Trial · NCT07215910
Testing Addition of an Anti-cancer Drug, Vorasidenib to Temozolomide, After Radiation for Advanced Brain Cancer
NCT07215910, Phase 3, Recruiting, Alliance for Clinical Trials in Oncology
3 sourcestrials-2026-11-12-0.5.0
Cite this record
ConductScience Library. Testing Addition of an Anti-cancer Drug, Vorasidenib to Temozolomide, After Radiation for Advanced Brain Cancer. Trials, record NCT07215910. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT07215910
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Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Testing Addition of an Anti-cancer Drug, Vorasidenib to Temozolomide, After Radiation for Advanced Brain Cancer
- NCT number
- NCT07215910
- Status
- Recruiting
- Phases
- Phase 3
- Enrollment
- 408 participants, estimated
- Lead sponsor
- Alliance for Clinical Trials in Oncology
- Conditions
- Astrocytoma, IDH-Mutant, Grade 3
- Interventions
Intensity-Modulated Radiation Therapy, Volume Modulated Arc Therapy, Pencil Beam Scanning, Intensity-Modulated Proton Therapy, Temozolomide, Vorasidenib, Placebo Administration, Biospecimen Collection, Magnetic Resonance Imaging, Questionnaire Administration
- First posted
- 2025-10-14
- Last updated
- 2026-11-03
Source ClinicalTrials.gov
Registered outcomes21
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Progression free survival (PFS) by blinded independent central review (BICR) | assessed up to 10 years | This is defined as the time from randomization to the time of documented disease progression, as determined by BICR using the Response Assessment in Neuro-Oncology (RANO) 2.0 criteria or death due to any cause. PFS distributions will be evaluated for each arm and will be graphically and quantitatively compared using Kaplan-Meier methods. These methods will be used to estimate the median PFS as well as 2-, 3-, and 5-year estimates for PFS by treatment arm along with corresponding 95% confidence intervals. Cox proportional hazards models will also be used to assess influential factors on PFS both in the univariate and the multivariable settings. |
| Secondary | Progression free survival (PFS) by local review | up to 10 years | This is defined as the time from randomization to the time of documented disease progression, as determined by local (institutional/investigator) review using the Response Assessment in Neuro-Oncology (RANO) 2.0 criteria or death due to any cause. PFS distributions will be evaluated for each arm and will be graphically and quantitatively compared using Kaplan-Meier methods. These methods will be used to estimate the median PFS as well as 2-, 3-, and 5-year estimates for PFS by treatment arm along with corresponding 95% confidence intervals. Cox proportional hazards models will also be used to assess influential factors on PFS both in the univariate and the multivariable settings. |
| Secondary | Incidence of adverse events (AEs) | Up to 30 days after last dose of study treatment | AEs will be evaluated by treatment regimen. Will be summarized per the National Cancer Institute Common Terminology Criteria for Adverse Events version 5.0 and where toxicities will be defined as AEs that are deemed to be at least possibly treatment-related. The maximum grade for each type of treatment-related AE will be recorded for each patient, and the frequency of each will be summarized by treatment arm. Frequency tables and graphical evaluations of AEs and treatment-related AEs will be summarized and evaluated to assess if there are any patterns or differences in the rates or types of AEs. |
| Secondary | Overall survival (OS) | up to 10 years | This is defined as the time from randomization to the date of death due to any cause. Distributions will be evaluated for each arm using the Kaplan Meier method to calculate 2-, 3-, and 5-year rates along with corresponding 95% confidence intervals. Distributions will be compared between arms using the log rank test. |
| Secondary | Objective response rate (ORR) by blinded independent central review (BICR) | up to 10 years | Will be summarized by treatment arm. This is defined as the proportion of patients with measurable tumor at baseline who achieve a minor, partial, or complete response to therapy divided by the total number of patients with measurable tumor at baseline who were randomized and treated on that arm. Response will be determined by BICR using the Response Assessment in Neuro-Oncology (RANO) 2.0 criteria. Assuming the number of patients who respond to therapy on each arm is binomially distributed, these proportions along with corresponding 95% confidence intervals will be estimated. |
