Pembrolizumab for Glioblastoma

Phase-Based Progress Estimates
1
Effectiveness
2
Safety
Baylor University Medical Center, Dallas, TX
Glioblastoma
Pembrolizumab - Drug
Eligibility
18+
All Sexes
Eligible conditions
Select

Study Summary

Radiation Therapy Plus Temozolomide and Pembrolizumab With and Without HSPPC-96 in Newly Diagnosed Glioblastoma (GBM)

See full description

Treatment Effectiveness

Study Objectives

This trial is evaluating whether Pembrolizumab will improve 1 primary outcome in patients with Glioblastoma. Measurement will happen over the course of 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

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

This trial requires 90 total participants across 4 different treatment groups

This trial involves 4 different treatments. Pembrolizumab is the primary treatment being studied. Participants will be divided into 3 treatment groups. Some patients will receive a placebo treatment. The treatments being tested are in Phase 2 and have already been tested with other people.

2/RT+TMZ + PembrolizumabStandard treatment with experimental treatment (pembro) added
2/RT+TMZ+PembrolizumabStandard treatment with experimental treatment (pembro) added
3/RT+TMZ+Pembrolizumab+HSPPC96 VaccineStandard treatment with experimental treatment (pembro+ vaccine) added
4/RT+TMZ+Pembrolizumab+ Placebo VaccineStandard treatment with experimental treatment and placebo added
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
This trial has the following approximate timeline: 3 weeks for initial screening, variable treatment timelines, and roughly one year for reporting.

Closest Location

Baylor University Medical Center - Dallas, TX

Eligibility Criteria

This trial is for patients born any sex aged 18 and older. You must have received newly diagnosed for Glioblastoma. There are 10 eligibility criteria to participate in this trial as listed below.

Mark “yes” if the following statements are true for you:
MRI findings consistent with a suspected GBM or a histologically confirmed newly diagnosed GBM that has not been treated and would benefit from further surgical resection. As vaccine needs to be generated from the patient s tumor, patients will need to be identified prior to definitive surgery.
Preliminary assessment by the neurosurgeons that >80% of the tumor can be resected with an expectation that >7gm of tissue would be resected
Age greater than or equal to 18 years on day of signing informed consent.
Karnofsky performance status greater than or equal to 70%.
Tumor must be supratentorial only.
Stereotactic biopsy will not be allowed unless there is plans for second surgery to remove greater than or equal to 80 % of the tumor.
No prior treatment with radiation or chemotherapy for their GBM.
No prior treatment with carmustine wafers.
Pathology must be a GBM, MGMT promoter region determined to be unmethylated and IDH wild type greater than or equal to 80 % resection of contrast enhanced tumor on post operative MRI and greater than 7 grams of tumor resected are required otherwise patient is ineligible.
Treatment must be initiated greater than or equal to 14 days and < 6 weeks from surgery.

Patient Q&A Section

What are the signs of glioblastoma?

"The most important sign of glioblastoma is the appearance of symptoms. The main symptoms and diagnostic criteria are headache, lethargy, focal neurological deficits and deterioration. In the case of the last symptom, the patients are urgently investigated and the standard diagnostic tests are performed, particularly for patients who do not have a head trauma problem. Because a recent (December 2017) article (1, 2, 3) states that the symptoms of glioblastoma may appear years before this disease can be diagnosed, a detailed medical interview, including the history of any head trauma (brain trauma), should first be performed in patients with these symptoms." - Anonymous Online Contributor

Unverified Answer

Can glioblastoma be cured?

"Current research suggests there is a relationship between schizophrenia and glioblastoma. We need to find which factors might contribute to the increased risk of glioblastoma in patients diagnosed with schizophrenia. If we manage schizophrenia appropriately, the prognostic impact of schizophrenia on glioblastoma may no longer be present. There is also some hope that anti-inflammatory and immunosuppressive therapies may be used to combat brain tumors. The prognosis for many types of brain tumor, including glioblastoma, is poor; it has a median survival of only 3.5 to 4.3 years. Achieving a cure, while difficult, is still possible." - Anonymous Online Contributor

Unverified Answer

How many people get glioblastoma a year in the United States?

