Clinical trials: IDH1-mutant Glioma
Advanced Malignant Solid Neoplasm, Glioblastoma
Olaparib in Treating Patients With Advanced Glioma, Cholangiocarcinoma, or Solid Tumors With IDH1 or IDH2 Mutations
This phase II trial studies how well olaparib works in treating patients with glioma, cholangiocarcinoma, or solid tumors with IDH1 or IDH2 mutations that has spread from where it first started (primary site) to other places in…
- Conditions
- Advanced Malignant Solid Neoplasm, Glioblastoma, Recurrent Cholangiocarcinoma, Recurrent Glioma
- Trial name
- NCT03212274
- Testing
- Biopsy Procedure, Biospecimen Collection, Computed Tomography
- Where
- 51 sites in United States
- Volunteers
- 89 people
- Sponsor
- National Cancer Institute (NCI)
Glioma
Study of AG-120 and AG-881 in Subjects With Low Grade Glioma
Study to evaluate the suppression of 2-HG (2-hydroxyglutarate) in IDH-1 mutant gliomas in resected tumor tissue following pre-surgical treatment with AG-120 or AG-881.
- Trial name
- NCT03343197
- Testing
- AG-120, AG881
- Where
- 6 sites in United States
- Volunteers
- 49 people
- Sponsor
- Institut de Recherches Internationales Servier
IDH1-mutant Glioma, IDH2-mutant Glioma
Vorasidenib in Combination With Temozolomide (TMZ) in IDH-mutant Glioma
The objective of this study is to determine the safety and tolerability of vorasidenib in combination with temozolomide (TMZ) and to establish the recommended combination dose (RCD) of vorasidenib.
- Trial name
- NCT06478212
- Testing
- Vorasidenib, Temozolomide (TMZ)
- Where
- 28 sites in United States, Austria and 9 more
- Volunteers
- 51 people
- Sponsor
- Institut de Recherches Internationales Servier
Glioblastoma, IDH1 Gene Mutation
BGB-290 and Temozolomide in Treating Isocitrate Dehydrogenase (IDH)1/2-Mutant Grade I-IV Gliomas
This phase I trial studies the side effects and best dose of BGB-290 and temozolomide in treating adolescents and young adults with IDH1/2-mutant grade I-IV glioma that is newly diagnosed or has come back.
- Conditions
- Glioblastoma, IDH1 Gene Mutation, IDH2 Gene Mutation, Low Grade Glioma
- Trial name
- PNOC017 (NCT03749187)
- Testing
- PARP Inhibitor BGB-290, Temozolomide (TMZ)
- Where
- 11 sites in United States
- Volunteers
- 78 people
- Sponsor
- University of California, San Francisco
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
Gliomas Harboring IDH1 and/or IDH2 Mutations, Glioma Glioblastoma Multiforme
Multicenter Prospective Study on MRI AI Model for Midline Glioma Subtyping and Prognosis:
A vision-language model using preoperative MRI and clinical variables has been developed to simultaneously predict three key molecular markers in midline gliomas: H3K27M, IDH, and 1p/19q.
- Conditions
- Gliomas Harboring IDH1 and/or IDH2 Mutations, Glioma Glioblastoma Multiforme, Glioma of Brainstem, Glioma, Diffuse Midline, H3K27M-mutant
- Trial name
- NCT07608003
- Where
- China
- Volunteers
- 500 people
- Sponsor
- Xiangya Hospital of Central South University
Glioma
Trial of IDH305 in IDH1 Mutant Grade II or III Glioma
The purpose of this study is to found out if the drug IDH305 is safe and effective in subjects with IDH1 mutant grade II or III glioma that has progressed after observation or radiation therapy.
- Trial name
- NCT02977689
- Testing
- IDH305
- Where
- United States
- Sponsor
- NYU Langone Health
Recurrent Glioma, IDH-mutant Gliomas
VorAsidenib With Lomustine In Patients With rEcurrent IDH-mutaNT Glioma Harboring IDH1 and/or IDH2 Mutations
This phase I study will evaluate the safety and tolerability of vorasidenib in combination with lomustine and determine the recommended combination dose (RCD) of vorasidenib in adults with recurrent IDH1- or IDH2-mutant glioma.
- Trial name
- VALIENT (NCT07629089)
- Testing
- Vorasidenib, Lomustine
- Where
- United States
- Volunteers
- 36 people
- Sponsor
- Megan Mantica
Advanced Solid Tumor, IDH1 Mutation
Ivosidenib (AG-120) With Nivolumab in IDH1 Mutant Tumors
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…
- Conditions
- Advanced Solid Tumor, IDH1 Mutation, Glioma
- Trial name
- NCT04056910
- Testing
- ivosidenib and nivolumab
- Where
- United States
- Volunteers
- 15 people
- Sponsor
- Jason J. Luke, MD
WHO Grade II Glioma
A Study of DS-1001b in Patients With Chemotherapy- and Radiotherapy-Naive IDH1 Mutated WHO Grade II Glioma
This Phase 2 study is conducted to assess the efficacy and safety of DS-1001b in patients with chemotherapy- and radiotherapy-naive IDH1 mutated WHO grade II glioma.
