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

Part of paid clinical trials in Pittsburgh, Pennsylvania.

Sponsor
Jason J. Luke, MD
Study ID
NCT04056910
Phase
PHASE2
Status
Completed

Conditions

  • Advanced Solid Tumor
  • Glioma
  • IDH1 Mutation

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • ivosidenib and nivolumab — DRUG
    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.

Study Details

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.

Key Dates

Start date
Sep 20, 2021
Status verified
Feb 2025
Primary completion
Nov 13, 2023
Completion
Nov 13, 2023

Study Design

Enrollment
15 participants (actual)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

Arms

  • Experimental: Concurrent dosing of ivosidenib and nivolumab
    Ivosidenib will be administered concurrently with nivolumab on a Q28 day schedule.

Primary Outcome Measure

Best Overall Response [ Time Frame: At 8 weeks after first treatment; up to 14 months for cohort ]

Locations (1)

FacilityCityStateZIPSite coordinators
UPMC Hillman Cancer CenterPittsburghPennsylvania15232-

Related coverage on Hipa.ai

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UPMC Hillman Cancer Center· Pittsburgh, PA

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