OncoMatch/Clinical Trials/NCT05843253
Study of Ribociclib and Everolimus in HGG and DIPG or Ribociclib and Temozolomide in DHG, H3G34-mutant
Is NCT05843253 recruiting? Yes, currently enrolling (Jun 2026). This Phase 2 trial studies multiple treatments including Ribociclib and Everolimus for high grade glioma.
Treatment: Ribociclib · Everolimus · Temozolomide (TMZ) — 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.
Check if I qualifyExtracted eligibility criteria
Treatments studied
Targeted therapy
Other
Cancer type
Glioblastoma
Diffuse Intrinsic Pontine Glioma
Biomarker criteria
Required: CDK4 amplification
Amplification of CDK4
Required: CDK6 amplification
Amplification of CDK6
Required: CDKN2A deletion
Deletion of CDKN2A
Required: CDKN2B deletion
Deletion of CDKN2B
Required: CDKN2C deletion
Deletion of CDKN2C
Required: CCND1 amplification
Amplification of CCND1
Required: CCND2 amplification
Amplification of CCND2
Required: PTEN deletion
Deletion of PTEN
Required: PTEN mutation
Mutation of PTEN
Required: PIK3CA mutation
Mutation of PIK3CA
Required: PIK3CA amplification
Amplification of PIK3CA
Required: PIK3R1 mutation
Mutation of PIK3R1
Required: TSC1 deletion
Deletion of TSC1
Required: TSC1 mutation
Mutation of TSC1
Required: TSC2 deletion
Deletion of TSC2
Required: TSC2 mutation
Mutation of TSC2
Required: H3F3A (H3 K27M) H3G34R
For Stratum E: H3G34 (R/V) mutation
Required: H3F3A (H3 K27M) H3G34V
For Stratum E: H3G34 (R/V) mutation
Excluded: RB1 loss
Patients with evidence of homozygous (biallelic) RB1 loss by sequencing are excluded from TarGeT-A
Disease stage
Required: Stage WHO GRADE 3, WHO GRADE 4 (WHO)
All other HGGs must be WHO grade 3 or 4.
Demographics
Prior therapy
Must have received: radiation therapy (photon RT, proton RT) — HGG
Patients must have received photon or proton RT.
Cannot have received: anticancer therapy (other than surgery, RT, dexamethasone, temozolomide with RT, bevacizumab >21 days prior)
No other prior anticancer therapy for HGG will be allowed.
Lab requirements
Blood counts
ANC ≥ 1000/mm3; Platelet count ≥ 100,000/mm3 (transfusion independent); Hemoglobin >8 g/dL (may be transfused)
Kidney function
Creatinine clearance or radioisotope GFR ≥ 70ml/min/1.73 m2 OR age/gender-based maximum serum creatinine
Liver function
Total bilirubin ≤ 1.5x ULN for age; AST(SGOT)/ALT(SGPT) ≤ 3x ULN; serum albumin ≥ 2g/dL
Cardiac function
Ejection fraction ≥ 50% by echocardiogram; QTc ≤ 450 msec (Bazett formula)
Adequate Bone Marrow Function... Adequate Renal Function... Adequate Liver Function... Adequate Cardiac Function...
Structured fields extracted by AI. May contain errors — verify against the official protocol.
US trial sites
- Children's Hospital Colorado · Aurora, Colorado
- Children's National Medical Center · Washington D.C., District of Columbia
- Ann & Robert H. Lurie Children's Hospital of Chicago · Chicago, Illinois
- Dana-Farber Cancer Institute · Boston, Massachusetts
- C.S. Mott Children's Hospital · Ann Arbor, Michigan
Showing up to 5 US sites.
See all sites on ClinicalTrials.gov →Frequently asked questions
Is NCT05843253 currently recruiting?
Yes, this trial is currently recruiting patients.
Are there prior therapy exclusions?
Yes. Prior anticancer therapy (other than surgery, RT, dexamethasone, temozolomide with RT, bevacizumab >21 days prior) disqualifies patients from enrollment.
Does this trial require CDK4?
Yes, CDK4 amplification is a required biomarker for enrollment.
Does this trial require CDK6?
Yes, CDK6 amplification is a required biomarker for enrollment.
Does this trial require CDKN2A?
Yes, CDKN2A deletion is a required biomarker for enrollment.
Are patients with RB1 alterations eligible?
No. RB1 loss is an exclusion criterion.
What disease stage is eligible?
Stage WHO GRADE 3 or WHO GRADE 4 is required.
Is there an age limit?
Yes. Patients must be 39 years or younger and at least 1 years old.
Could you qualify for this trial?
Enter your biomarker results to see how this trial's eligibility criteria match your specific cancer profile.
Check if I qualify