Clinical trials: Grade 2 IDH1-mutant Glioma, open to volunteers
Recurrent IDH1R132H-mutant Astrocytoma, Grade 2 - 4
A Multicenter Safety and Immunogenicity Window-of-opportunity Phase 1 Interventional Trial Assessing the Combination of IDH1 Vaccine (IDH1-vac) and Vorasidenib in Adult Patients With Recurrent IDH1R132H-mutant Astrocytoma, Grade 2 - 4 (iVOCAL)
The study aims to investigate the combination of the IDH1R132H peptide vaccine and the dual IDH1/2 inhibitor vorasidenib in patients with recurrent and/or progressive astrocytoma, WHO grade 2,3 and 4.
- Trial name
- iVOCAL (NCT07877415)
- Testing
- IDH1R132H-vac, Vorasidenib 40 mg Oral Tablet, Aldara - Imiquimod 5%
- Volunteers
- 45 people
- Sponsor
- Heidelberg University
Astrocytoma, IDH-Mutant, Grade 3, Astrocytoma, IDH-Mutant, Grade 4
IDH1-vac in Patients With Newly Diagnosed IDH1R132H-positive High-grade Astrocytomas
STAR-VACC is a randomized double-blind controlled Phase 2 study assessing clinical efficacy of IDH1-vac in patients with newly diagnosed IDH1-mutant high-grade astrocytomas.
- Trial name
- STAR-VACC (NCT07888647)
- Testing
- IDH1-vac, IS-vac, Temozolomide (TMZ)
- Where
- 13 sites in Germany
- Volunteers
- 216 people
- Sponsor
- German Cancer Research Center
Grade 2 IDH1-mutant Glioma, Grade 3 IDH1-mutant Glioma
Safety and Efficacy Study of Safusidenib in Participants With IDH1-Mutant Glioma Who Discontinued Vorasidenib Treatment Due to Progressive Disease
This study will include up to 40 participants with Grade 2 or Grade 3 IDH1-mutant glioma who have undergone surgery and received vorasidenib as their only treatment, experienced radiographic disease progression on vorasidenib…
- Conditions
- Grade 2 IDH1-mutant Glioma, Grade 3 IDH1-mutant Glioma, Glioma, IDH1-mutant Glioma
- Trial name
- NCT07703436
- Testing
- Safusidenib
- Where
- 12 sites in United States
- Volunteers
- 40 people
- Sponsor
- Nuvation Bio Inc.
Glioma, Astrocytoma, Grade IV
SIGMA (Safusidenib in IDH1 Mutant Glioma Maintenance)
This is a 3-part study. The purpose of Part 1 of the study is to evaluate the efficacy, safety, and pharmacokinetic (PK) characteristics of safusidenib in participants with recurrent/progressive IDH1-mutant World Health…
- Conditions
- Glioma, Astrocytoma, Grade IV, IDH1-mutant Glioma, Astrocytoma, IDH-Mutant, Grade 3
- Trial name
- SIGMA (NCT05303519)
- Testing
- safusidenib
- Where
- 61 sites in United States, Australia and 1 more
- Volunteers
- 365 people
- Sponsor
- Nuvation Bio Inc.
Grade 2 Glioma (Astrocytoma or Oligodendroglioma) With an IDH1 Mutation, Astrocytoma IDH Mutant Grade 2
Safety and Efficacy Study of Safusidenib in Participants With Grade 2 IDH1-Mutant Glioma
This is a Phase 3, randomized, double-blind, placebo-controlled, multicenter study comparing the efficacy and safety of safusidenib versus placebo in participants with residual or recurrent Grade 2 glioma (oligodendroglioma or…
- Conditions
- Grade 2 Glioma (Astrocytoma or Oligodendroglioma) With an IDH1 Mutation, Astrocytoma IDH Mutant Grade 2, Oligodendroglioma, Oligodendroglioma IDH-mutant and 1p/19q-codeleted
- Trial name
- NCT07712757
- Testing
- Safusidenib
- Volunteers
- 140 people
- Sponsor
- Nuvation Bio Inc.
High Grade Glioma, Astrocytoma
Study of Olutasidenib and Temozolomide in HGG
The goal of this study is to determine the efficacy of the study drug olutasidenib to treat newly diagnosed pediatric and young adult patients with a high-grade glioma (HGG) harboring an IDH1 mutation.
- Conditions
- High Grade Glioma, Astrocytoma, Astrocytoma, Grade III, Astrocytoma, Grade IV
- Trial name
- NCT06161974
- Testing
- Olutasidenib + TMZ
- Where
- 20 sites in United States, Australia and 5 more
- Volunteers
- 60 people
- Sponsor
- Rigel Pharmaceuticals