Clinical trials: IDH-mutant Gliomas
Recurrent CNS Tumors, Brain Cancer
Observational Study of Responses to Treatments in Advanced Central Nervous System (CNS) Tumors
Background: Primary central nervous system (CNS) tumors grow in the brain and spinal cord. These tumors are rare, but they are difficult to treat and often fatal.
- Conditions
- Recurrent CNS Tumors, Brain Cancer, Gliomas, IDH-wildtype Gliomas
- Trial name
- NCT07374692
- Testing
- SmartMatch testing
- Where
- United States
- Volunteers
- 4 people
- Sponsor
- National Cancer Institute (NCI)
Astrocytoma, Grade IV
ALBATROSS Study: International Multicenter Study for Prospective Validation of Imaging Biomarkers Calculated at Vascular Habitats of High-grade Gliomas
This Clinical study is framed in the ALBATROSS Project: Clinically validated decision support system based on pixel level Artificial Intelligent models for deciding treatment in glioblastoma.
- Trial name
- ALBATROSS (NCT05229198)
- Where
- Spain
- Volunteers
- 300 people
- Sponsor
- Juan M Garcia-Gomez
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
Oligodendroglioma, Oligodendroglioma, Anaplastic
PRO-GLIO: PROton Versus Photon Therapy in IDH-mutated Diffuse Grade II and III GLIOmas
Proton therapy is a powerful tool enabling oncologists to spare normal tissue around the target for irradiation much better than what can be achieved with photon irradiation.
- Conditions
- Oligodendroglioma, Oligodendroglioma, Anaplastic, Diffuse Astrocytoma, IDH-Mutant
- Trial name
- PRO-GLIO (NCT05190172)
- Testing
- Radiation therapy
- Where
- Norway
- Volunteers
- 225 people
- Sponsor
- Oslo University Hospital
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
Glioblastoma, Astrocytoma, IDH-Mutant, Grade 4
Extensive Resection of Malignant Brain Tumors Using Advanced Imaging Techniques
Rationale: Patients with IDH-wildtype glioblastoma or grade IV IDH-mutant astrocytoma have a very poor prognosis despite standard treatment consisting of surgery, radiotherapy, and chemotherapy.
- Trial name
- NEXTFRONTIER (NCT06623565)
- Testing
- Multimodal image-guided resection
- Where
- Netherlands
- Volunteers
- 30 people
- Sponsor
- Amsterdam UMC, location VUmc
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
Pediatric Tumor of CNS, Pediatric Tumor of Brain
A Study of the Safety, Dosing, and Delivery of NEO100 in Patients With Pediatric Brain Tumors
This is an open label, Phase 1b safety, dose-finding, brain tumor delivery, and pharmacokinetics study of intranasal NEO100 in patients with pediatric-type diffuse high grade gliomas.
- Conditions
- Pediatric Tumor of CNS, Pediatric Tumor of Brain, Diffuse Midline Glioma, H3 K27M-Mutant, Pediatric Tumor of Brain Stem
- Trial name
- NCT06357377
- Testing
- NEO100
- Where
- United States
- Volunteers
- 12 people
- Sponsor
- Neonc Technologies, Inc.
Recurrent IDH, Mutant High Grade Glioma
Olaparib in Recurrent IDH-mutant Glioma
Recent data demonstrate that in IDH-mutant gliomas, 2 hydroxy-glutarate production induces a homologous recombination defect that renders tumor cells exquisitely sensitive to poly(adenosine 5'-diphosphate-ribose) polymerase…
- Trial name
- OLAGLI (NCT03561870)
- Testing
- Olaparib 150 MG
- Where
- France
- Volunteers
- 35 people
- Sponsor
- Hospices Civils de Lyon
Glioma, Diffuse Glioma
Vorasidenib Guided by AGX PET in Recurrent/Low-grade Glioma
The goal of this prospective, single-arm, open-label clinical trial is to evaluate whether 18F-AGX PET imaging can be used to assess early treatment response and metabolic changes in adult patients with recurrent or residual WHO…
- Conditions
- Glioma, Diffuse Glioma, Recurrent Gliomas
- Trial name
- VANGUARD (NCT07469735)
- Testing
- Oral Vorasidenib administered once daily for up to 12 treatment cycles (28 days per cycle) as IDH-targeted therapy in participants with recurrent or residual IDH-mutant diffuse glioma.
- Where
- China
- Volunteers
- 10 people
- Sponsor
- Huashan Hospital
Astrocytoma, IDH-Mutant, Grade 4, Diffuse Glioma
A Study Testing the Effect of Immunotherapy (Ipilimumab and Nivolumab) in Patients With Recurrent Glioma With Elevated Mutational Burden
This phase II trial studies the effect of immunotherapy drugs (ipilimumab and nivolumab) in treating patients with glioma that has come back (recurrent) and carries a high number of mutations (mutational burden).
