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Checkpoint Inhibitor

Pembrolizumab for Glioblastoma

Phase 2
Waitlist Available
Led By Mark R Gilbert, M.D.
Research Sponsored by National Cancer Institute (NCI)
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up one year
Awards & highlights

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.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~one year
This trial's timeline: 3 weeks for screening, Varies for treatment, and one year for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
One-year Overall Survival (OS) Rate
Secondary outcome measures
Ancillary Treatment Cohort: Number of Adverse Events Grades 2-5, Unrelated, Unlikely, Possibly, Probably, and/or Definitely Related to Pembrolizumab
Mean Symptom Interference Using the MD Anderson Symptom Inventory-Brain Tumor Module (MDASI-BT).
Mean Symptom Severity Using the MD Anderson Symptom Inventory-Brain Tumor Module (MDASI-BT).
+6 more
Other outcome measures
Number of Participants With Serious and/or Non-serious Adverse Events Assessed by the Common Terminology Criteria for Adverse Events (CTCAE v5.0)

Side effects data

From 2024 Phase 2 trial • 57 Patients • NCT03004183
21%
Fatigue
13%
Nausea
11%
Back pain
9%
Shortness of Breath
9%
Anemia
9%
Abdominal pain
9%
Diarrhea
7%
Pneumonia
7%
Kidney Injury and/or Infection
7%
Dyspnea
7%
Weight Loss
5%
Malnutrition, Hypercalcemia and Weakness
5%
Pneumothorax
5%
Intractable pain, back pain, hip pain
5%
Activated partial thromboplastin time prolonged
4%
Pleural effusion
4%
Atrial fibrillation with rapid ventricular response
2%
Thrombocytopenia
2%
Respiratory failure
2%
Skin rash
2%
colitis
100%
80%
60%
40%
20%
0%
Study treatment Arm
Single Arm

Trial Design

4Treatment groups
Experimental Treatment
Placebo Group
Group I: 3/Temozolomide+Pembrolizumab+ Heat Shock Protein Peptide Complex-96 (HSPPC-96) VaccineExperimental Treatment3 Interventions
Temozolomide+Pembrolizumab+ HSPPC96 Vaccine
Group II: 2/Temozolomide+PembrolizumabExperimental Treatment3 Interventions
Temozolomide+Pembrolizumab
Group III: 1/Temozolomide + Pembrolizumab + Radiation TherapyExperimental Treatment3 Interventions
Standard treatment with experimental treatment (pembro) added.
Group IV: 4/Temozolomide+Pembrolizumab+ PlaceboPlacebo Group3 Interventions
Temozolomide+Pembrolizumab+ Placebo
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Surgery
2000
Completed Phase 3
~2550
Pembrolizumab
2017
Completed Phase 2
~2010
HSPPC-96
2005
Completed Phase 2
~260
Temozolomide
2010
Completed Phase 3
~1930

Find a Location

Who is running the clinical trial?

National Cancer Institute (NCI)Lead Sponsor
13,657 Previous Clinical Trials
40,933,577 Total Patients Enrolled
322 Trials studying Glioblastoma
23,025 Patients Enrolled for Glioblastoma
Mark R Gilbert, M.D.Principal InvestigatorNational Cancer Institute (NCI)
8 Previous Clinical Trials
3,369 Total Patients Enrolled
5 Trials studying Glioblastoma
3,325 Patients Enrolled for Glioblastoma

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Pembrolizumab is most commonly administered for what purpose?

"Pembrolizumab is an immunotherapy drug that can be used to treat various cancers, including melanoma, microsatellite instability high, and malignant neoplasms."

Answered by AI

How many people have been chosen to participate in this experiment?

"As of October 14th, 2022, this study is not recruiting patients. The trial was initially posted on September 21st, 2017. There are 458 other clinical trials actively recruiting patients with glioblastoma and 1212 studies for Pembrolizumab that are looking for participants."

Answered by AI

Could you please tell us about other research studies that have utilized Pembrolizumab?

"As of now, 1212 medical studies are underway that concern Pembrolizumab with 147 of them in Phase 3 clinical trials. The majority Houston, Texas based; however, there are a total of 41230 locations running these sorts of tests."

Answered by AI

Does this clinical trial have any open slots for new patients?

"Unfortunately, this study is not taking any more candidates at the moment. The original posting was on September 21st, 2017 but the page was edited as recently as October 14th, 2022. There are 1670 other trials that might be of interest and are currently recruiting patients."

Answered by AI

How many different locations are conducting this trial?

"There are 20 sites where this study is being conducted. Some notable locations include Baylor College of Medicine, Dan L Duncan Cancer Center in Houston, Advocate Lutheran General Hospital in Park Ridge, and Cedars-Sinai Medical Center in Los Angeles."

Answered by AI

When was Pembrolizumab cleared by the FDA?

"While there is some prior data suggesting that Pembrolizumab is safe for human use, there are no studies indicating its efficacy. As such, it received a score of 2."

Answered by AI

Does this research break new ground in the medical field?

"Pembrolizumab is being studied in 1212 active clinical trials, which are located in 3099 cities across 64 countries. The first trial began in 2002 and involved 60 participants. It completed Phase 2 drug approval stage that year. A total of 18819 have been completed since the original study."

Answered by AI
Recent research and studies
clinicaltrials.govStudy
Radiation Therapy Plus Temozolomide and Pembrolizumab With and Without HSPPC-96 in Newly Diagnosed Glioblastoma (GBM)
Mark Gilbert, M.D. 2017. "Radiation Therapy Plus Temozolomide and Pembrolizumab With and Without HSPPC-96 in Newly Diagnosed Glioblastoma (GBM)". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT03018288.
~12 spots leftby Apr 2025
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