Pembrolizumab and Vorinostat Combined With Temozolomide for Newly Diagnosed Glioblastoma

PHASE1CompletedINTERVENTIONAL
Enrollment

21

Participants

Timeline

Start Date

March 16, 2018

Primary Completion Date

October 18, 2021

Study Completion Date

June 28, 2023

Conditions
GlioblastomaBrain TumorGBM
Interventions
DRUG

Pembrolizumab

200 mg intravenously (IV) every 3 weeks. The dose of pembrolizumab will remain the same throughout study treatment. During the maintenance phase, participants will receive pembrolizumab (for 12 months).

DRUG

Vorinostat

Dose Escalation Level -1 vorinostat 100 mg/day by mouth on days 1-5 every week during radiotherapy starting on first day of radiotherapy and 300 mg/day 1 week on 1 week off after radiotherapy. Level 1:vorinostat 200 mg/day by mouth on day 1-5 every week during radiotherapy, starting on first day of radiotherapy; and 300 mg/day 1 week on 1 week off after radiotherapy. Dose Escalation Level 2: vorinostat 300 mg/day by mouth on days 1-5 every week during radiotherapy, starting on first day of radiotherapy; and 400 mg/day 1 week on 1 week off after radiotherapy.

DRUG

Temozolomide

All participants will receive standard Temozolomide: Temozolomide (chemotherapy) 75 mg/m\^2/day by mouth administered during the course of radiotherapy. Temozolomide will be administered continuously from Day 1 of radiotherapy to the last day of radiation. Maintenance Phase: temozolomide will start 4 weeks (+/- 3 days) after last dose of radiotherapy and will continue for 6 cycles post radiotherapy (150-200 mg/m\^2/day, days 1-5 every 4 weeks) as per standard of care. During the maintenance phase, participants will receive Temozolomide (for the first 6 months).

RADIATION

Radiotherapy

All participants will receive standard radiotherapy: a total dose of 60 Gy administered in daily doses of 2 Gy, typically on a 5 days on / 2 days off schedule over 6 - 7 weeks.

Trial Locations (1)

33612

H. Lee Moffitt Cancer Center and Research Institute, Tampa

All Listed Sponsors
collaborator

Merck Sharp & Dohme LLC

INDUSTRY

lead

H. Lee Moffitt Cancer Center and Research Institute

OTHER

NCT03426891 - Pembrolizumab and Vorinostat Combined With Temozolomide for Newly Diagnosed Glioblastoma | Biotech Hunter | Biotech Hunter