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Ivosidenib (AG-120) With Nivolumab in IDH1 Mutant Tumors

NCT04056910 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 15

Last updated 2025-02-27

Study results available
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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.

Conditions

  • Advanced Solid Tumor
  • IDH1 Mutation
  • Glioma

Interventions

DRUG

ivosidenib and nivolumab

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.

Sponsors & Collaborators

  • Agios Pharmaceuticals, Inc.

    collaborator INDUSTRY

  • Bristol-Myers Squibb

    collaborator INDUSTRY

  • Jason J. Luke, MD

    lead OTHER

Principal Investigators

  • Jason J Luke, MD, PhD · UPMC Hillman Cancer Center

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2021-09-20
Primary Completion
2023-11-13
Completion
2023-11-13
FDA Drug
Yes

Countries

  • United States

Study Locations

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Entities

Diseases
Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04056910 on ClinicalTrials.gov