Phase 1 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 a specific type of endometrial cancer (called pMMR) that has either come back after surgery alone, or that cannot be surgically removed, and where external beam radiation therapy has been identified as an appropriate treatment approach — with confirmed cancer type from a tissue sample or biopsy (a fresh biopsy is required if the cancer returned more than 6 months ago)
• People whose cancer can be measured on scans, with at least one area of disease at least 1.0 cm in size located in the pelvis and/or vagina, and no cancer spread outside the pelvic area
• People who are well enough to carry out basic daily activities (a standard measure of physical functioning called ECOG 0–2, or a Karnofsky score of 50 or above)
• People whose cancer has been confirmed as the pMMR subtype (a specific cancer characteristic determined through testing)
• People whose blood test results show that their bone marrow, kidneys, and liver are functioning within the levels required by the trial (confirm specific values with trial site)
• Women of childbearing potential who are willing to use two methods of birth control at the same time, or who are surgically sterile, or who abstain from heterosexual activity, during the study and for at least 120 days after the last dose
• People who are able to understand the study and are willing to sign a written consent form
• Women aged 18 years or older

Who may not be able to join:

• People who have taken part in another clinical trial or used an investigational device within 4 weeks before the first dose
• People whose cancer is the dMMR subtype of endometrial carcinoma or uterine carcinosarcoma
• People with active cancer that has spread to the brain or the membranes surrounding the brain — though people with previously treated and stable brain metastases may be considered, provided they meet specific conditions (confirm with trial site)
• People with another active cancer that is growing or currently being treated — though some skin cancers and cervical cancer in situ that have been treated may be exceptions (confirm with trial site)
• People who have previously been treated with lenvatinib, or certain immunotherapy drugs that target specific immune system pathways (such as PD-1 or PD-L1 inhibitors)
• People whose treating doctor has planned for them to receive vaginal brachytherapy (a type of internal radiation) as their pelvic boost treatment
• People who have previously had radiation therapy to the vagina, pelvis, or abdomen
• People with serious uncontrolled medical conditions — such as severe heart failure, unstable chest pain, heart rhythm problems, or other significant medical or personal circumstances that the trial team determines could interfere with participation
• People who have received steroid therapy or other immune-suppressing medications within 21 days before the first dose (some exceptions may apply — confirm with trial site)
• People with interstitial lung disease or active non-infectious lung inflammation
• People with uncontrolled high blood pressure as recorded in their medical history
• People with a psychiatric condition or substance use disorder that the trial team determines could interfere with participation
• People who are pregnant, breastfeeding, or planning to become pregnant during the study or within 120 days after the last dose
• People with uncontrolled HIV infection, defined as being on antiviral treatment for less than 4 weeks and having a high level of HIV in the blood
• People with uncontrolled or chronic hepatitis B infection, depending on specific blood test results (confirm details with trial site)
• People with active, untreated hepatitis C, or who have not completed their hepatitis C treatment — though people with a past hepatitis C infection and undetectable virus levels may be considered
• People who have received a live vaccine within 30 days before the first dose
• People with active tuberculosis (TB)
• People with a specific type of heart electrical abnormality detected on an ECG (a QTcB measurement of 480 milliseconds or above)
• People who are currently receiving other biological therapies at the same time
• People who do not have the capacity to make their own decisions about participation
• People who have not yet recovered from a major surgical procedure

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