Study on Pembrolizumab for Treating Recurrent Glioblastoma

Sponsor: M.D. Anderson Cancer Center

Sponsor score: 0

ClinicalTrials ID:NCT02337686

Provider View

This clinical trial is exploring the effects of pembrolizumab, an immunotherapy drug, on patients with glioblastoma that has returned. The study aims to see if pembrolizumab can help the immune system attack the cancer and stop it from growing.

Patient Parameters

Program Overview

This phase II study is investigating how pembrolizumab, a type of immunotherapy, affects patients with glioblastoma that has come back after treatment. Pembrolizumab is a monoclonal antibody that may help the immune system target and destroy cancer cells, potentially preventing the tumor from growing and spreading.

Description

The main goals of this study are to:

  • Examine how pembrolizumab affects immune cells in glioblastoma tissue after surgery in patients whose cancer has returned.
  • See if there is a link between the time patients live without the cancer getting worse and changes in immune cells in the tumor.

Other goals include:

  • Comparing how long it takes for the cancer to progress after pembrolizumab treatment versus after the last treatment.
  • Measuring the overall response and survival rates, and checking for any side effects.
  • Identifying any changes in imaging scans that relate to immune changes in the tumor after treatment.

Study Process:

  • Patients will receive pembrolizumab through an IV drip on two separate days before surgery.
  • Surgery will take place on the third day.
  • After recovering from surgery, patients will continue to receive pembrolizumab every three weeks for up to two years, as long as the cancer does not progress and side effects are manageable.
  • After finishing the treatment, patients will have follow-up visits every three months.

Eligibility Criteria

Inclusion Criteria

  • Must be willing to provide written consent to participate.
  • Have a confirmed diagnosis of grade IV glioblastoma or gliosarcoma.
  • Be at the first or second recurrence of the tumor and need surgery for tumor growth.
  • Have a tumor that can be measured and is at least 1 cm³ in size.
  • Provide a tissue sample from a previous biopsy or a new biopsy.
  • Have a performance status score of 60 or higher on the Karnofsky scale, indicating the ability to care for oneself.
  • Be on a stable dose of steroids for at least five days, with no more than 2 mg of dexamethasone per day.
  • Meet specific blood count and organ function criteria.
  • Women of childbearing potential must have a negative pregnancy test and agree to use two forms of birth control during the study and for 120 days after the last dose.
  • Men must agree to use contraception during the study and for 120 days after the last dose.

Exclusion Criteria

  • Have previously been treated with bevacizumab.
  • Have a tumor located mainly in the brainstem or spinal cord.
  • Have received certain types of local treatments for the tumor.
  • Are participating in another clinical trial or have used an investigational drug within the last four weeks.
  • Have an immune deficiency or are on high-dose steroid therapy.
  • Have had a monoclonal antibody treatment within the last four weeks.
  • Have had chemotherapy or radiation therapy within the last two weeks.
  • Have another active cancer that requires treatment.
  • Have active autoimmune diseases or require systemic treatment for autoimmune conditions.
  • Have lung disease or active infections.
  • Have any condition that might interfere with the study results or participation.
  • Are pregnant or breastfeeding, or planning to conceive during the study period.
  • Have a history of HIV, hepatitis B, or hepatitis C.
  • Have received a live vaccine within 30 days before starting the study treatment.

Locations

FACILITYZIPCITYSTATE
M D Anderson Cancer Center77030HoustonTexas

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