NCT02923934

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
• You have been diagnosed with one of the following cancer types (confirmed by a tissue sample): upper digestive tract cancers (such as bile duct cancer or duodenal cancer), neuroendocrine tumours (including pancreatic, bronchial, or intestinal carcinoid tumours), or certain rare gynaecological cancers (such as vaginal, vulval, ovarian clear cell, low-grade serous ovarian, carcinosarcoma, female genital tract sarcomas, or granulosa cell tumours)
• Your general health and ability to carry out daily activities meets a specific level set by doctors (known as ECOG performance status 1 — confirm with trial site)
• If you have had previous cancer treatment, it finished at least 4 weeks before joining, and any side effects have settled down — or you are not suitable for, or have chosen not to have, standard treatments
• If you have had radiotherapy, it was completed at least 2 weeks before starting the trial drug
• Your cancer can be measured on a CT or MRI scan
• You are able to provide a tumour tissue sample for testing, or are willing to have a new sample taken if needed
• Your recent blood test results (taken within the last 14 days) meet certain minimum levels for white blood cells, neutrophils, platelets, haemoglobin, kidney function, and liver function (confirm exact values with trial site)
• You are aged 18 or over
• 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 the trial drug, and you have a negative pregnancy test within 24 hours before starting 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 the trial drug
• Women who cannot become pregnant (due to menopause or surgery) and men with no sperm do not need to use contraception

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 received a combination of immunotherapy drugs targeting both the PD-1/PD-L1 pathway and CTLA-4 at the same time (having had just one of these types of drugs on its own may still be acceptable — confirm with trial site)
• You have a serious or uncontrolled medical condition that the doctor feels could make participation unsafe or affect the results
• You have had another active cancer within the last 3 years, unless it was a type considered easily curable, such as certain skin cancers, early bladder cancer, or non-invasive cancers of the prostate, cervix, or breast
• You have an active autoimmune disease (some milder conditions such as vitiligo, type 1 diabetes, thyroid conditions managed with hormone replacement, or stable psoriasis not needing systemic treatment may still be allowed — confirm with trial site)
• You are currently taking steroid medicines above a certain dose (more than 10 mg of prednisone daily) or other medicines that suppress your immune system, and have been doing so within the last 14 days (inhaled or skin-applied steroids may be acceptable — confirm with trial site)
• You have a current or past hepatitis B or hepatitis C infection shown by a positive blood test
• You have HIV or AIDS
• You have a known allergy to any of the study drug ingredients
• You have had a severe allergic reaction to any monoclonal antibody treatment in the past
• You are pregnant, breastfeeding, or have a positive pregnancy test at the time of joining
• You are currently in prison or being held in a facility against your will
• You are being required by law to receive treatment for a mental health or infectious illness

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