Phase 2 Stomach 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:

• Women aged 18 or older who have been confirmed by laboratory testing to have a specific type of ovarian, fallopian tube, or peritoneal cancer (not the low-grade or mucinous types)
• Women who are not pregnant, not breastfeeding, and either cannot become pregnant or agree to use contraception during treatment and for at least 120 days after the last dose
• People who give written consent to participate (or whose legal representative does so on their behalf)
• People who have measurable tumours that can be tracked using standard imaging guidelines
• People with a general health and activity level rated at 0 or 1 on a standard medical scale, meaning they are fully active or restricted only in physically demanding activity
• People who received a first round of platinum-based chemotherapy after surgery, with the cancer returning at least 6 months after that treatment ended — and who have had no more than one additional chemotherapy course since then, with each treatment-free gap being longer than 6 months
• People who can provide a stored or newly obtained tumour tissue sample from a site that has not been previously treated with radiation
• People whose blood pressure is adequately controlled, with or without blood pressure medication
• People whose organ function (such as liver, kidneys, and blood counts) meets the required levels based on blood tests

Who may not be able to join:

• Women of childbearing potential who have a positive pregnancy test
• Women who are pregnant, breastfeeding, or planning to become pregnant during the study period or within 120 days after the last dose
• People who have received certain immunotherapy drugs (such as anti-PD-1, anti-PD-L1, anti-PD-L2, or similar immune-targeting treatments) within the last 6 months
• People who have received other systemic cancer treatments — including chemotherapy, antibody therapies, or targeted drugs — within the 4 weeks before the planned first dose (or within 5 half-lives for certain drug types)
• People who have previously been treated with lenvatinib (one of the study drugs)
• People who have had radiotherapy within 2 weeks before starting the study
• People who previously experienced a severe (Grade 3) immune-related side effect or a non-infectious lung inflammation from immunotherapy
• People who have received more than two prior courses of chemotherapy
• People who have had tumour-related bleeding within one month before joining the study
• People who have received a live vaccine within 30 days before the first dose
• People currently in, or recently finished, another investigational drug study within the past 4 weeks
• People with an immune system deficiency, or who are taking high-dose steroid or other immune-suppressing medications within 7 days before the first dose
• People with another active cancer that has been treated or has been progressing within the past 5 years (with some exceptions such as certain skin cancers or cervical changes in situ)
• People with active cancer spread to the brain or the lining of the brain (with some exceptions for previously treated and now stable brain involvement)
• People with a known severe allergic reaction (Grade 3 or higher) to pembrolizumab or its ingredients
• People with an active autoimmune disease that has required systemic medical treatment within the past 2 years
• People with an active infection currently requiring systemic treatment
• People with a known history of HIV
• People with a known history of hepatitis B, or active hepatitis C
• People with any medical condition, past therapy, or abnormal test result that the treating doctor believes could interfere with the study or would not be in the person's best interest
• People with known psychiatric conditions or substance use disorders that would interfere with participation
• People who have had an organ or tissue transplant from another person
• People with uncontrolled blood pressure
• People with significant abnormalities in electrolyte levels (such as sodium or potassium) that have not been corrected
• People with significant heart problems, including moderate-to-severe heart failure, unstable chest pain, a heart attack, or a stroke within the past 6 months, or a heart rhythm problem causing instability that requires treatment
• People with bleeding or clotting disorders, evidence of major blood vessel involvement by the tumour, or who are considered at risk of serious bleeding
• People with high levels of protein in their urine (above a specified threshold on testing)
• People with a prolonged heart electrical interval (QTc greater than 480 ms) on a heart tracing
• People whose heart pumping function is below the normal range as measured by a heart scan or ultrasound
• People with conditions affecting the absorption of oral medication in the gut, including certain bowel conditions or previous bowel surgery
• People with an existing severe (Grade 3 or higher) abnormal connection or opening between organs (fistula)
• People with a known intolerance to any of the study treatments or their ingredients

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