Study Goal

The goal of this study is to compare the effectiveness of adding an immunotherapy drug (retifanlimab) to the standard of care (radiation and chemotherapy) for people with glioblastoma (GBM) brain tumor who had a GBM removal surgery with placement of Gliadel wafers.

Study Overview

• Study Title: 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
• Study ID: J21103 / IRB00291102 / NCT05083754
• Principal investigators: Lawrence Kleinberg, D., Matthias Holdhoff, M.D.
• Eligibility criteria: People with suspected GBM who are being considered for surgery with placement of Gliadel Eligible candidates must discuss this study with the research team and/or their surgeon and sign the pre-surgery screening consent form before the GBM surgery.
• Total participants: 50
• How to participate: please contact Kelly Szajna (kszajna1@jhmi.edu)
• Study sites:
  • The Johns Hopkins Hospital
  • Sibley Memorial Hospital
  • Vanderbilt University Medical Center
  • Providence Health
• Learn more on clinicaltrials.gov

Who Can Participate

A participant must meet all four initial criteria:

• Be 18 years of age or older
• Be referred for surgery for suspected newly diagnosed GBM
• Be considered for surgery with placement of Gliadel
• Participants who have the surgery at Johns Hopkins must sign the pre-surgery screening consent form that expresses their interest in the study before the surgery.

What to Expect

Screening and Consent

• If your surgery is at Johns Hopkins, your surgeon will discuss the study with you. You can enroll in this study only if you had a discussion with our study team and your doctors before your brain tumor surgery. You will also be asked to sign the pre-surgery screening consent form. This form expresses your interest in participating in the study. You will not be able to opt into the study after the However, you will be able to opt out of the study, even if you already signed the consent.

• If you plan to have or already had the surgery at another hospital, please coordinate your participation with our study team. Signing a pre-surgery consent is not required.

Brain Tumor Surgery

During your brain tumor removal surgery, your surgeon will decide if you would benefit from the placement of Gliadel wafers as part of the standard of care. Gliadel wafers are a standard treatment (not research) placed during surgery and release chemotherapy into the area of the tumor. The wafers are not the subject of this study, but may be used by your surgeon regardless of your interest in participation.

If the surgeon determines that your type of GBM will not benefit from the placement of Gliadel wafers, you become ineligible for this study.

If you receive the Gliadel wafers treatment, you may still choose to not enroll in the study.

Whether you receive the wafers or not, the study team and your doctors will discuss your treatment options with you, as well as all research options you may be eligible for.

Tumor tissue removed during surgery will be tested for MGMT (O6- Methylguanin-DNS-Methyltransferase) status, a biomarker that helps the care team understand how the tumor may respond to standard-of-care therapy. This test is done for all patients who have this surgery, regardless of participation in the study.

What to Expect If You Are Selected

You will be randomly assigned (like drawing a number from a hat) to either:

• The Investigational Group to receive retifanlimab and radiation (with or without temozolomide, a chemotherapy drug, based on the results of MGMT biomarker testing), OR
• The Standard of Care (SOC) Group to receive radiation and temozolomide, without

Investigational Group

Participants in the Investigational Group will receive retifanlimab every 28 days by IV infusion (given through a vein) and standard-of-care radiation. Participants found to have a methylated MGMT status from their surgery will also receive temozolomide.

Standard of Care Group

Participants in the Standard of Care Group will receive standard-of-care radiation plus temozolomide. Radiation is given daily (usually Monday through Friday) along with temozolomide for six weeks.

Temozolomide comes as a capsule and is taken by mouth once a day. After a 28-day break, temozolimide will be taken once a day for five days in a row every 28 days for six cycles.

Benefits and Risks

We cannot guarantee any benefits as a result of taking part in this research study. The study team will discuss the risks associated with taking part in this study.