Residual or Recurrent Grade 2 IDH Mutant GliomaPhase 3NCT06780930

Phase 3 Study of Vorasidenib (S095032/AG-881) in Asian Participants With Residual or Recurrent Grade 2 Glioma With an IDH1 orIDH2 Mutation

A Phase 3 study testing Vorasidenib in people with Residual or Recurrent Grade 2 IDH Mutant Glioma, run by Servier at 8 sites in 2 countries.

Active, not recruiting

Under way, not looking for participants. Everyone needed has enrolled. The study is still running.

Official record

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Trial summary

Who is it for?: Ages 12 years and older
Conditions the study is for: Residual or Recurrent Grade 2 IDH Mutant Glioma
What is being tested?: Vorasidenib
Type of treatment: Pill or oral medicine
Could I receive a placebo?: Yes, some participants may receive a placebo
How many people: 57 participants
Where: 8 sitesin 2 countries
Study dates: 18 Oct 2024to 31 Oct 2030
Phase: Phase 3
Are there results?: Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 12 years and older
All sexes
No healthy volunteers
Child, Adult, Older adult

Who may be able to join

Be at least 12 years of age (for Randomized Double-Blind phase) and weigh at least 40 kg.
Have a Karnofsky Performance Scale (KPS) score (for participants ≥16 years of age) or Lansky Play Performance Scale (LPPS) score (for participants <16 years of age) of ≥80%.
Have Grade 2 oligodendroglioma or astrocytoma per WHO 2016 criteria.
Have had at least 1 prior surgery for glioma with the most recent one having occurred at least 1 year (-1 month) and not more than 5 years (+3 months) before randomization, and no other prior anticancer therapy, including radiotherapy and not be in need of immediate chemotherapy or radiotherapy.
Have confirmed IDH1 (IDH1 R132H/C/G/S/L mutation variants tested) or IDH2 (IDH2 R172K/M/W/S/G mutation variants tested) gene mutation status disease
Have MRI-evaluable, measurable, non-enhancing disease, as confirmed by the BIRC for double blind part.

Who cannot join

Have had any prior anticancer therapy other than surgery (biopsy, sub-total resection, gross-total resection) for treatment of glioma including systemic chemotherapy, radiotherapy, vaccines, small-molecules, IDH inhibitors, investigational agents, laser ablation, etc.
Concurrent active malignancy except for a) curatively resected nonmelanoma skin cancer or b) curatively treated carcinoma in situ. Participants with previously treated malignancies are eligible provided they have been disease-free for 3 years at Screening.
Have any other acute or chronic medical or psychiatric condition that may increase the risk associated with the study participation or investigational product administration or may interfere with the interpretation of study results.
Have known active hepatitis B virus (HBV) or hepatitis C virus (HCV) infection, known positive human immunodeficiency virus antibody results, or AIDS-related illness. Participants with a sustained viral response to HCV treatment or immunity to prior HBV infection will be permitted. Participants with chronic HBV that is adequately suppressed by institutional practice will be permitted.

Trial locations and contacts

8 sites in 2 countries.

Country

City, postcode or hospital

8 sites in 2 countries

China6 sites

Tiantan Hospital
Beijing, 100070
Sanbo Brain Hospital, Capital Medical University
Beijing
West China Hospital Sichuan University
Chengdu, Sichuan
Huashan Hospital Fudan University
Shanghai, 200040
The Second People's Hospital of Shenzhen
Shenzhen, Guangdong
The Second Affiliated Hospital of Air Force Military Medical University
Xi'an

Other trials in China

Taiwan2 sites

Taipei Veterans General Hospital
Taipei
Chang Gung Memorial Hospital,
Taoyuan

Other trials in Taiwan

About this study

Official title: A Phase 3, Multicenter, Randomized, Double-blind, Placebo- Controlled Study of Vorasidenib (S095032/AG-881) in Asian Participants With Residual or Recurrent Grade 2 Glioma With an IDH1 or IDH2 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. The study will begin with a safety lead-in (SLI) phase and then will transition to a randomized double-blind placebo-controlled phase. During the study participants will have study visits on day 1 and 15 of the first two cycles, and then only on day 1 of treatment cycles in the frequency included in the study schedule of assessments. All participants will have an end of treatment visit within 7 days after their last dose of study treatment. Approximately 28 (+5) days after treatment has ended, a safety follow-up visit will occur. Study visits may include questionnaires, blood tests, ECG, vital signs, and a physical examination. Beginning at the end of treatment visit participants will be contacted by phone every 6 months for overall survival up to 5 years after the last participant is randomized or until death, withdrawal of consent from overall study participation, lost to follow-up, or sponsor ending the study, whichever occurs first.

Conditions: Residual or Recurrent Grade 2 IDH Mutant Glioma
Being tested: Vorasidenib, Placebo

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

VorasidenibDrug
For oral administration once daily
PlaceboDrug
For oral administration once daily

Study groups in NCT06780930
Study group	Role	What they receive
Randomized Double-Blind Phase: Vorasidenib	Experimental	Not described Receives: Drug: Vorasidenib
Randomized Double-Blind Phase: Placebo	Placebo comparator	Not described Receives: Drug: Placebo

What is being measured

The primary outcome is the main question the study is designed to answer.