- Trial name
- NCT04458272
- Testing
- DS-1001b
- Where
- 11 sites in Japan
- Volunteers
- 25 people
- Sponsor
- Daiichi Sankyo Co., Ltd.
Astrocytoma, Oligodendroglioma
Study of Vorasidenib and Pembrolizumab Combination in Recurrent or Progressive IDH-1 Mutant Glioma
Vorasidenib in combination with pembrolizumab in participants with recurrent or progressive isocitrate dehydrogenase-1 (IDH-1) mutant Glioma.
- Trial name
- NCT05484622
- Testing
- Vorasidenib, Pembrolizumab
- Where
- 17 sites in United States
- Volunteers
- 60 people
- Sponsor
- Institut de Recherches Internationales Servier
Low Grade Glioma of Brain
ViCToRy: Vorasidenib in Combination With Tumor Specific Peptide Vaccine for Recurrent IDH1 Mutant Lower Grade Gliomas
The purpose of this study is to determine the safety and efficacy of a PEPIDH1M vaccine in combination with vorasidenib, a dual inhibitor of mutant IDH1 and IDH2 enzymes, in adult patients diagnosed with recurrent IDH1 mutant…
- Trial name
- ViCToRy (NCT05609994)
- Testing
- PEPIDH1M vaccine + vorasidenib
- Where
- United States
- Volunteers
- 48 people
- Sponsor
- Katy Peters, MD, PhD
Glioblastoma, Glioblastoma Multiforme
Trial of Niraparib in Participants With Newly-diagnosed Glioblastoma and Recurrent Glioma
This is an open-label, multi-center Phase 0 study with an expansion phase that will enroll up to 24 participants with newly-diagnosed glioblastoma and up to 18 recurrent glioma participants with IDH mutation and ATRX loss.
- Conditions
- Glioblastoma, Glioblastoma Multiforme, Glioma, GBM
- Trial name
- NCT05076513
- Testing
- Niraparib, Radiation therapy
- Where
- United States
- Volunteers
- 42 people
- Sponsor
- Nader Sanai
Low Grade Glioma of Brain
Repeatability of Magnetic Resonance Imaging in Patients With IDH1 Mutant Glioma on Ivosidenib
The purpose of this study is to evaluate the repeatability of magnetic resonance imaging (MRI) in patients with isocitrate dehydrogenase 1 (IDH1) mutant (mIDH1) low-grade diffuse glioma [World Health Organization (WHO) grade 2]…
- Trial name
- NCT06648473
- Testing
- MRI Scan
- Where
- United States
- Sponsor
- Duke University
Glioma : Oligodendroglioma or Astrocytoma
Safusidenib for Patients With Newly Diagnosed IDH1-mutant CNS WHO Grade 3 Oligodendroglioma and Astrocytoma - a Single Arm Phase II Study
The precise positioning of the emerging group of pharmacological inhibitors of mutant IDH enzymes remains to be refined by further studies and defined in national and international guidelines.
- Trial name
- SAFU-G3 (NCT07832123)
- Testing
- Safusidenib
- Where
- Switzerland
- Volunteers
- 20 people
- Sponsor
- University of Zurich
Residual or Recurrent Grade 2 IDH Mutant Glioma
Phase 3 Study of Vorasidenib (S095032/AG-881) in Asian Participants With Residual or Recurrent Grade 2 Glioma With an IDH1 orIDH2 Mutation
The objective of this study is to determine the efficacy, safety, and pharmacokinetics of vorasidenib in Asian participants with residual or recurrent Grade 2 glioma with an IDH1 or IDH2 mutation.
- Trial name
- NCT06780930
- Testing
- Vorasidenib
- Where
- 8 sites in China, Taiwan
- Volunteers
- 57 people
- Sponsor
- Servier
Glioma
Residual IDH1-Mutant Tumor Cell Quantification Study
This is a single-site, single-arm, prospective, interventional cohort study using intraoperative ultra-rapid droplet digital polymerase chain reaction (UR- ddPCR) to assess residual IDH1-mutant tumor at the end of surgical…
- Trial name
- NCT07219199
- Testing
- UR-ddPCR
- Where
- United States
- Volunteers
- 105 people
- Sponsor
- NYU Langone Health
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
Epilepsy; Seizure
ES-481 for Uncontrolled Glioma-Associated Epilepsy and Assessment for Potential Anti-Tumorigenic Effect in Patients With Isocitrate Dehydrogenase 1 (IDH1) Mutant Tumors
Phase 2A single-arm exploratory clinical study in up to 12 adult subjects aged 18 and older with primary glioma, IDH1 mutation, and uncontrolled focal-onset seizure activity to determine the potential efficacy, safety and…
- Trial name
- NCT04737174
- Testing
- ES-481
- Sponsor
- ES Therapeutics Australia Pty Ltd
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.