Phase 2 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 over 18 years at the time of joining the study.
• People who are well enough to carry out daily activities with little to no limitation (measured by a standard scale called ECOG, with a score of 0 or 1).
• For Group 1: People with confirmed advanced or returning bowel cancer (CRC) or uterine cancer (endometrial cancer) that cannot be removed by surgery, whose tumour has a specific genetic feature called MSI-H or dMMR — regardless of what treatments they have had before.
• For Group 2: People with confirmed advanced or returning bowel cancer that cannot be removed by surgery, whose tumour has a different genetic feature called MSS or pMMR, and who have already tried at least 2 types of chemotherapy (including fluoropyrimidine, irinotecan, and/or oxaliplatin, with or without bevacizumab), or who could not tolerate those treatments. If the tumour has a feature called EGFR positive/RAS wild type, prior treatment targeting EGFR is also required. Also included in Group 2: people with advanced or returning uterine cancer that cannot be removed by surgery, whose tumour is MSS or pMMR, and who have already had a platinum and taxane-based chemotherapy treatment.
• People with a life expectancy of more than 12 weeks.
• People weighing more than 30 kg.
• People whose blood counts and organ function (including blood cells, liver, and kidneys) meet specific minimum levels as assessed by the trial team.
• Women who are post-menopausal (confirmed by specific criteria related to age and menstrual history) or who have a negative pregnancy test before starting the trial.
• People who have at least one tumour that can be biopsied (minimum 10 mm across) and at least one other measurable tumour lesion.
• People willing and able to use an adequate form of contraception throughout the trial and for a set period afterwards (up to 180 days after finishing combination treatment, or 90 days after finishing single-drug treatment, whichever is longer).
• People willing and able to attend all required study visits, treatments, and follow-up appointments.

Who may not be able to join:

• People currently taking part in another clinical trial or who have received an experimental treatment within the past 4 weeks.
• People with a known immune system deficiency, or who are taking steroid or immunosuppressive medicines within 14 days before starting the trial (with some exceptions, such as low-dose steroids, inhaled or topical steroids, or steroids used to prevent allergic reactions).
• People who have received a cancer-targeting antibody treatment (monoclonal antibody) within the past 4 weeks, or who still have unresolved side effects from one received more than 4 weeks ago.
• People who have had chemotherapy, targeted therapy, hormone therapy for cancer, or radiation therapy within the past 2 weeks (hormone therapy for non-cancer reasons, such as hormone replacement therapy, is allowed).
• People who still have unresolved side effects from previous cancer treatment rated at a moderate level or above (Grade 2 or higher), with some exceptions such as hair loss or skin pigmentation changes (confirm with trial site for individual assessment).
• People who have had a major surgical procedure within 28 days before starting the trial, or who have not fully recovered from surgery.
• People with another active cancer that is growing or requiring treatment (with some exceptions, such as certain skin cancers or cervical cancer in its earliest stage).
• People who have had an organ transplant from another person.
• People with active cancer spread to the brain or cancer affecting the membranes around the brain. People with previously treated brain metastases may be considered if they are stable and meet specific conditions (confirm with trial site).
• People with active or past autoimmune or inflammatory conditions (such as inflammatory bowel disease, lupus, rheumatoid arthritis, and similar conditions), with some exceptions such as stable thyroid conditions or diet-controlled coeliac disease (confirm with trial site).
• People with current or past lung inflammation (pneumonitis) that required steroid treatment, or with a condition called interstitial lung disease.
• People with an active infection requiring treatment, including active tuberculosis, active hepatitis B, or active hepatitis C (confirm with trial site regarding past resolved infections).
• People with a known history of HIV.
• People who are pregnant, breastfeeding, or planning to become pregnant or father a child during the trial period and up to 120 days after the last dose.
• People who have previously received certain immune checkpoint therapies, including anti-PD-1, anti-PD-L1 (including durvalumab), or anti-CTLA-4 treatments (such as ipilimumab).
• People who have received a live vaccine (such as measles, mumps, rubella, chickenpox, or yellow fever vaccines) within 30 days before starting the trial.
• People with known psychiatric conditions or substance use issues that would make it difficult to follow the study requirements.
• People who, in the opinion of the treating doctor, are unlikely to follow study procedures or for whom participation would not be in their best interest.

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