Clin2
NCT05843253Possibly a fitRecruiting

Ribociclib plus everolimus or temozolomide for certain brain tumors

High Grade GliomaDiffuse Intrinsic Pontine GliomaAnaplastic AstrocytomaGlioblastomaGlioblastoma MultiformeDiffuse Midline Glioma, H3 K27M-MutantMetastatic Brain TumorWHO Grade III Glioma

Treatments studied

Part of Brain & nervous system, Cancer clinical trials.

This Phase 2 study tests ribociclib with either everolimus or temozolomide, depending on the specific brain tumor type. It may help slow tumor growth in children and young adults whose tumor has specific genetic changes and who have had recent standard radiation therapy.

Summary written for real people, not researchers, by Clin2.

Phase
Phase 2
Enrollment
120 people
Ages
1 year to 39 years
Study type
Interventional

Who can take part

  • Your age must fit the study plan: Part 1 requires under 21 years old; overall study screening is 12 months to 39 years old (on the main screening pathway).
  • You must have a confirmed high-grade glioma (HGG) or DIPG, or a localized HGG with the specific H3G34 (R/V) mutation (for the DHG stratum).
  • Your tumor must have the required genetic (“molecular”) changes on the study’s screening test, and you must not have confirmed RB1 loss in a specific way (called biallelic).
  • You must have finished radiation (photon or proton) recently and be able to start treatment on time after the radiation ends (not too early and not too late).
  • Blood counts, kidney, liver, heart tests, and breathing oxygen levels must meet study thresholds.
  • You must be able to swallow study medicines by mouth (no NG/NJ/G tube) for the ribociclib + everolimus part, and your seizures (if you have them) must be controlled with certain allowed medicines.

View the official record on ClinicalTrials.gov

Quick eligibility check

Answer a few plain-language questions, based on this study's own requirements, to get a preliminary sense of fit.

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