Progression-Free Survival (PFS)
The time from date of randomization to date of first documented radiographic progressive disease (PD), as assessed by the Blinded Independent Review Committee (BIRC), or date of death due to any cause, whichever occurs earlier.
Measured: Approximately 1.5 years

Secondary outcomes (11)

Dose limiting toxicities (DLTs) (for open-label Safety Lead In (SLI) phase)
Measured: Through Cycle 1 (28 days)
Number of adverse events (AEs), serious adverse events (SAEs), and AEs leading to discontinuation or death
Measured: Through the safety follow up visit, 28 days after the last dose (approximately 6.5 years)
Severity of AEs
Measured: Through the safety follow up visit, 28 days after the last dose (approximately 6.5 years)
Time-To-Next-Intervention (TTNI)
The time from randomization to the initiation of the first subsequent anticancer therapy (including vorasidenib, for participants randomized to placebo who subsequently cross over) or death due to any cause.
Measured: Through the PFS Follow-up (approximately 6.5 years)
Tumor Growth Rate (TGR) as assessed by volume
Defined as the percentage change in tumor volume every 6 months
Measured: Through the PFS Follow-up (approximately 6.5 years)
Objective response
Best overall response of Complete Response (CR), Partial Response (PR), or Minor Response (MR)
Measured: Through the PFS Follow-up (approximately 6.5 years)
Time to response
The time from the date of randomization to the date of first documented CR, PR, or MR for responders as assessed by the Investigator and by the BIRC
Measured: Through the PFS Follow-up (approximately 6.5 years)
Duration of response
The time from the date of first documented CR, PR, or MR to the earlier of the date of death due to any cause or first documented radiographic PD as assessed by the Investigator and by the BIRC
Measured: Through the PFS Follow-up (approximately 6.5 years)
Overall survival
The time from the date of randomization to the date of death due to any cause
Measured: Through the Overall Survival Follow-up (approximately 6.5 years)
Plasma concentrations of vorasidenib
Measured: Through the end of treatment visit, within 7 days after the last dose (approximately 6.5 years)
Number of seizures by month
Measured: Through the end of treatment visit, within 7 days after the last dose (approximately 6.5 years)

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

18 Oct 202431 Oct 2030

First posted17 Jan 2025
Study start18 Oct 2024
Primary completion7 May 2026
Study completion31 Oct 2030 (estimated)

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Other trials for Residual or Recurrent Grade 2 IDH Mutant GliomaStudies of the same condition, open and under way.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase 3
Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Triple blind
Who is masked: Participant, Care provider, Investigator
Enrolment: 57 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT06780930
Sponsor's protocol ID: CL3-95032-016
Status last verified: Jun 2026
First submitted: 24 Dec 2024
Last updated: 4 Jun 2026
Results posted: No
Data monitoring committee: Yes
FDA-regulated drug: No
FDA-regulated device: No
Individual data sharing: Yes: Qualified scientific and medical researchers can request access to anonymized patient-level and study-level clinical trial data. Access can be requested for all interventional clinical studies: * used for Marketing Authorization (MA) of medicines and new indications approved after 1 January 2014 in the European Economic Area (EEA) or the United States (US). * where Servier is the Marketing Authorization Holder (MAH). The date of the first MA of the new medicine (or the new indication) in one of the EEA Member States will be considered for this scope. In addition, access can be requested for all interventional clinical studies in patients: * sponsored by Servier * with a first patient enrolled as of 1 January 2004 onwards * for New Chemical Entity or New Biological Entity (new pharmaceutical form excluded) for which development has been terminated before any Marketing authorization (MA) approval.

Study at a glance

From the registry record, last updated by the sponsor on 4 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: A Phase 3, Multicenter, Randomized, Double-blind, Placebo- Controlled Study of Vorasidenib (S095032/AG-881) in Asian Participants With Residual or Recurrent Grade 2 Glioma With an IDH1 or IDH2 Mutation
ClinicalTrials.gov ID: NCT06780930
Acronym / sponsor ID: CL3-95032-016
Conditions: Residual or Recurrent Grade 2 IDH Mutant Glioma
Phase: Phase 3
Study type: Interventional
Recruitment status: Active, not recruiting
Enrolment: 57 participants (actual)
Lead sponsor: ServierIndustry (pharma, biotech, devices)
Study start: 18 Oct 2024 (actual)
Primary completion: 7 May 2026 (actual)
Study completion: 31 Oct 2030 (estimated)
First posted: 17 Jan 2025 (actual)
Results: Not posted in the source record

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Triple blind (participant, care provider, investigator)
Number of arms: 2

Arm	Type	Receives
Randomized Double-Blind Phase: Vorasidenib	Experimental	Drug: Vorasidenib
Randomized Double-Blind Phase: Placebo	Placebo comparator	Drug: Placebo

