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NCT07206849
A Phase 2 Study of Tovorafenib in Pediatric and Young Adult Patients Newly Diagnosed With High-Grade Glioma (HGG), Including Diffuse Intrinsic Pontine Glioma (DIPG), Which Harbor Alterations in the Mitogen-Activated Protein Kinase (MAPK) Pathway
Phase 2 trial testing Tovorafenib in High Grade Glioma (HGG) of the Brain With BRAF Aberration in 79 participants. Not yet recruiting.
1 May 2030
Quick facts
| Lead sponsor | Nationwide Children's Hospital |
|---|---|
| Phase | Phase 2 |
| Status | Not yet recruiting |
| Study type | INTERVENTIONAL |
| Allocation | non randomized |
| Design | parallel |
| Masking | none |
| Primary purpose | treatment |
| Enrollment | 79 |
| Start date | 1 May 2026 |
| Primary completion | 1 May 2030 |
| Estimated completion | 1 May 2037 |
Drugs / interventions tested
- Tovorafenib (TOVORAFENIB) — full drug profile →
Conditions studied
- High Grade Glioma (HGG) of the Brain With BRAF Aberration — all drugs for High Grade Glioma (HGG) of the Brain With BRAF Aberration →
- High Grade Glioma (III or IV) — all drugs for High Grade Glioma (III or IV) →
- Diffuse Intrinsic Pontine Glioma — all drugs for Diffuse Intrinsic Pontine Glioma →
- High Grade Glioma — all drugs for High Grade Glioma →
Sponsor
Nationwide Children's Hospital
Who can join
Adults 12 Months to 39, any sex, with High Grade Glioma (HGG) of the Brain With BRAF Aberration or High Grade Glioma (III or IV). Patients with the condition only — healthy volunteers not accepted.
What's being measured
Primary outcomes are the specific endpoints the trial is designed to prove or disprove.
-
Progression Free Survival Stratum A
Time frame: 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.
Sponsor's own description
The goal of this study is to determine the efficacy of the study drugs tovorafenib to treat pediatric and young adult patients newly diagnosed with a high-grade glioma (HGG), including DIPG, that have genetic changes in pathways (MAPK) that this drug targets. The main question the study aims to answer is whether tovorafenib can prolong the life of patients diagnosed with HGG, including DIPG.
Publications & conference data
1 peer-reviewed publication reference this trial (live from Europe PMC):
-
Targeted therapies in pediatric oncology: A start.
Shah N. · · 2026 · PMID 41994561 · DOI 10.1016/j.omton.2026.201146
Verify or expand the search:
- PubMed search for NCT07206849
- Europe PMC full search
- ASCO Meeting Library
- ESMO Meeting Library
- bioRxiv preprints
- medRxiv preprints
- Google Scholar
Related trials
Other trials of Tovorafenib
Trials testing the same drug.
- NCT06965114 — Testing the Combination of Anti-cancer Drugs, Tovorafenib Plus Rituximab, in Patients With Hairy Cell Leukemia · Phase 1, PHASE2 · recruiting
- NCT07441707 — A Study to Assess a Medicine Called Tovorafenib in Japanese Children and Young Adults With Brain Tumours · Phase 1 · not yet recruiting
- NCT05828069 — A Study With Tovorafenib (DAY101) as a Treatment Option for Progressive, Relapsed, or Refractory Langerhans Cell Histioc · Phase 2 · recruiting
- NCT06381570 — Pilot Study of Vinblastine and Tovorafenib in Pediatric Patients With Recurrent/Progressive RAF Altered Low Grade Glioma · EARLY_PHASE1 · recruiting
- NCT05465174 — Tovorafenib for Treatment of Craniopharyngioma in Children and Young Adults · Phase 2 · recruiting
Other recruiting trials for High Grade Glioma (HGG) of the Brain With BRAF Aberration
Currently open trials in the same condition.
- NCT04201457 — A Trial of Dabrafenib, Trametinib and Hydroxychloroquine for Patients With Recurrent LGG or HGG With a BRAF Aberration · Phase 1, PHASE2 · active not recruiting
Other Nationwide Children's Hospital trials
Trials by the same sponsor.
- NCT07035912 — Novel PIONEER© Protocol: RCT · NA · not yet recruiting
- NCT07435792 — TetraGraph to Evaluate Onset and Recovery Times of Rocuronium · NA · not yet recruiting
- NCT07026942 — Phase I/II Clinical Trial of Universal Donor CD33 CAR Natural Killer Cells for AML · Phase 1, PHASE2 · not yet recruiting
- NCT06795126 — Little NIRVANA for Pediatric Pain and Anxiety · NA · enrolling by invitation
- NCT06854991 — Healthy Children and Virtual Reality Mediation of Simulated Pain · NA · enrolling by invitation
Verify against primary sources
- ClinicalTrials.gov — authoritative US registry record
- WHO ICTRP — international registry index
- EU Clinical Trials Register
- Sponsor press releases (Google)
- Trial protocol + status: ClinicalTrials.gov NCT07206849 (US National Library of Medicine, public domain)
- Publications: Europe PMC API search by NCT ID, retrieved 10 June 2026
- Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
- Sponsor: as reported to ClinicalTrials.gov by Nationwide Children's Hospital
- Last refreshed: 3 April 2026
Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT07206849.
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing