Comparing tovorafenib to standard chemotherapy for pediatric low-grade glioma

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This Phase 3 trial evaluates the efficacy, safety, and tolerability of tovorafenib monotherapy compared to standard of care chemotherapy in pediatric participants with low-grade glioma that have a specific RAF alteration. Approximately 400 treatment-naïve participants will be randomly assigned to receive either tovorafenib or one of four standard chemotherapy regimens chosen by their investigator. The treatment cycles for tovorafenib will repeat every 28 days unless there is disease progression or unacceptable toxicity. The study aims to determine if tovorafenib provides a better treatment option than traditional chemotherapy for this patient population.

Why it matters

Who can join: the full rules

Inclusion Criteria:

* Less than 25 years of age with LGG with known activating RAF alteration.
* Histopathologic diagnosis of glioma or glioneuronal tumor.
* At least one measurable lesion as defined by RANO criteria.
* Meet indication for first-line systemic therapy.

Exclusion Criteria:

* Participant has any of the following tumor-histological findings:

  1. Schwannoma
  2. Subependymal giant cell astrocytoma (Tuberous Sclerosis)
  3. Diffuse intrinsic pontine glioma, even if histologically diagnosed as World Health Organization (WHO) Grade I-II
* Participant's tumor has additional pathogenic molecular alterations, including but not limited to a) isocitrate dehydrogenase (IDH) 1/2 mutation, b) Histone H3 mutation, and c) neurofibromatosis Type 1 (NF-1) loss of function alteration.
* Known or suspected diagnosis of NF-1/ neurofibromatosis Type 2 (NF-2).
* Prior or ongoing nonsurgical anticancer therapy for this indication (eg, chemotherapy, oral/IV targeted therapy) including radiation.

Where it's running

• Children's of Alabama
  Birmingham, Alabama, United States Recruiting
• Phoenix Children's Hospital
  Phoenix, Arizona, United States Recruiting
• Children's Hospital Los Angeles
  Los Angeles, California, United States Recruiting
• Children's Hospital of Orange County Main Campus - Orange
  Orange, California, United States Recruiting
• Packard Children's Hospital Stanford
  Palo Alto, California, United States Recruiting
• UCSF Benioff Children's Hospital
  San Francisco, California, United States Recruiting

+88 more sites. See ClinicalTrials.gov for the full list.

Study contacts

• Study coordinator: Day One Clinical Trials Information
• Email: clinicaltrials@dayonebio.com
• Phone: 650-484-0899

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.