Trial · NCT07206849
Study of Tovorafenib in High-Grade Glioma and Diffuse Intrinsic Pontine Glioma (DIPG)
NCT07206849, Phase 2, Not yet recruiting, Nationwide Children's Hospital
3 sourcestrials-2026-11-12-0.5.0
Cite this record
ConductScience Library. Study of Tovorafenib in High-Grade Glioma and Diffuse Intrinsic Pontine Glioma (DIPG). Trials, record NCT07206849. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT07206849
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Study of Tovorafenib in High-Grade Glioma and Diffuse Intrinsic Pontine Glioma (DIPG)
- NCT number
- NCT07206849
- Status
- Not yet recruiting
- Phases
- Phase 2
- Enrollment
- 79 participants, estimated
- Lead sponsor
- Nationwide Children's Hospital
- Conditions
High Grade Glioma (HGG) of the Brain With BRAF Aberration, High Grade Glioma (III or IV), Diffuse Intrinsic Pontine Glioma, High Grade Glioma, WHO Grade 3 Glioma, WHO Grade 4 Glioma, Metastatic Brain Tumor
- Interventions
- Tovorafenib
- First posted
- 2025-10-03
- Last updated
- 2026-10-20
Source ClinicalTrials.gov
Registered outcomes13
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Progression Free Survival Stratum A | 6 years | Estimate the progression-free survival (PFS) distribution for pediatric and young adult patients (age: ≥12 months and ≤39 years) with newly-diagnosed BRAFV600 mutant HGG (Stratum A) who receive tovorafenib monotherapy post RT compared to molecularly-stratified, matched historical controls. |
| Secondary | Overall Survival Stratum A | 6 years | Estimate the overall survival (OS) distribution for pediatric and young adult patients with newly-diagnosed BRAFV600 mutant HGG (Stratum A) who receive tovorafenib post RT compared to molecularly-stratified, matched historical controls. |
| Secondary | OS Stratum B | 6 years | Describe OS for pediatric and young adult patients newly diagnosed with DIPG or DMG harboring MAPK pathway alterations who receive tovorafenib post RT (Stratum B). |
| Secondary | PFS Stratum B | 6 years | Describe PFS for pediatric and young adult patients newly diagnosed with HGG harboring MAPK alterations not included in Stratum A who receive tovorafenib post RT (Stratum B). |
| Secondary | OS Stratum B | 6 years | Describe the OS for pediatric and young adult patients newly diagnosed with primary spinal cord HGG harboring a MAPK alteration who receive tovorafenib post RT (Stratum B). |
| Secondary | Establish the RP2D of tovorafenib - Stratum C | At the end of Cycle 1 (each cycle is 28 days) | Evaluate the feasibility of administration of tovorafenib post craniospinal RT in pediatric and young adult patients with newly diagnosed, metastatic HGG harboring a MAPK alteration (Stratum C). |
| Secondary | OS Stratum C | 6 years | Describe OS for pediatric and young adult patients with newly-diagnosed, metastatic HGG who receive tovorafenib post RT (Stratum C). |
| Secondary | ORR | 6 years | Evaluate the radiographic objective response rate (ORR \[complete response (CR) + partial response (PR)\]) to tovorafenib treatment post RT in pediatric and young adult patients with newly diagnosed HGG and DIPG/DMG that harbor MAPK alterations (all Strata). |
| Secondary | Number of participants with tovorafenib-related adverse events as assessed by CTCAE v5.0 | From Day 1 of protocol treatment through 30 days following end of protocol treatment | Assess and further characterize the safety and toxicity of post-RT tovorafenib in pediatric and young adult patients newly diagnosed with HGG, including DIPG. This will be achieved by calculating the number of participants with, as well as frequency and severity of, tovorafenib-related Adverse Events as assessed by CTCAE v5.0. |
| Secondary | Correlation between genomic status, recurrence, radiographic response | 6 years | Explore longitudinal associations of genomic, transcriptomic, epigenetic, and/or immunologic alterations of tumor at diagnosis, recurrence, or autopsy with radiographic response, advanced neuro-imaging measures, and patient-reported outcomes. |
1 to 10 of 13Source ClinicalTrials.gov
See all 13 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.
Grants1
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.
| Project | Title | Principal investigators | Organization | Funder | Fiscal years |
|---|---|---|---|---|---|
| R01FD008167 | Phase II, Multi-arm, Molecularly-Guided Umbrella Trial for Children and Young Adults with High-Grade Glioma | FOULADI, MARYAM; LAZOW, MARGOT | RESEARCH INST NATIONWIDE CHILDREN'S HOSP | FOOD AND DRUG ADMINISTRATION | 2025 |
Source NIH RePORTER
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/NCT07206849
GET https://conductscience.org/api/trials/v1/NCT07206849/registered