NCT04969887

Who might be able to join this trial:

• You are willing and able to attend scheduled visits, follow the treatment plan, and complete required tests throughout the study.
• You have been diagnosed with one of the following cancer types (confirmed by a tissue sample): certain neuroendocrine cancers (atypical bronchial carcinoid, neuroendocrine carcinoma, or Grade 3 neuroendocrine tumours, but not small cell lung cancer); bile duct or gallbladder cancers; certain gynaecological cancers (ovarian or uterine clear cell carcinoma, uterine or ovarian carcinosarcoma, uterine leiomyosarcoma, or vaginal/vulval squamous cell carcinoma); or cancers with a specific DNA repair defect called "MSI-H" (but not colorectal cancer).
• You are generally well enough to carry out light activity and care for yourself (this is measured by a standard doctor's rating scale called ECOG, with a score of 0 or 1).
• You have had no more than one previous systemic (whole-body) cancer treatment for advanced disease, and it was finished at least 4 weeks before joining — or you are not suitable for, or have chosen not to have, standard treatments. (For MSI-H cancers and atypical bronchial carcinoid, any number of previous treatments is allowed, as long as the last one finished at least 4 weeks ago.)
• Any previous radiotherapy was completed at least 2 weeks before starting the study treatment.
• Your cancer can be measured on a CT or MRI scan using standard medical criteria.
• A tissue sample from your cancer (from a site that cannot be surgically removed, or that has spread) is available for testing.
• Your recent blood test results (taken within 14 days before joining) meet certain minimum levels for white blood cells, neutrophils, platelets, haemoglobin, kidney function, liver enzymes, and bilirubin (confirm specific numbers with the trial site).
• You are 18 years of age or older.
• If you are a woman who could become pregnant, you agree to use effective contraception for at least 23 weeks after your last dose of study drug.
• If you are a woman who could become pregnant, you have a negative pregnancy test within 24 hours before starting the study treatment.
• If you are a man who could father a child, you agree to use highly effective contraception for at least 31 weeks after your last dose of study drug.

Who may not be able to join:

• You have active cancer that has spread to the brain or the lining of the brain — though you may still be eligible if brain metastases were previously treated, showed no signs of growth for at least 8 weeks, and you have not needed high-dose steroid medicines for at least 2 weeks (confirm with trial site).
• You have previously had a combination of two types of immunotherapy drugs targeting both the PD-1/PD-L1 pathway and the CTLA-4 pathway at the same time. (Having had just one of these types on its own is allowed.)
• You have a serious or uncontrolled medical condition that, in your doctor's opinion, could make it unsafe for you to take part or affect the study results.
• You have had another active cancer within the past 3 years, unless it was a type that is considered easily cured (such as certain skin cancers, early bladder cancer, or carcinoma in situ of the prostate, cervix, or breast).
• You have an active autoimmune disease — though some milder conditions (such as vitiligo, well-controlled type 1 diabetes, thyroid conditions managed with hormone replacement, or mild psoriasis not needing systemic treatment) may still be acceptable (confirm with trial site).
• You are currently taking high-dose steroid medicines or other immune-suppressing medicines (above a certain level) and have been doing so within the 14 days before starting the study.
• You have a current active hepatitis B or hepatitis C infection shown by a blood test.
• You have a known history of HIV or AIDS.
• You have a known allergy to any of the study drugs or their ingredients.
• You have had a severe allergic reaction to any monoclonal antibody medicine in the past.
• You are pregnant, breastfeeding, or have a positive