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 (May 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
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.
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
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