- Conditions
- Astrocytoma, IDH-Mutant, Grade 4, Diffuse Glioma, Glioblastoma, IDH-Wildtype, Secondary Glioblastoma
- Trial name
- NCT04145115
- Testing
- Ipilimumab, Magnetic Resonance Imaging, Nivolumab
- Where
- 414 sites in United States, Puerto Rico
- Volunteers
- 37 people
- Sponsor
- National Cancer Institute (NCI)
Glioma, Glioblastoma
Sub-lobectomy for IDH Wild-type and TERT Promoter Mutant Glioblastoma
Glioblastoma is recognized as the most common and aggressive form of primary malignant brain tumor, with treatment options that are limited and prognosis that is extremely poor, showing median progression-free survival of 12…
- Trial name
- NCT06368934
- Testing
- sub-lobectomy, imaging total resection
- Where
- China
- Volunteers
- 326 people
- Sponsor
- Huashan Hospital
Glioma
A Study to Evaluate the Safety and Efficacy of L19TNF With Alkylating Chemotherapy for Patients With Recurrent IDH-mutant Astrocytoma or Oligodendroglioma
The purpose of this study is to explore the safety and efficacy of the antibody-cytokine fusion protein L19TNF alone or in combination with alkylating chemotherapy in patients with recurrent IDH mutant glioma.
- Trial name
- IMAGLIO (NCT07120984)
- Testing
- L19TNF, L19TNF and TMZ, L19TNF and CCNU
- Volunteers
- 52 people
- Sponsor
- Philogen S.p.A.
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.
Anaplastic Astrocytoma, Anaplastic Oligoastrocytoma
Proton Beam or Intensity-Modulated Radiation Therapy in Preserving Brain Function in Patients With IDH Mutant Grade II or III Glioma
This randomized phase II clinical trial studies the side effects and how well proton beam or intensity-modulated radiation therapy works in preserving brain function in patients with IDH mutant grade II or III glioma.
- Conditions
- Anaplastic Astrocytoma, Anaplastic Oligoastrocytoma, Anaplastic Oligodendroglioma, Diffuse Astrocytoma
- Trial name
- NCT03180502
- Testing
- Biospecimen Collection, Intensity-Modulated Radiation Therapy, Laboratory Biomarker Analysis
- Where
- 34 sites in United States
- Volunteers
- 120 people
- Sponsor
- NRG Oncology
Glioma, Glioma (Diagnosis)
GliomaAI-Astro4: MRI-Based Detection of IDH Mutant Astrocytoma Grade 4
The goal of this observational study is to learn whether an artificial intelligence system called GliomaAI-Astro4 can help detect a specific molecular type of brain tumour called IDH mutant Astrocytoma Grade 4 using routine MRI…
- Conditions
- Glioma, Glioma (Diagnosis), Astrocytoma, Astrocytoma, Grade IV
- Trial name
- GliomaAI-A4 (NCT07673679)
- Testing
- GliomaAI-Astro4
- Where
- India
- Volunteers
- 1,372 people
- Sponsor
- Deep Learning Institute of Radiological Sciences
Glioblastoma (GBM), Diffuse Midline Glioma (DMG)
Intrathecal Azacitidine and Nivolumab in Patients With Recurrent High-grade Glioma
This is a single-arm open-label phase 1 dose escalation/expansion trial assessing the safety and efficacy of concurrent intrathecal azacitidine and intrathecal nivolumab in recurrent high-grade glioma.
- Conditions
- Glioblastoma (GBM), Diffuse Midline Glioma (DMG), Astrocytoma, IDH-Mutant, Grade 4, Diffuse Hemispheric Glioma, H3 G34-Mutant
- Trial name
- NCT06896110
- Testing
- Nivolumab, Azacitidine (AZA), lumbar puncture
- Where
- United States
- Volunteers
- 34 people
- Sponsor
- Andrew P. Groves
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.
Neurological Cancer
ASTX727 in Recurrent/Progressive Non-enhancing IDH Mutant Gliomas
this research study is evaluating the highest dose of ASTX727 that can be administered safely to recurrent/progressive non-enhancing IDH mutant gliomas patients.
- Trial name
- NCT03922555
- Testing
- ASTX727
- Where
- 3 sites in United States
- Volunteers
- 18 people
- Sponsor
- Massachusetts General Hospital
Diffuse Astrocytoma, IDH-Mutant, Glioblastoma, IDH-wildtype
Safety and Efficacy of NEO212 in Patients With Astrocytoma IDH-mutant, Glioblastoma IDH-wildtype or Brain Metastasis
This multi-site, Phase 1/2 clinical trial is an open-label study to identify the safety, pharmacokinetics, and efficacy of a repeated dose regimen of NEO212 alone for the treatment of patients with radiographically-confirmed…
- Conditions
- Diffuse Astrocytoma, IDH-Mutant, Glioblastoma, IDH-wildtype, Brain Metastases, Adult, Cervical Cancer
- Trial name
- NCT06047379
- Testing
- NEO212 Oral Capsule, Ipilimumab, Pembrolizumab
- Where
- 8 sites in United States
- Volunteers
- 134 people
- Sponsor
- Neonc Technologies, Inc.