"The U.S. rate of incidence of anaplastic astrocytoma was 7.24 per 100,000 per year, and the rate of glioblastoma was 2.35 per 100,000 per year. The incidence of anaplastic astrocytoma increased significantly in males (3.27 per 100,000) and people 65 years old and older (9.51 per 100,000). The number of new cases per year of glioblastoma has decreased significantly for both males (2.13 per 100,000) and females (1.95 per 100,000) but only in ages 65 years old and older (0.47 per 100,000)." - Anonymous Online Contributor

Unverified Answer

What causes glioblastoma?

"Glioblastoma is most frequently caused by a combination of genetic mutations and environmental exposures. Exposure to ionizing radiation and cigarette smoking increase the risk for developing the disease." - Anonymous Online Contributor

Unverified Answer

What are common treatments for glioblastoma?

"Complete surgical resection of tumor is the most effective treatment for patients with glioblastoma. Surgery combined with radiation and chemotherapy improves survival rates, but treatment with only surgery does not improve survival compared with surgery without radiation or chemotherapy. Chemotherapy is usually needed to improve survival; however, the addition of radiation does not improve survival even if it is combined with chemotherapy. A randomized study will be conducted with longer follow-up time to evaluate whether and when to stop chemotherapy and whether the survival benefit is maintained when chemotherapy is discontinued." - Anonymous Online Contributor

Unverified Answer

What is glioblastoma?

"Glioblastoma is a type of brain tumour that arises from glial cells that line the brain and spinal cord. Most glioblastomas form slowly over several years. It can be distinguished from other brain tumours by features such as consistency, shape, the presence of cysts, loss of the corpus callosum and the cerebrospinal fluid level. Most patients have symptoms such as headache, nausea, loss of appetite and changes in bowel or bladder habits. Glioblastoma is thought to arise from a simple combination of genetic and environmental factors, particularly DNA damage and loss of tumour suppressor genes. Diagnostic imaging techniques include computed tomography scans and magnetic resonance imaging scans." - Anonymous Online Contributor

Unverified Answer

Who should consider clinical trials for glioblastoma?

"As more treatments are tested in clinical trials, there is an increasing need for clinical trial criteria for glioblastoma which will need to reflect the heterogeneity within the disease. The need for clinical trial participation, as we await the next generation of therapies is crucial." - Anonymous Online Contributor

Unverified Answer

What is the average age someone gets glioblastoma?

"The age at diagnosis of glioblastoma was 55.10 yr, with a range of 22.0-71 yr. The incidence rate of glioblastoma in Western countries and the incidence of a malignant glioma in patients younger than 45 yr are 5-10%, and these diseases are often diagnosed in younger patients. The incidence rate in Japan is lower (0.2%), but the peak age is advanced (70 yr). The peak age of individuals diagnosed with glioblastoma in Israel is younger than that in Western countries." - Anonymous Online Contributor

Unverified Answer

What are the chances of developing glioblastoma?

"Results from a recent clinical trial of the study suggest that, in most European and North American population, the risk of developing GBM is not a significant concern." - Anonymous Online Contributor

Unverified Answer

Does pembrolizumab improve quality of life for those with glioblastoma?

"Results from a recent clinical trial suggest that pembrolizumab is well tolerated and may be beneficial for patients with recurrent GBM and for patients in long-term care." - Anonymous Online Contributor

Unverified Answer

Is pembrolizumab typically used in combination with any other treatments?

"In this retrospective meta-analysis, there is no significant difference in outcomes between patients treated with combination of pembrolizumab and other therapies and patients treated with pembrolizumab alone. In this subset of patients, pembrolizumab should be considered the preferred treatment regimen." - Anonymous Online Contributor

Unverified Answer

What is the latest research for glioblastoma?

"The overall number of publications on GBM-related research (as measured by PubMed Central) is in line with all of the recent literature on the subject, suggesting that there has been no significant break in the pace of GLI research since 2006." - Anonymous Online Contributor

Unverified Answer
Please Note: These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
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