Who may qualify

Ages: 12 years and older
Sex: All
Healthy volunteers: Not accepted
Age groups: Child, Adult, Older adult

Key inclusion criteria (6 listed)

Be at least 12 years of age (for Randomized Double-Blind phase) and weigh at least 40 kg.
Have a Karnofsky Performance Scale (KPS) score (for participants ≥16 years of age) or Lansky Play Performance Scale (LPPS) score (for participants <16 years of age) of ≥80%.
Have Grade 2 oligodendroglioma or astrocytoma per WHO 2016 criteria.
Have had at least 1 prior surgery for glioma with the most recent one having occurred at least 1 year (-1 month) and not more than 5 years (+3 months) before randomization, and no other prior anticancer therapy, including radiotherapy and not be in need of immediate chemotherapy or radiotherapy.
Have confirmed IDH1 (IDH1 R132H/C/G/S/L mutation variants tested) or IDH2 (IDH2 R172K/M/W/S/G mutation variants tested) gene mutation status disease

Key exclusion criteria (4 listed)

Have had any prior anticancer therapy other than surgery (biopsy, sub-total resection, gross-total resection) for treatment of glioma including systemic chemotherapy, radiotherapy, vaccines, small-molecules, IDH inhibitors, investigational agents, laser ablation, etc.
Concurrent active malignancy except for a) curatively resected nonmelanoma skin cancer or b) curatively treated carcinoma in situ. Participants with previously treated malignancies are eligible provided they have been disease-free for 3 years at Screening.
Have any other acute or chronic medical or psychiatric condition that may increase the risk associated with the study participation or investigational product administration or may interfere with the interpretation of study results.
Have known active hepatitis B virus (HBV) or hepatitis C virus (HCV) infection, known positive human immunodeficiency virus antibody results, or AIDS-related illness. Participants with a sustained viral response to HCV treatment or immunity to prior HBV infection will be permitted. Participants with chronic HBV that is adequately suppressed by institutional practice will be permitted.

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
VorasidenibFor oral administration once daily	Drug	Randomized Double-Blind Phase: Vorasidenib
PlaceboFor oral administration once daily	Drug	Randomized Double-Blind Phase: Placebo

Primary outcome

Progression-Free Survival (PFS)
Time frame: Approximately 1.5 years
The time from date of randomization to date of first documented radiographic progressive disease (PD), as assessed by the Blinded Independent Review Committee (BIRC), or date of death due to any cause, whichever occurs earlier.

11 secondary outcomes

Dose limiting toxicities (DLTs) (for open-label Safety Lead In (SLI) phase)
Time frame: Through Cycle 1 (28 days)
Number of adverse events (AEs), serious adverse events (SAEs), and AEs leading to discontinuation or death
Time frame: Through the safety follow up visit, 28 days after the last dose (approximately 6.5 years)
Severity of AEs
Time frame: Through the safety follow up visit, 28 days after the last dose (approximately 6.5 years)
Time-To-Next-Intervention (TTNI)
Time frame: Through the PFS Follow-up (approximately 6.5 years)
Tumor Growth Rate (TGR) as assessed by volume
Time frame: Through the PFS Follow-up (approximately 6.5 years)
Objective response
Time frame: Through the PFS Follow-up (approximately 6.5 years)
Time to response
Time frame: Through the PFS Follow-up (approximately 6.5 years)
Duration of response
Time frame: Through the PFS Follow-up (approximately 6.5 years)
Overall survival
Time frame: Through the Overall Survival Follow-up (approximately 6.5 years)
Plasma concentrations of vorasidenib
Time frame: Through the end of treatment visit, within 7 days after the last dose (approximately 6.5 years)
Number of seizures by month
Time frame: Through the end of treatment visit, within 7 days after the last dose (approximately 6.5 years)

Results and safety

This study is still under way. Results are not available in the source record yet.

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 4 Jun 2026.
Individual participant dataSharing planned: Yes. Qualified scientific and medical researchers can request access to anonymized patient-level and study-level clinical trial data. Access can be requested for all interventional clinical studies: * used for Marketing Authorization (MA) of medicines and new indications approved after 1 January 2014 in the European Economic Area (EEA) or the United States (US). * where Servier is the Marketing Authorization Holder (MAH). The date of the first MA of the new medicine (or the new indication) in one of the EEA Member States will be considered for this scope. In addition, access can be requested for all interventional clinical studies in patients: * sponsored by Servier * with a first patient enrolled as of 1 January 2004 onwards * for New Chemical Entity or New Biological Entity (new pharmaceutical form excluded) for which development has been terminated before any Marketing authorization (MA) approval.

Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

The record lists no contact. Use the official record to reach the sponsor.

8 sites in 2 countries: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing Vorasidenib in people with Residual or Recurrent Grade 2 IDH Mutant Glioma, run by Servier at 8 sites in 2 countries.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 6 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: under way, not looking for participants, as of the sponsor's last update on 4 Jun 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 8 sites in China, Taiwan. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Progression-Free Survival (PFS) (time frame: Approximately 1.5 years). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT06780930.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 4 Jun 2026.