RecruitingPhase 1NCT05083754

Carmustine Wafer in Combination With Retifanlimab and Radiation With/Without Temozolomide in Subjects With Glioblastoma

A Randomized, Open-label Pilot Trial to Evaluate the Safety and Efficacy of Carmustine Wafer in Combination With Retifanlimab and Standard Radiation With or Without Temozolomide in Newly-Diagnosed Adult Subjects With Glioblastoma


Sponsor

Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins

Enrollment

50 participants

Start Date

Aug 31, 2022

Study Type

INTERVENTIONAL

Conditions

Summary

The purpose of the study is to evaluate the safety and survival of carmustine wafers and radiation and retifanlimab with or without temozolomide (TMZ) in newly-diagnosed adult subjects with glioblastoma multiform after carmustine wafer placement.


Eligibility

Min Age: 18 YearsMax Age: 100 Years

Plain Language Summary

Simplified for easier understanding

This study is testing a new immunotherapy drug called retifanlimab combined with the standard radiation and chemotherapy treatment for people who have just been diagnosed with glioblastoma — the most aggressive type of brain tumor — and already had it surgically removed with chemotherapy wafers (called carmustine wafers) placed in the tumor site. **You may be eligible if...** - You have been newly diagnosed with glioblastoma or a related brain tumor (gliosarcoma) - You already had surgery to remove the tumor, with carmustine wafers placed during that surgery - You have not received any other treatment for your brain tumor - You are 18 or older and have recovered sufficiently from surgery - Your general health is good enough to tolerate chemotherapy and radiation - You are willing to use reliable birth control during the study **You may NOT be eligible if...** - Your brain tumor has come back (recurrent) after prior treatment - You have active autoimmune disease - You have previously received immunotherapy (like PD-1 or CTLA-4 blockers) - You have significant bleeding in the brain on your post-op scan - You are pregnant or breastfeeding - You have another active cancer Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

Interested in this trial?

Get notified about updates and connect with the research team.

Interventions

DRUGRetifanlimab

Anti-PD-1 Therapy

DRUGTemozolomide

Anti-PD-1 Therapy

RADIATIONRadiation Therapy

Standard of Care


Locations(1)

Johns Hopkins Medical Institution

Baltimore, Maryland, United States

View Full Details on ClinicalTrials.gov

For the most up-to-date information, visit the official listing.

Visit

NCT05083754


Related Trials