Phase 2 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.
• People whose ability to carry out daily activities meets a certain minimum level, as measured by a standard medical scale called the Karnofsky Performance Status (confirm with trial site).
• People who have been diagnosed with a specific type of brain tumour called Glioblastoma (IDH-wildtype, WHO Grade 4) located in the upper part of the brain, which has come back after standard treatment — including at least radiation therapy, with or without chemotherapy (temozolomide).
• People whose tumour has returned for the first or second time.
• People who are at least 12 weeks past the end of their initial combined chemotherapy and radiation treatment at the time their tumour is confirmed to have returned — or, if the tumour returned earlier, people whose recurrence has been confirmed by biopsy.
• People whose tumour can be measured or assessed on scans using standard criteria (called RANO criteria).
• People who have had a brain MRI scan within the 14 days before joining the study.
• People whose blood, kidney, liver, and clotting test results fall within the required ranges, based on blood tests taken within 14 days of starting treatment (confirm with trial site for specific values).
• People who are not pregnant — women of childbearing potential must have a negative pregnancy test before starting the trial.
• Women of childbearing potential who are sexually active with an unsterilised male partner must be willing to use a highly effective form of contraception from the start of screening until 120 days after the last dose of the study drug (ivonescimab).
• Men who could father a child and are sexually active with a female partner who could become pregnant must be willing to use effective contraception from the start of screening until 120 days after the last dose of the study drug.
• People who are willing and able to give informed consent before any study procedures begin — those with cognitive difficulties may be enrolled with consent from a legal representative, and non-English speakers may enrol if an interpreter is available for all visits and appointments.

Who may not be able to join:

• People who have had major surgery or serious physical injury within 4 weeks before the first dose, or who have major surgery planned within 4 weeks after starting treatment.
• People who are currently pregnant or breastfeeding.
• People with a history of significant bleeding problems or blood clotting disorders, including serious bleeding in the brain, gastrointestinal (stomach or bowel) bleeding, coughing up blood (half a teaspoon or more), or frequent nosebleeds — note that some minor or incidental findings may still be permitted (confirm with trial site).
• People who need ongoing anticoagulant (blood-thinning) treatment for therapeutic purposes — preventive use for blood clots may be allowed (confirm with trial site).
• People with poorly controlled high blood pressure (systolic at or above 150 mmHg or diastolic at or above 100 mmHg) even after taking blood pressure medication.
• People currently taking more than 2mg per day of dexamethasone (a steroid medication) or an equivalent dose of another steroid.
• People with a history of serious heart conditions, such as unstable chest pain, heart attack, heart failure, aortic aneurysm, or poorly controlled irregular heartbeat.
• People with a history of serious stomach or bowel conditions, including varicose veins in the oesophagus or stomach, severe ulcers, non-healing wounds, bowel fistulas, abdominal abscesses, or acute gastrointestinal bleeding.
• People with a history of blood clots in arteries or serious blood clots in veins, mini-strokes (TIA), stroke, or dangerous spikes in blood pressure causing brain symptoms.
• People who have had a flare-up of chronic obstructive pulmonary disease (COPD) within 4 weeks before joining the trial.
• People with a history of holes or abnormal connections in the bowel, bowel blockages requiring intravenous feeding, or major bowel surgery.
• People who have been diagnosed with or treated for another cancer in the past 3 years — exceptions may apply for certain low-risk skin cancers or cervical pre-cancers (confirm with trial site).
• People who have previously received anti-VEGF therapy (such as bevacizumab) or anti-PD-1/PD-L1 immunotherapy for their brain tumour.
• People who have previously received certain specialised local brain treatments, including implanted radiation, heat therapy, chemotherapy wafers (such as Gliadel®), or treatments delivered directly into the brain — or who are currently using Tumour Treating Fields devices.
• People whose tumour has spread to the lining of the brain or spinal cord, spread throughout the brain in a diffuse pattern, spread outside the brain, or appears in multiple separate locations in the brain.
• People with seizures that cannot be adequately controlled with medication, or other significant neurological conditions that could affect safety or results, as assessed by the treating doctor.
• People with a history of significant autoimmune diseases such as lupus, rheumatoid arthritis, inflammatory bowel disease, multiple sclerosis, vasculitis, or similar conditions — some exceptions may apply for well-controlled thyroid conditions, Type 1 diabetes, or mild skin conditions (confirm with trial site).
• People who cannot have an MRI scan or receive MRI contrast dye.
• People who have had a stroke or mini-stroke (TIA) within the 6 months before joining the trial.
• People whose screening scans show the tumour is growing into or wrapping around major blood vessels, or show a cavity (hollow space) forming inside the tumour.

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