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Study of Ribociclib and Everolimus in HGG and DIPG or Ribociclib and Temozolomide in DHG, H3G34-mutant

NCT05843253 · Status: RECRUITING · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 120

Last updated 2026-04-22

No results posted yet for this study

Summary

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 patients diagnosed with HGG/DIPG or DHG H3G34-mutant.

Conditions

Interventions

DRUG

Ribociclib

Ribociclib PO qd on days 1-21

DRUG

Everolimus

Everolimus PO qd on days 1-28

DRUG

Temozolomide (TMZ)

Temozolomide PO qd on days 1-5 for the first 13 cycles

Sponsors & Collaborators

  • Novartis

    collaborator INDUSTRY

  • Nationwide Children's Hospital

    lead OTHER

Principal Investigators

  • Margot Lazow, MD · Nationwide Children's Hospital

  • Maryam Fouladi, MD · Nationwide Children's Hospital

Study Design

Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
12 Months
Max Age
39 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2024-08-22
Primary Completion
2029-08-31
Completion
2034-08-28
FDA Drug
Yes

Countries

  • United States
  • Australia
  • Canada
  • Germany
  • Netherlands
  • New Zealand
  • United Kingdom

Study Locations

More Related Trials

Entities

Drugs
Diseases
Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05843253 on ClinicalTrials.gov