Phase 3 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 to 45 years old
• People who strongly wish to preserve their fertility (ability to have children) or to keep their uterus, even if they do not plan to have children
• People newly diagnosed with endometrial cancer (cancer of the lining of the uterus), confirmed through a tissue sample taken by biopsy, a uterine scraping procedure, or a camera examination of the uterus
• People who were previously treated for endometrial cancer without surgery to remove the uterus, whose cancer has come back more than 6 months after their last treatment (or where the trial site has assessed them as suitable to join)
• People who have had imaging scans (such as MRI or CT scans) within 2 weeks before starting treatment, confirming the cancer has not spread outside the uterus; people with an allergy to iodine contrast dye may have MRI used instead of CT
• People whose cancer has been tested and found to belong to one of these specific molecular types: POLE-mutant, NSMP (no specific molecular profile), or MSI-H (a type with high microsatellite instability)
• People who are willing and able to give written informed consent to take part
• People who are able to attend scheduled follow-up visits at the treating hospital and are willing to cooperate with the study requirements
• People whose major organ function blood test results fall within the ranges required by the trial (covering white blood cell counts, platelet counts, liver enzyme levels, and kidney function markers — confirm specific values with the trial site)
• People with a good general health and physical function score, as assessed by standard medical rating tools (KPS score of 90 or above, and ECOG score of 0 to 2)
• People currently taking thyroid medication, calcium tablets, vitamin D, bone-strengthening medications, metformin, aspirin, or similar medicines
• People whose case has been reviewed by a multidisciplinary medical team before treatment begins
• People whose cancer meets additional criteria based on their specific molecular subtype:
  • POLE-mutant type: cancer assessed as early stage (FIGO 2023 Stage IA) with no spread outside the uterus
  • MSI-H/dMMR type: cancer assessed as early stage (FIGO 2023 Stage I or II); people with Lynch syndrome (an inherited condition) who also have other Lynch-related cancers in other parts of the body may still be considered
  • NSMP type: cancer assessed as very early stage (FIGO 2023 Stage IA1), a specific cell type called endometrioid carcinoma, low-to-moderate tumour grade (G1 or G2), cancer confined to the inner lining of the uterus only, and specific protein test results showing ER-positive and L1CAM-negative (confirm with trial site)

Who may not be able to join:

• People whose cancer molecular subtype is unclear, or who decline molecular subtype testing
• People whose cancer belongs to the p53-abnormal molecular subtype
• People whose tissue test results show the cancer is ER-negative (a specific protein marker is absent)
• People whose tissue test results show the cancer is L1CAM-positive (a specific protein marker is present in 10% or more of cells)
• People who, in the 6 months before joining, received any of the following treatments continuously for 3 months or more: high-dose progestins (such as megestrol acetate or medroxyprogesterone acetate), hormone injections called GnRHa with or without letrozole, immune checkpoint inhibitor medicines, a hormonal intrauterine device (such as Mirena), or other treatments that could affect how the trial results are measured
• People who have medical reasons preventing them from safely taking the trial medications (immune checkpoint inhibitors, progestins, GnRHa, or letrozole)
• People with serious medical conditions or severe liver disease
• People who have had a major organ transplant in the past
• People with a history of severe mental illness or significant brain function disorders
• People with a history of autoimmune disease that has required immune-suppressing medication
• People with a history of substance misuse or drug addiction
• People who want a hysterectomy (surgical removal of the uterus) or any treatment other than conservative drug-based treatment
• People who are unlikely to be able to follow the study plan as required
• People with POLE-mutant or NSMP cancer who also have another gynaecological cancer; people with a non-gynaecological cancer may also be excluded if the trial site's multidisciplinary team determines it would affect the fertility-preserving treatment or the study results
• People with MSI-H/dMMR cancer (without Lynch syndrome) who also have another cancer, where the trial site's multidisciplinary team determines it would affect treatment choices or the ability to assess results

Additional reasons a person may not be eligible if immune checkpoint inhibitor treatment is involved:

• People who have previously been treated with certain immune-based cancer medicines targeting PD-1, PD-L1, PD-L2, CTLA-4, or similar pathways
• People who have received, or are planned to receive, a live vaccine within 30 days before starting the trial treatment (inactivated vaccines are permitted)
• People with a known intolerance to the trial medicines or their ingredients
• People diagnosed with an immune deficiency condition, or who have been taking steroid medicines at 10mg or more of prednisone per day (or an equivalent dose) or other immune-suppressing medicines within 7 days before starting treatment
• People who have had a severe allergic reaction (Grade 3 or higher) to PD-1 or PD-L1 type medicines or their ingredients
• People who have had an active autoimmune disease requiring systemic medical treatment within the past 2 years (note: standard hormone replacement therapies such as thyroid or insulin treatment are not considered systemic treatment and are permitted)
• People with a history of lung inflammation (pneumonitis) that required steroid treatment, or who currently have pneumonitis
• People with an active infection currently requiring systemic treatment
• People with a known HIV infection
• People with known active hepatitis B (HBsAg-positive) or active hepatitis C (detectable HCV RNA); some people with well-controlled or low-level hepatitis B may be considered after careful evaluation by the trial site (confirm with trial site)
• People with any medical history, current condition, treatment, or test result that the trial site determines could interfere with the study or make participation not in the person's best interest
• People with a known mental illness or substance misuse disorder that could affect their ability to follow the study requirements
• People who have had a tissue or solid organ transplant from another person
• People who have not fully recovered from surgery or who have ongoing complications from a recent surgical procedure
• People who are currently breastfeeding

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