Phase 1 Brain Cancer Trial, Recruiting

Written by an AI model from ClinicalTrials.gov eligibility criteria and checked on a sample basis. Please confirm against the original criteria.

Who might be able to join this trial:

• Adults aged 18 or older who have been newly diagnosed with a specific type of aggressive brain tumour (Grade IV Glioblastoma or gliosarcoma), confirmed by laboratory testing, who had carmustine wafers placed in the brain during surgery
• People who have had no prior treatment for their brain tumour other than surgical removal and placement of carmustine wafers (having had a biopsy before the main surgery is allowed)
• People who had a brain scan (MRI or CT) within 72 hours after their surgery
• People who have substantially recovered from their surgery
• People who are on a stable or reducing dose of steroid medication
• People with a Karnofsky Performance Status score of 60 or above — a medical measure of physical ability and general health (confirm with trial site)
• People whose doctors consider them medically suitable to receive a combination of chemotherapy (temozolomide) and radiation therapy at the same time
• People whose blood tests show their organs and bone marrow are functioning within normal ranges
• People who are willing and able to sign a consent form, attend scheduled visits, and follow all study requirements
• Women who are not pregnant or breastfeeding, and who meet the contraception requirements set out by the trial
• Men who agree to take reliable precautions to avoid fathering children from the start of screening until 180 days after the last dose of the study drug

Who may not be able to join:

• People whose glioblastoma has come back after previous treatment, or whose tumour was previously a lower-grade tumour that has progressed
• People who have a significant bleed in the brain (above a minor level) shown on their baseline MRI scan, unless it has since resolved
• People who have cancer that has spread outside the brain or into the lining of the brain or spinal cord
• People who plan to use other cancer treatments during the trial, including the Optune® device
• People with serious or uncontrolled medical conditions that, in the investigator's view, could increase the risks of taking part or affect how the study results are interpreted
• People who have previously been treated with certain types of immune system-targeting drugs, including anti-PD-1, anti-PD-L1, anti-PD-L2, anti-CD137, or anti-CTLA-4 therapies, or similar checkpoint or T-cell targeting treatments
• People with an active autoimmune disease (a condition where the immune system attacks the body), with some exceptions — certain manageable conditions such as type 1 diabetes, thyroid conditions managed with hormone replacement, or mild skin conditions not needing systemic treatment may still be eligible (confirm with trial site)
• People who have had a life-threatening reaction to a previous immunoglobulin treatment or to any component of the study drugs, unless the treating doctor has confirmed in writing that it is unlikely to happen again
• People with other brain or nervous system conditions unrelated to their cancer (such as uncontrolled seizures or abscess) that are not adequately managed
• People who have had a surgical procedure within 7 days before starting study treatment (placement of a central venous access device is an exception)
• People who are unable to swallow tablets, or who have a digestive system condition or prior surgery that could seriously affect how the body absorbs the chemotherapy drug temozolomide
• People with another active cancer diagnosed within the past 3 years, with some exceptions for certain slow-growing or fully treated cancers such as specific skin cancers, early-stage melanoma, low-to-intermediate grade localised prostate cancer, or fully treated early-stage cervical, breast, or bladder cancer (confirm with trial site)
• People with a known history of hepatitis B or hepatitis C infection, or detectable levels of either virus
• People with a known history of HIV or AIDS
• People with a history of, or current, lung inflammation not caused by infection (interstitial lung disease or pneumonitis)
• People who have received certain types of radiation therapy in the chest area within 6 months before starting the trial, or any palliative radiation therapy within 1 week before starting
• People who still have side effects from previous treatments that have not returned to a mild or baseline level (except for hair loss, or mild anaemia not requiring transfusions)
• People whose blood test results at the start of the trial fall outside specified acceptable ranges (confirm with trial site)
• People with an active autoimmune disease that requires high-dose steroid medication or other immune-suppressing drugs (above a low maintenance level), with some exceptions for low-dose steroids, inhalers, or topical treatments
• People with an active infection currently being treated with antibiotics or antifungal medication
• People who have had an organ transplant or stem cell transplant from a donor
• People with a known allergy or sensitivity to retifanlimab or any of its ingredients
• People who have received a live vaccine within 28 days before starting the study drug — examples include measles, mumps, rubella, chickenpox, yellow fever, and certain typhoid and flu vaccines (inactivated flu vaccines and approved COVID-19 vaccines are generally permitted — confirm with trial site)
• People who are currently taking probiotic dietary supplements
• People with uncontrolled ongoing illness
• People with psychiatric illness or social circumstances that would make it difficult to follow the study requirements, including people who are prisoners or involuntarily confined

Important: Always verify eligibility with the trial site directly before applying.