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 who have been diagnosed with metastatic or returning endometrial cancer (including types such as endometrioid, serous, clear cell, dedifferentiated/undifferentiated, mixed epithelial, adenocarcinoma, or carcinosarcoma) or cervical cancer (including squamous cell carcinoma, adenocarcinoma, or adenosquamous cell carcinoma), confirmed by a tissue biopsy, where the cancer has continued to grow or spread after treatment with at least one chemotherapy regimen containing platinum.
• People whose cancer can be measured on scans, according to a standard set of imaging rules called RECIST v1.1.
• People whose general physical functioning falls within a certain range on a standard medical scale (ECOG Performance Status 0 to 2), meaning people who are fully active, or who have some limitations but are up and about for more than half of waking hours (confirm with trial site).
• People who have received at least one prior platinum-based chemotherapy treatment; previous treatment with PD-1 immunotherapy or VEGF-targeted therapy is also permitted.
• People whose blood pressure is adequately controlled at 160/90 mmHg or below, with or without blood pressure medication.
• People whose blood test results meet the required levels, including sufficient white blood cells, platelets, and red blood cells, and adequate kidney, liver, and thyroid function, and normal blood clotting measures (confirm specific values with trial site).
• People aged 18 years or older at the time of signing the consent form.
• People who have had brain metastases that have already been treated, where follow-up scans show no signs of the brain tumours growing — provided there is no evidence of bleeding, no large lesions over 1.5 cm considered at risk of bleeding, and the person is no longer taking steroid medications at the time of joining the trial.
• People who are not pregnant and not breastfeeding; those who could become pregnant must have a negative pregnancy test at the time of screening.
• People who could become pregnant and are sexually active with an unsterilised male partner must agree to use a highly effective form of contraception from the start of screening until 90 days after the last dose of the study drug ivonescimab.
• People for whom a specific type of genetic tumour data (called clinical IMPACT data) is either already available, or for whom enough tissue is available to obtain it.
• People who have had or currently have another type of cancer, where that cancer or its treatment is not expected to interfere with this trial's safety or results.

Who may not be able to join:

• People who have had major surgery or serious physical injury within the 4 weeks before joining, or who have major surgery planned within 4 weeks after the first dose; also people who have had a minor procedure within 3 days before joining (with some exceptions, confirm with trial site).
• People who have not sufficiently recovered from complications or side effects of a major surgery before starting treatment.
• People who have had significant bleeding problems or a history of blood clotting disorders within 4 weeks before joining, including gastrointestinal bleeding, coughing up blood (half a teaspoon or more of fresh blood), nosebleeds, or who have needed to start new blood-thinning medication within 14 days before joining.
• People who have a history of certain serious heart conditions within the past 12 months, such as unstable chest pain, heart attack, heart failure, or serious blood vessel disease requiring hospitalisation, or poorly controlled heart rhythm problems.
• People with a history of varicose veins in the oesophagus or stomach, severe ulcers, wounds that will not heal, abnormal connections between organs (fistulas), abscesses inside the abdomen, or serious gastrointestinal bleeding within the past 6 months.
• People who have had a blood clot in an artery or vein, a mini-stroke, stroke, or a severe high blood pressure crisis within the past 6 months.
• People who have had a sudden worsening of a chronic lung disease (COPD flare-up) within the past 4 weeks.
• People with a history of a hole developing in the gastrointestinal tract, a gastrointestinal blockage requiring nutritional support through a drip, or extensive bowel removal surgery within the past 6 months.
• People whose scans show that the cancer has grown into or is surrounding major blood vessels, or where there is evidence of hollow spaces forming inside a tumour.
• People who have received another experimental cancer treatment within 4 weeks before starting this study.
• People with a specific type of abnormal heart rhythm measurement on an ECG (QTc interval above 480 milliseconds).
• People with an active or acute Hepatitis B infection (people with chronic Hepatitis B may be considered if they are already on appropriate antiviral treatment — confirm with trial site).
• People with an active or acute Hepatitis C infection (people who have previously had Hepatitis C but no longer have detectable virus may still be considered — confirm with trial site).
• People who are known to have had a serious reaction or intolerance to either of the study drugs or their ingredients.
• People who have received an organ or tissue transplant from another person.
• People who have been diagnosed with an immune system deficiency, or who have been taking steroid medications or other immune-suppressing treatments within 7 days before the first dose (very low-dose steroids may be permitted after discussion with the trial doctors — confirm with trial site).
• People who have an active autoimmune disease that has required systemic medical treatment within the past 2 years (standard hormone or replacement therapies are not considered systemic treatment for this purpose).
• People who have a history of lung inflammation (pneumonitis) not caused by infection that required steroid treatment, or who currently have pneumonitis.
• People who previously had a severe (Grade 3 or higher) immune-related side effect from immunotherapy that led to stopping or significantly delaying that treatment.
• People who have received a live-virus vaccine within 30 days before the planned start of treatment.

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