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:

• Women aged 18 to 70 years who are willing to sign a consent form to take part
• People with cervical cancer that has come back, never fully went away, or has spread to other parts of the body (classified as FIGO Stage IVB), confirmed by a tissue test (pathology report required), including the cancer types squamous cell carcinoma, adenocarcinoma, adenosquamous cell carcinoma, or clear-cell carcinoma — where surgery or radiation treatment is no longer a curative option, and no prior whole-body cancer treatment has been given for this stage of the disease
• People whose tumor tissue tests positive for a protein called PD-L1 (with a score of 1 or higher, measured by a central laboratory) — tissue samples from surgery or biopsy must be provided (fine needle samples or liquid-based cell samples are not accepted; bone metastasis samples that have been through a decalcification process are not accepted)
• People who have at least one measurable tumor that can be tracked on scans, according to standard measurement guidelines (RECIST v1.1)
• People expected to live for at least 12 weeks, as assessed by the treating doctor
• People who are generally well enough to carry out daily activities with no or only minimal limitations (rated 0 or 1 on a standard health scale called ECOG)
• Women who could become pregnant must have a negative blood pregnancy test within 7 days before starting the trial, and must agree to use effective contraception throughout the trial and for 6 months after the last dose; women who have not had a period for at least 12 months are considered post-menopausal
• People who are able to understand what the trial involves and are willing and able to follow all trial and follow-up steps

Who may not be able to join:

• People whose cervical cancer is of a different tissue type, such as small cell carcinoma or sarcoma
• People who are pregnant or breastfeeding
• People who received radiation therapy within 14 days before starting the trial (with a limited exception for small areas of palliative radiation to bone for pain relief); people who received chemotherapy to boost the effects of radiation within 14 days before starting; people who used certain traditional Chinese medicines or herbal treatments with anti-tumor purposes within 14 days before starting
• People who received a live, weakened (attenuated), or mRNA vaccine within 4 weeks before screening, or who plan to receive one during the trial
• People who have previously received any treatment that works by targeting the immune system's cancer-fighting checkpoints — such as anti-PD-1, anti-PD-L1, or anti-CTLA-4 drugs, or similar immune-boosting therapies
• People who still have side effects from previous cancer treatments that are rated above a mild level (above Grade 1) at the time of starting the trial — with some exceptions such as ongoing hair loss, fatigue that has stabilised, moderate nerve-related side effects, or a thyroid condition managed with hormone replacement; also people who previously had severe immune-related side effects (Grade 3 or higher) or who had to stop immunotherapy because of immune-related side effects at any level
• People with active cancer spread to the membranes around the brain, or with brain metastases that are not stable — people with stable, symptom-free brain metastases confirmed on imaging at least 28 days before starting may be considered (confirm with trial site)
• People who had major surgery (not including biopsy) or a serious injury within 4 weeks before starting, or who plan to have elective surgery during the trial
• People who had a serious infection requiring hospitalisation within 4 weeks before starting, or who have an active infection at the time of starting
• People with HIV infection; active hepatitis B infection (with specific blood test levels above set thresholds); active hepatitis C infection; or certain positive test results for syphilis
• People with tuberculosis that has not been treated or is currently being treated — people whose tuberculosis was fully treated and cured may be considered (confirm with trial site)
• People with a known history of severe allergic reactions (Grade 3 or higher) to large-protein medicines or monoclonal antibody drugs, or to any ingredient in the study drug
• People with a known allergy or other medical reason preventing the use of cisplatin, carboplatin, or paclitaxel (chemotherapy drugs used in this trial)
• People with a significant blockage of the kidneys' drainage system that cannot be relieved by a medical procedure, as judged by the treating doctor
• People with uncontrolled fluid build-up around the lungs, heart, or abdomen that requires repeated draining
• People with an active autoimmune disease, or one that may come back — exceptions may include vitiligo, autoimmune thyroid conditions managed with hormone replacement, or type 1 diabetes
• People who needed regular steroid treatment (above 10 mg per day of prednisone or equivalent) or other immune-suppressing medicines within 14 days before starting — with exceptions for topical, inhaled, eye, nasal, or joint steroid use, or a short course taken to prevent an allergic reaction to a medical procedure
• People who needed steroid treatment for a non-infectious lung condition in the past year, or who currently have a chronic lung scarring condition (interstitial lung disease)
• People with a significant history of heart or blood vessel problems, including: moderate-to-severe heart failure or reduced heart pump function; serious heart rhythm problems; a heart attack, stroke, heart failure, aortic tear, or other major cardiovascular event within the past 6 months; or blood pressure that remains very high (above 160/100 mmHg) despite medication

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