Phase 2 Endometrial 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:

• People aged 18 or older.
• People whose general health and ability to carry out daily activities meets a certain standard (rated 0–2 on a medical scale called ECOG), with a life expectancy of at least 6 months.
• People who have been newly diagnosed with advanced (stage III or IV) endometrial cancer, or whose endometrial cancer has come back after receiving no more than one course of platinum-based chemotherapy (including chemotherapy given before surgery, after surgery, or alongside radiation). For people whose cancer stopped responding to platinum-based chemotherapy, at least 12 months must have passed since that treatment ended.
• People whose tumour has an abnormal p53 protein (shown by a laboratory test on tumour tissue) and a confirmed TP53 gene mutation (found by genetic testing).
• People who have not previously been treated with immune checkpoint inhibitors or PARP inhibitor drugs.
• People who have stopped any previous radiation therapy, chemotherapy, or hormone therapy at least 4 weeks before joining the trial.
• People whose liver, kidney, and blood cell levels fall within ranges considered acceptable for this trial (confirm specific values with the trial site).
• People whose thyroid hormone levels are within an acceptable range before joining (confirm with trial site).
• People with little or no nerve damage in their hands or feet (below a certain severity level).
• People who are willing and able to provide a tumour tissue sample from their diagnosis or recurrence for a specific genetic test (HRD testing).
• People who are willing to attend clinic visits and follow-up appointments as required by the trial.

Who may not be able to join:

• People who are currently in another clinical trial, or who have completed another clinical trial within the past 4 weeks.
• People with a known allergy to any ingredient in the trial drug.
• People who have previously been treated with immune checkpoint inhibitor drugs (such as anti-PD-1 or anti-PD-L1 medicines).
• People who need to take immune-suppressing medications.
• People who have previously been treated with PARP inhibitor drugs.
• People who need to take corticosteroids (such as prednisone) at doses higher than 10 mg per day, or who have done so in the two weeks before starting the trial drug.
• People with an active autoimmune disease, or a history of certain autoimmune conditions such as active hepatitis, lung inflammation, eye inflammation, inflammatory bowel disease, or thyroid disorders, among others. Some exceptions may apply (confirm with trial site).
• People who are currently being treated with antibiotics, antiviral, or antifungal medicines for an active infection.
• People with a history of immune system deficiency, including HIV.
• People with significant heart problems within the past year, including certain types of heart failure, unstable chest pain, a heart attack in the past year, atrial fibrillation, or certain abnormal heart rhythms, or specific abnormalities on a heart tracing (ECG).
• People who have had a blood clot in an artery or vein within the past 6 months.
• People with high blood pressure that is not well controlled with medication, or with significant levels of protein in their urine.
• People with blood clotting problems, a tendency to bleed, or who are receiving blood-thinning or clot-dissolving treatment.
• People who have had another cancer within the past 5 years, with the exception of certain types of skin cancer (basal cell or squamous cell carcinoma of the skin).
• People who have received a live vaccine within 4 weeks before starting the trial drug. (Standard inactivated flu vaccines are generally allowed — confirm with trial site.)
• People with a history of substance abuse involving psychotropic drugs that has not been resolved, or people with a psychiatric disorder.
• People whom the trial doctors believe may have any other medical, psychological, or social reason that could affect their safety, their ability to consent, or their ability to complete the trial.

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