Phase 2 Ovarian 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 who have been diagnosed with endometrial (uterine) cancer that has come back (recurred), and whose cancer can be detected on scans or other tests
• People whose cancer tumours are measurable on scans — meaning at least one tumour is 10mm or larger, or lymph nodes are 15mm or larger — or whose cancer is detectable in other ways, such as fluid build-up in the abdomen or chest, or smaller lesions visible on imaging
• People whose endometrial cancer has a specific genetic feature called "mismatch repair deficiency" (dMMR) or "microsatellite instability-high" (MSI-H), confirmed by laboratory testing of their tumour tissue
• People whose cancer has been confirmed by a pathologist to be one of these types: endometrioid adenocarcinoma, mucinous adenocarcinoma, dedifferentiated or undifferentiated carcinoma, clear cell adenocarcinoma, mixed epithelial carcinoma, or adenocarcinoma not otherwise specified
• People who have had 1 to 2 previous rounds of systemic treatment (such as chemotherapy) for their cancer
• People who previously received an anti-PD-1/PD-L1 immunotherapy drug (combined with chemotherapy or radiation), provided they had a complete response to it, then their cancer came back at least 12 months after their last dose
• People who have previously had radiation therapy to the pelvis or other areas, as long as that treatment finished at least 4 weeks before joining the trial
• People who have previously received hormone therapy for their endometrial cancer, as long as it was stopped at least 3 weeks before joining
• People who have had other prior cancer treatments (chemotherapy, targeted therapy, immunotherapy, or experimental drugs), as long as those were stopped at least 4 weeks before joining (or 6 weeks for certain specific drugs — confirm with trial site)
• People aged 18 or older
• People who are reasonably well and able to carry out daily activities, as measured by a standard medical scale (ECOG score of 0, 1, or 2)
• People whose blood counts and organ function (kidneys, liver) meet certain minimum levels on blood tests (confirm specific values with trial site)
• People with adequate oxygen levels in their blood
• People whose thyroid hormone levels are within an acceptable range (or who are on thyroid replacement medication with levels managed appropriately)
• People who have recovered from recent surgery, radiation, or chemotherapy, with at least 4 weeks passed since any major surgery
• People with a history of heart disease who are assessed as being in a stable condition (New York Heart Association class 2B or better) and have a normal heart rhythm measurement on testing
• Women who could become pregnant must agree to use reliable contraception during the trial and for 5 months after the last dose, and must have a negative pregnancy test within 24 hours of starting treatment; women who are not able to become pregnant (due to menopause or prior surgery) are not required to use contraception
• Women must not be breastfeeding during the trial
• People living with HIV who are on effective treatment and have had an undetectable viral load within the past 6 months
• People with chronic hepatitis B who are on appropriate suppressive therapy and have an undetectable viral load
• People with a history of hepatitis C who have been treated and cured, or who are currently on treatment with an undetectable viral load
• People who have had brain metastases (cancer that spread to the brain) that were treated, and whose follow-up brain scans show no sign of the cancer growing back, and who have been stable without steroids for at least one month
• People who have certain pre-existing autoimmune or inflammatory conditions that are mild and well-controlled (such as vitiligo, thyroiditis managed with replacement hormones, rheumatoid arthritis or psoriasis controlled with topical treatments) may be eligible — confirm with trial site
• People who have had another type of cancer in the past or present, provided that cancer and its treatment are unlikely to interfere with this trial

Who may not be able to join:

• People whose endometrial cancer is specifically of the "serous carcinoma" or "carcinosarcoma" type
• People who previously received an anti-PD-1/PD-L1 immunotherapy drug and experienced severe (grade 3–4) or repeated moderate (grade 2) immune-related side effects that caused the treatment to be delayed or stopped
• People who have previously been treated with an anti-CTLA-4 drug or other immunotherapy that targets immune checkpoints or T-cell activity
• People who are currently taking regular steroid medications (such as prednisone) at doses higher than 10mg per day — low-dose replacement steroids may be acceptable (confirm with trial site)
• People who are taking medications that suppress the immune system, with some exceptions for inhaled, nasal, topical, or locally injected steroids, or medications used to prevent allergic reactions to treatment
• People with an active autoimmune disease, or a history of an autoimmune condition that could come back and affect vital organs or require immune-suppressing treatment — this includes conditions such as lupus, multiple sclerosis, inflammatory bowel disease, Guillain-Barré syndrome, myasthenia gravis, scleroderma, and others (confirm with trial site)
• People with known significant immune system impairment
• People with serious uncontrolled health conditions, including active infections (other than a simple urinary tract infection), lung inflammation, heart failure, unstable chest pain, irregular heart rhythm, or mental health or social circumstances that would make it difficult to follow the trial requirements
• People who are pregnant or not willing to stop breastfeeding
• People with a known history of severe allergic reactions to drugs chemically or biologically similar to the trial medications (nivolumab or ipilimumab)

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