Study to Evaluate Safety, Tolerability, and Optimal Dose of Candidate GBM Vaccine VBI-1901 in Recurrent GBM Subjects

PHASE1/PHASE2RecruitingINTERVENTIONAL
Enrollment

98

Participants

Timeline

Start Date

December 6, 2017

Primary Completion Date

July 31, 2025

Study Completion Date

August 31, 2025

Conditions
Glioblastoma Multiforme
Interventions
BIOLOGICAL

VBI-1901

The vaccine is formulated with GM-CSF adjuvant and administered intradermally (ID) or with AS01B adjuvant and administered intramuscularly (IM) to patients with recurrent GBM.

DRUG

Carmustine

Treatment with carmustine intravenously at a dose of 150 mg/m² on Day 1 and every 6 weeks until the earlier of disease progression or intolerable toxicity.

DRUG

Lomustine

Treatment with lomustine given orally at a dose of 110 mg/m² (up to a maximum dose of 200 mg) on Day 1 and every 6 weeks until the earlier of disease progression or intolerable toxicity.

Trial Locations (12)

10032

RECRUITING

The Neurological Institute of New York Columbia University Medical Center, New York

33176

RECRUITING

Miami Cancer Institute, Miami

37232

RECRUITING

Vanderbilt University Medical Center, Nashville

77030

RECRUITING

MD Anderson Cancer Center, Houston

90095

RECRUITING

University of California, Los Angeles Neuro-Oncology Program, Los Angeles

92093

RECRUITING

University of California, San Diego, La Jolla

92868

RECRUITING

University of California, Irvine, Irvine

94305

RECRUITING

Stanford, Stanford

98122

TERMINATED

Providence - Swedish Medical Center, Seattle

02114

RECRUITING

Massachusetts General Hospital, Boston

02215

RECRUITING

Dana-Farber Cancer Institute, Boston

07450

RECRUITING

The Valley Hospital - Neurosurgeons of New Jersey, Ridgewood

All Listed Sponsors
lead

VBI Vaccines Inc.

INDUSTRY