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

PHASE2RecruitingINTERVENTIONAL
Enrollment

120

Participants

Timeline

Start Date

August 22, 2024

Primary Completion Date

August 28, 2028

Study Completion Date

August 28, 2034

Conditions
High Grade GliomaDiffuse Intrinsic Pontine GliomaAnaplastic AstrocytomaGlioblastomaGlioblastoma MultiformeDiffuse Midline Glioma, H3 K27M-MutantMetastatic Brain TumorWHO Grade III GliomaWHO Grade IV GliomaDiffuse Hemispheric Glioma, H3 G34-Mutant
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

Trial Locations (18)

2031

NOT_YET_RECRUITING

Sydney Children's Hospital, Randwick

3720

NOT_YET_RECRUITING

Princess Máxima Center, Utrecht

4101

NOT_YET_RECRUITING

Queensland Children's Hospital, South Brisbane

6000

NOT_YET_RECRUITING

Perth Children's Hospital, Perth

19104

NOT_YET_RECRUITING

Children's Hospital of Philadelphia, Philadelphia

20010

RECRUITING

Children's National Medical Center, Washington D.C.

27708

NOT_YET_RECRUITING

Duke University Health System, Durham

43235

RECRUITING

Nationwide Children's Hospital, Columbus

45229

RECRUITING

Cincinnati Children's Hospital Medical Center, Cincinnati

60611

NOT_YET_RECRUITING

Ann & Robert H. Lurie Children's Hospital of Chicago, Chicago

69120

NOT_YET_RECRUITING

Hopp Children's Cancer Center at NCT Heidelberg (KiTZ), Heidelberg

77030

RECRUITING

Texas Children's Hospital, Houston

80045

NOT_YET_RECRUITING

Children's Hospital Colorado, Aurora

98105

NOT_YET_RECRUITING

Seattle Children's Hospital, Seattle

02215

NOT_YET_RECRUITING

Dana-Farber Cancer Institute, Boston

M5G1X8

NOT_YET_RECRUITING

The Hospital for Sick Children (SickKids), Toronto

H4A3J1

NOT_YET_RECRUITING

Montreal Children's Hospital, Montreal

WC1N 3JH

NOT_YET_RECRUITING

Great Ormond Street Hospital, London

Sponsors

Collaborators (1)

All Listed Sponsors
collaborator

Novartis

INDUSTRY

lead

Nationwide Children's Hospital

OTHER

NCT05843253 - Study of Ribociclib and Everolimus in HGG and DIPG or Ribociclib and Temozolomide in DHG, H3G34-mutant | Biotech Hunter | Biotech Hunter