Study Testing The Safety and Efficacy of Adjuvant Temozolomide Plus TTFields (Optune®) Plus Pembrolizumab in Patients With Newly Diagnosed Glioblastoma (2-THE-TOP)

PHASE2Active, not recruitingINTERVENTIONAL
Enrollment

40

Participants

Timeline

Start Date

February 23, 2018

Primary Completion Date

November 26, 2022

Study Completion Date

September 30, 2025

Conditions
GlioblastomaGlioblastoma, WHO Grade IV
Interventions
DRUG

Temozolomide (TMZ)

Patients will begin treatment with adjuvant TMZ at least 4 weeks but no more than 6 weeks from last dose of concomitant temozolomide or radiation therapy (the latter of the two). A minimum of 6 and maximum of 12 cycles of adjuvant TMZ will be given depending on tolerability and toxicity.

DEVICE

Optune System

Patients will undergo 24-months of planned treatment with Optune therapy.

DRUG

Pembrolizumab

Pembrolizumab will be given intravenously every 3 weeks beginning on Day 1 of Cycle 2 of adjuvant TMZ. Treatment with pembrolizumab every 3 weeks until first disease progression or unacceptable toxicities or 2 years, whichever comes first.

Trial Locations (1)

32610

University of Florida Health, Gainesville

All Listed Sponsors
collaborator

NovoCure Ltd.

INDUSTRY

lead

University of Florida

OTHER

NCT03405792 - Study Testing The Safety and Efficacy of Adjuvant Temozolomide Plus TTFields (Optune®) Plus Pembrolizumab in Patients With Newly Diagnosed Glioblastoma (2-THE-TOP) | Biotech Hunter | Biotech Hunter