ClinicaliQ Trial Snapshot
- Study of Ribociclib and Everolimus in HGG and DIPG or Ribociclib and Temozolomide in DHG, H3G34-mutant — Recruiting • Phase II • Oncology • NCT05843253.
- What is being tested: This trial investigates ribociclib (CDK4/6 inhibitor) combined with either everolimus or temozolomide in pediatric and young adult patients with newly diagnosed high-grade gliomas (HGG), DIPG, and H3G34-mutant tumours, targeting specific genetic pathway alterations in cell cycle regulation.
- Patient eligibility overview: The study includes children and young adults with newly diagnosed high-grade gliomas (including DIPG and diffuse hemispheric gliomas) that harbour specific genetic mutations affecting cell cycle and related pathways, stratified by tumour type and molecular profile.
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What This Trial Is Studying
The goal of this study is to determine the efficacy of the 1) ribociclib and everolimus to treat pediatric and young adult patients newly diagnosed with a high-grade glioma (HGG), including DIPG, that have genetic changes in pathways (cell cycle, PI3K/mTOR) that these drugs target or 2) ribociclib and temozolomide to treat pediatric and young adult patients newly diagnosed with diffuse hemispheric glioma (DHG), H3G34-mutant. The main question the study aims to answer is whether the combinations of ribociclib and everolimus or ribociclib and temozolomide can prolong the life of…
Eligibility Snapshot
- TarGeT-A study strata definitions Part1: Initial Feasibility Study for the combination of ribociclib PfOS formulation with everolimus: Enrollment on this cohort will be limited to patients aged 21 days prior to enrollment. No other prior anticancer therapy for HGG will be allowed. * Patients must have received photon or proton RT. * Patients must have started RT < 42 calendar days from initial diagnosis defined as the date of diagnostic biopsy or resection. If a patient underwent 2 upfront surgeries (e.g., biopsy then resection or debulking), this is the date of the second surgery. * RT delivered via photon or proton beam, must have been administered at a standard dose including (54 Gy in 30 fractions for DIPG, 54-59.4 Gy in 30-33 fractions), 45 Gy-54 Gy for primary spinal disease, and/or 36 Gy-39.6 Gy craniospinal for patients with spinal or leptomeningeal metastatic disease with supplemental boost to 45-54 Gy for metastasis within the thecal sac and 54 Gy-60 Gy for intracranial metastasis. Any variances in the radiotherapy dose within 10% of the standard doses outlined above will be discussed with the Sponsor-Investigator to confirm eligibility prior to study enrollment. * Patients must enroll and start treatment No later than…
Use the source registry for the full inclusion and exclusion criteria before discussing referral or enrolment.