Personalized NeoAntigen Cancer Vaccine w RT Plus Pembrolizumab for Patients With Newly Diagnosed GBM
Status:
Recruiting
Trial end date:
2026-01-01
Target enrollment:
Participant gender:
Summary
This research study is studying a new type of vaccine as a possible treatment for patients
with glioblastoma. This research study is a Phase I clinical trial, which tests the safety of
an investigational intervention and also tries to define the appropriate dose of the
intervention to use for further studies. "Investigational" means that the intervention is
being studied and that research doctors are trying to find more about it. It also means that
the FDA (U.S. Food and Drug Administration) has not approved the Personalized NeoAntigen
Cancer Vaccine for any use in patients, including people with glioblastoma.
The purpose of the initial study cohort (Cohort 1) is to determine if it is possible to make
and administer safely a vaccine against glioblastoma by using information gained from
specific characteristics of the participants tumor. It is known that glioblastomas have
mutations (changes in genetic material) that are specific to an individual patient's tumor.
These mutations can cause the tumor cells to produce proteins that appear very different from
the body's own cells. It is possible that these proteins used in a vaccine may induce strong
immune responses, which may help the body fight any tumor cells that could cause the
glioblastoma to come back in the future.
Three additional cohorts (1a, 1b, & 1c) were added to the study following completion of
accrual to the original study cohort (cohort 1). Each new cohort receives NeoVax and
radiation therapy as administered to cohort 1 and will also receive pembrolizumab: cohort 1a
patients will start pembrolizumab w/in 2 weeks after start of RT, and continue every 3 weeks
for up to 2 years; cohort 1b patients will start pembrolizumab 2-4 weeks after completion of
NeoVax priming, and continue every 3 weeks for up to 2 years; cohort 1c patients will receive
a single dose of pembrolizumab administered within 2 weeks after start of RT, re-start 2-4
weeks after completion of NeoVax priming, and continue every 3 weeks for up to 2 years. The
rationale for adding these new cohorts is: 1) to assess the safety and feasibility of NeoVax
when administered with pembrolizumab; and 2) to determine if the timing of anti-PD-1
administration impacts the immunogenicity of NeoVax.
An additional sub-study cohort (1d) is being added for patients whose tumor is
MGMT-methylated. Cohort 1d will enroll patients with tumors for which the MGMT status is
methylated or partially methylated; patients on cohort 1d will receive standard daily
temozolomide during radiation and as adjuvant therapy for up to six cycles following
completion of radiation therapy. The rationale for adding cohort 1d is to determine the
safety and feasibility of NeoVax when administered with pembrolizumab and temozolomide.
Phase:
Phase 1
Details
Lead Sponsor:
Dana-Farber Cancer Institute
Collaborators:
Accelerate Brain Cancer Cure Merck Sharp & Dohme Corp. National Institutes of Health (NIH) The Ben & Catherine Ivy Foundation