| Secondary | Complete response (CR) + partial response (PR) rate by blinded independent central review (BICR) | up to 10 years | Will be summarized by treatment arm. This is defined as the proportion of patients with measurable tumor at baseline who achieve a partial or complete response to therapy divided by the total number of patients with measurable tumor at baseline who were randomized and treated on that arm. Response will be determined by BICR using the Response Assessment in Neuro-Oncology (RANO) 2.0 criteria. Assuming the number of patients who respond to therapy on each arm is binomially distributed, these proportions along with corresponding 95% confidence intervals will be estimated. |
| Secondary | Time to response by blinded independent central review (BICR) | up to 10 years | Will be summarized by treatment arm. This is defined only for patients with measurable disease at baseline as the time from randomization to the date of response to treatment (minor, partial, or complete), as determined by BICR using the Response Assessment in Neuro-Oncology (RANO) 2.0 criteria. Distributions will be evaluated for each arm using the Kaplan Meier method to calculate 6- and 12-month rates along with corresponding 95% confidence intervals. |
| Secondary | Time to complete response (CR) + partial response (PR) by blinded independent central review (BICR) | up to 10 years | Will be summarized by treatment arm. This is defined only for patients with measurable disease at baseline as the time from randomization to the date of response to treatment (partial or complete), as determined by BICR using the Response Assessment in Neuro-Oncology (RANO) 2.0 criteria. Distributions will be evaluated for each arm using the Kaplan Meier method to calculate 6- and 12-month rates along with corresponding 95% confidence intervals. |
| Secondary | Duration of response by blinded independent central review (BICR) | up to 10 years | Will be summarized by treatment arm for only patients who had measurable disease at baseline and achieved a response (minor, partial, or complete) while on treatment, as determined by BICR using the Response Assessment in Neuro-Oncology (RANO) 2.0 criteria. This is defined as the time from the date of response to treatment (minor, partial, or complete) until the date of progression, as determined by BICR. Distributions will be evaluated for each arm using the Kaplan Meier method to calculate 1- and 2-year rates along with corresponding 95% confidence intervals. |
| Secondary | Duration of Complete response (CR) + partial response (PR) by blinded independent central review (BICR) | up to 10 years | Will be summarized by treatment arm for only patients who had measurable disease at baseline and achieved a response (partial or complete) while on treatment, as determined by BICR using the Response Assessment in Neuro-Oncology (RANO) 2.0 criteria. This is defined as the time from the date of response to treatment (partial or complete) until the date of progression, as determined by BICR. Distributions will be evaluated for each arm using the Kaplan Meier method to calculate 1- and 2-year rates along with corresponding 95% confidence intervals. |
1 to 10 of 21Source ClinicalTrials.gov
See all 21 registered outcomesOutcomes0
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
None in this release.
Results by group0
Each measurement the trial posted, group by group, in the words and numbers it posted.
None in this release.
Participant flow0
How many started, completed or left each group, period by period.
None in this release.
Adverse events0
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
None in this release.
Adverse event totals0
The totals the trial posted for each group.
None in this release.
Papers0
The papers the trial lists on ClinicalTrials.gov.
None in this release.
Grants0
The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.
None in this release.
Trial comparisons0
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
None in this release.
Tests0
The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.
None in this release.
Data dates
The day each source was copied for this release.
Sources 3
- ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
- ClinicalTrials.govNo license stated
- NIH RePORTER's clinical studies and project filesPublic domain
Each source's terms
- ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
- ClinicalTrials.govnone stated
- NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)
ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
For software
Read this trial from software.
The record and each of its lists are JSON, twenty rows a page. No key.
GET https://conductscience.org/api/trials/v1/NCT07215910
GET https://conductscience.org/api/trials/v1/NCT07215910/registered?page=2