Phase III Trial of Radiotherapy Followed by Adjuvant Temozolomide in Combination with the IDH Inhibitor Vorasidenib vs Placebo in IDH-Mutated Newly-Diagnosed Grade 3 Astrocytomas

Sponsor:

Alliance for Clinical Trials in Oncology

Sponsor Study ID:

A072301

CTO #:

104365

NCT Number:

NCT07215910

Phase:

III

Protocol Type:

Treatment

Age Group:

Both

Disease Sites:

Brain and Nervous System

Study Objectives:

I. To determine if vorasidenib citrate (vorasidenib) and adjuvant temozolomide following radiation therapy improves progression-free survival (PFS) per blinded independent review in patients with newly-diagnosed IDH-mutant astrocytoma (World Health Organization [WHO] grade 3) compared to placebo given with adjuvant temozolomide following radiation therapy.

eConsent:

Not available

Study Documents:

Open Study Documents
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