Study on Pembrolizumab and Standard Therapy for Treating Glioblastoma

Sponsor: Mayo Clinic

Sponsor score: 60

ClinicalTrials ID:NCT03197506

Provider View

This clinical trial is exploring how well pembrolizumab, an immunotherapy drug, works alongside standard treatments like chemotherapy and radiation in patients with glioblastoma, a type of brain cancer. The study aims to see if this combination can help the immune system fight the cancer more effectively.

Patient Parameters

Program Overview

This study is testing the effects of pembrolizumab, an immunotherapy drug, when used with standard treatments such as chemotherapy (temozolomide) and radiation therapy in patients with glioblastoma, a type of aggressive brain cancer. Pembrolizumab may help the immune system attack cancer cells, while chemotherapy and radiation work to stop the growth and spread of these cells. The goal is to see if this combination can improve treatment outcomes for patients.

Description

The main goals of this study are to evaluate the safety and effectiveness of pembrolizumab when combined with standard treatments for newly diagnosed glioblastoma. The study will look at how well patients tolerate this combination and whether it can improve survival rates over 18 months. Researchers will also monitor any side effects and how long it takes for the cancer to progress or return.

Participants are divided into two groups:

  • Group 1 (Neoadjuvant): Patients receive pembrolizumab before surgery, followed by surgery, and then a combination of pembrolizumab, temozolomide, and radiation therapy. After radiation, they continue with pembrolizumab and temozolomide for up to five cycles.

  • Group 2 (Adjuvant): Patients receive pembrolizumab, temozolomide, and radiation therapy after surgery, followed by additional cycles of pembrolizumab and temozolomide.

After completing the treatment, patients will have follow-up visits to monitor their health and any signs of cancer returning. The study will also involve collecting tissue and blood samples for further research.

Eligibility Criteria

Inclusion Criteria

  • Must be 18 years or older.
  • Have a confirmed diagnosis of glioblastoma or grade IV astrocytoma.
  • For Group 1: Must have a brain tumor that can be mostly removed by surgery and be willing to have surgery at Mayo Clinic in Rochester, MN.
  • For Group 2: Must have had surgery to remove the brain tumor within the last 6 weeks.
  • Be in good overall health with an ECOG performance status of 0 or 1.
  • Have adequate blood cell counts and organ function as determined by specific tests.
  • Women of childbearing potential must have a negative pregnancy test and agree to use contraception during the study and for 120 days after the last dose.
  • Agree to provide tissue and blood samples for research purposes.
  • Willing to return to the study site for follow-up visits.

Exclusion Criteria

  • Pregnant or nursing women, or those not willing to use contraception.
  • Have severe symptoms of increased brain pressure that require immediate surgery.
  • Have other serious health conditions that could interfere with the study.
  • Have a compromised immune system or are HIV positive and on antiretroviral therapy.
  • Have uncontrolled illnesses like heart failure or active infections.
  • Have another active cancer within the last 5 years, except for certain skin or cervical cancers.
  • Have had a heart attack or severe heart issues within the last 6 months.
  • Have active autoimmune diseases requiring treatment in the last 2 years.
  • Have active hepatitis B or C, or a history of tuberculosis.
  • Have received a live vaccine within 30 days before starting the study.
  • Have a history of lung inflammation requiring steroids.
  • Are allergic to pembrolizumab or similar drugs.
  • Have used certain cancer treatments or devices before.

Locations

FACILITYZIPCITYSTATE
Mayo Clinic Hospital in Arizona85054PhoenixArizona
Mayo Clinic in Arizona85259ScottsdaleArizona
Mayo Clinic in Rochester55905RochesterMinnesota

Get This Program In Your Inbox

Receive detailed information about this treatment opportunity to review with your healthcare provider.