Efineptakin Alfa and Pembrolizumab for Treating Recurrent Glioblastoma

Sponsor: Mayo Clinic

Sponsor score: 60
Inactive

ClinicalTrials ID:NCT05465954

Provider View

This study is testing the safety and effects of combining two immunotherapy drugs, efineptakin alfa and pembrolizumab, to treat glioblastoma that has returned after previous treatment. The goal is to see if this combination can help the immune system fight the cancer more effectively.

Patient Parameters

Program Overview

This phase II clinical trial is exploring whether the combination of two immunotherapy drugs, efineptakin alfa and pembrolizumab, can safely and effectively treat glioblastoma that has come back after initial treatment. Efineptakin alfa helps the immune system target tumor cells, while pembrolizumab is a monoclonal antibody that may help the body attack cancer cells and prevent them from growing and spreading. The study aims to determine if this combination can kill more tumor cells in patients with recurrent glioblastoma.

Description

The main goal of this study is to see if the combination of pembrolizumab and efineptakin alfa, along with surgery, can improve survival rates in patients with recurrent glioblastoma. Researchers will also look at how long patients live without the cancer getting worse, how the cancer responds to the treatment, and changes in certain immune cells over time.

Before surgery, patients will receive pembrolizumab through an IV and efineptakin alfa as an injection. Surgery will take place one week later. After surgery, patients will continue to receive both drugs every 42 days for up to two years, as long as the cancer does not progress and side effects are manageable.

Patients will have MRI or CT scans and tumor biopsies to monitor the cancer. Blood samples will also be collected to study the immune response. After completing the treatment, patients will have follow-up visits to check on their health and any changes in the cancer.

Eligibility Criteria

Inclusion Criteria

  • Must be 18 years or older.
  • Have a confirmed diagnosis of recurrent glioblastoma, a type of brain cancer.
  • Previously treated with surgery, radiation, and the drug temozolomide.
  • Have a tumor that can be surgically removed or biopsied.
  • Willing to have surgery or a biopsy at Mayo Clinic in Rochester, Minnesota.
  • Be in good overall health with a performance status score of 0 or 1.
  • Meet specific blood test requirements for hemoglobin, neutrophil count, platelet count, kidney and liver function.
  • Not be pregnant and agree to use contraception during and after the study.
  • Willing to provide tissue and blood samples for research purposes.
  • Agree to return for follow-up visits.

Exclusion Criteria

  • Pregnant or nursing individuals, or those not willing to use contraception.
  • Have severe symptoms of increased pressure in the brain that require immediate surgery.
  • Have received certain treatments like bevacizumab or a live vaccine recently.
  • Have not recovered from side effects of previous treatments like surgery or radiation.
  • Have serious health conditions that could interfere with the study.
  • Have a history of HIV, active infections, or other serious illnesses.
  • Currently taking other investigational drugs.
  • Have had another active cancer within the past year.
  • Have a history of heart problems or autoimmune diseases requiring treatment.
  • Have active hepatitis B or C infections, unless under control.
  • Have a history of tuberculosis or lung diseases requiring steroids.
  • Have allergies to pembrolizumab or similar drugs.
  • Have had certain immunotherapy treatments within the past year.

Get This Program In Your Inbox

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