Pembrolizumab for Glioblastoma

Phase-Based Progress Estimates
1
Effectiveness
2
Safety
Glioblastoma
Pembrolizumab - Drug
Eligibility
18+
All Sexes
What conditions do you have?
Select

Study Summary

This trial is for people with glioblastoma who will receive the standard treatment of radiation and temozolomide, with or without the addition of pembrolizumab and a vaccine made from their own tumor.

Treatment Effectiveness

Effectiveness Progress

1 of 3

Study Objectives

1 Primary · 0 Secondary · Reporting Duration: one year

one year
To determine whether the one-year overall survival (OS) is improved in newly diagnosed MGMT unmethylated GBM patients treated with RT + TMZ + Pembrolizumab followed by Pembrolizumab + TMZ +/- HSPPC-96 x 6 cycles (1 cycle is 9 weeks) months.

Trial Safety

Safety Progress

2 of 3
This is further along than 68% of similar trials

Side Effects for

Pembrolizumab Second Course
100%Urinary tract infection
100%Parkinsonism
100%Inappropriate antidiuretic hormone secretion
This histogram enumerates side effects from a completed 2021 Phase 3 trial (NCT03066778) in the Pembrolizumab Second Course ARM group. Side effects include: Urinary tract infection with 100%, Parkinsonism with 100%, Inappropriate antidiuretic hormone secretion with 100%.

Trial Design

4 Treatment Groups

2/RT+TMZ + Pembrolizumab
1 of 4
2/RT+TMZ+Pembrolizumab
1 of 4
3/RT+TMZ+Pembrolizumab+HSPPC96 Vaccine
1 of 4
4/RT+TMZ+Pembrolizumab+ Placebo Vaccine
1 of 4
Experimental Treatment
Non-Treatment Group

90 Total Participants · 4 Treatment Groups

Primary Treatment: Pembrolizumab · Has Placebo Group · Phase 2

2/RT+TMZ + PembrolizumabExperimental Group · 2 Interventions: Pembrolizumab, Temozolomide · Intervention Types: Drug, Drug
2/RT+TMZ+PembrolizumabExperimental Group · 2 Interventions: Pembrolizumab, Temozolomide · Intervention Types: Drug, Drug
3/RT+TMZ+Pembrolizumab+HSPPC96 VaccineExperimental Group · 3 Interventions: Pembrolizumab, Temozolomide, HSPPC-96 · Intervention Types: Drug, Drug, Biological
4/RT+TMZ+Pembrolizumab+ Placebo VaccinePlaceboComparator Group · 3 Interventions: Pembrolizumab, Placebo, Temozolomide · Intervention Types: Drug, Other, Drug
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Pembrolizumab
FDA approved
Temozolomide
FDA approved
Vitespen
Not yet FDA approved

Trial Logistics

Trial Timeline

Approximate Timeline
Screening: ~3 weeks
Treatment: Varies
Reporting: one year

Who is running the clinical trial?

National Cancer Institute (NCI)Lead Sponsor
12,991 Previous Clinical Trials
41,298,403 Total Patients Enrolled
301 Trials studying Glioblastoma
22,318 Patients Enrolled for Glioblastoma
Mark R Gilbert, M.D.Principal InvestigatorNational Cancer Institute (NCI)
8 Previous Clinical Trials
3,359 Total Patients Enrolled
5 Trials studying Glioblastoma
3,315 Patients Enrolled for Glioblastoma

Eligibility Criteria

Age 18+ · All Participants · 10 Total Inclusion Criteria

Mark “yes” if the following statements are true for you:
Stereotactic biopsy will not be allowed unless there is plans for second surgery to remove greater than or equal to 80 % of the tumor.
You have a score of 70 or greater on the Karnofsky performance status scale.
You have not received carmustine wafers.

About The Reviewer

Michael Gill preview

Michael Gill - B. Sc.

First Published: October 11th, 2021

Last Reviewed: October 6th, 2022

Michael Gill holds a Bachelors of Science in Integrated Science and Mathematics from McMaster University. During his degree he devoted considerable time modeling the pharmacodynamics of promising drug candidates. Since then, he has leveraged this knowledge of the investigational new drug ecosystem to help his father navigate clinical trials for multiple myeloma, an experience which prompted him to co-found Power Life Sciences: a company that helps patients access randomized controlled trials.