 15 participants across 1 site.

Detailed 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.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsAdvanced Solid Tumor, IDH1 Mutation, Glioma
CountriesUnited States
CollaboratorsAgios Pharmaceuticals, Inc., Bristol-Myers Squibb

Timeline

Phase 2CompletedFinished
2020202120222023202420252026
First PostedAug 14, 2019
Enrollment StartSep 20, 2021
Primary CompletionNov 13, 2023
TodayJul 2, 2026
Enrollment to primary: 2.1 yearsPosted 6.9 years ago

Interventions

ivosidenib and nivolumabdrug

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.