Phase 2 Endometrial Cancer Trial, Recruiting

Written by an AI model from the 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 19 or older.
• People who have had their cancer type confirmed by a tissue sample (biopsy), with one of these specific types: endometrioid adenocarcinoma, serous adenocarcinoma, undifferentiated carcinoma, clear cell adenocarcinoma, mixed epithelial carcinoma, carcinosarcoma, or adenocarcinoma not otherwise specified.
• People with stage III, stage IVA, stage IVB, or recurrent (returned) endometrial cancer meeting specific disease measurement criteria.
• People whose cancer has been tested and confirmed as "MMR proficient" (a specific laboratory test result) by a local medical institution.
• People who have had a local laboratory test result for a protein called P53 available to provide.
• People who have not yet had their first round of systemic (whole-body) cancer treatment, OR — for those with recurrent cancer only — people whose previous systemic cancer treatment (given after surgery as a precaution) was completed at least 12 months before joining the trial. (A special exception applies to one part of the trial for people who have already received a specific three-drug combination — confirm details with the trial site.)
• People who may have had prior radiation therapy for endometrial cancer, provided it was completed at least 4 weeks before joining the trial.
• People who may have had prior hormonal therapy for endometrial cancer, provided it was stopped at least 3 weeks before joining the trial.
• People who have stored tumour tissue available, or who are able to have a fresh tissue sample taken before joining the trial.
• People with a general health and activity level rated at 0, 1, or 2 on a standard medical scale (meaning able to carry out at least some daily activities — confirm with trial site).
• People whose blood, kidney, liver, clotting, and thyroid function all meet specific healthy minimum levels, based on blood tests taken within 7 days before starting the trial.
• People who are able and willing to use effective contraception (such as hormonal methods, an IUD, or abstinence) starting before the trial, throughout treatment, and for a specified period after the last dose of each study drug (up to 6 months depending on the medication).
• People who are considered unable to become pregnant, either because they are postmenopausal (no periods for at least 12 months without another medical explanation), have had a hysterectomy and/or removal or blocking of both ovaries or fallopian tubes at least 6 weeks before joining, or have a condition that prevents pregnancy.
• People who are willing and able to give written consent to participate in the trial.

Who may not be able to join:

• People who have previously been treated with a type of drug called a PARP inhibitor.
• People with a known allergic reaction to any of the study drugs (nesuparib, pembrolizumab, or the chemotherapy components).
• People whose cancer has been confirmed as "MMR deficient" by local laboratory testing.
• People currently taking part in another clinical trial involving cancer treatment, or who have done so within the past 4 weeks.
• People with active cancer that has spread to the brain or the lining of the brain and spinal cord, unless it has been treated, shows no signs of growth on follow-up scans, and steroid medication for it was stopped at least 4 weeks ago.
• People who have had a second, separate cancer that was still growing or required active treatment within the past 2 years (with some exceptions for certain skin cancers and early-stage cervical cancer).
• People who have received a live or live-weakened vaccine within 30 days before starting the trial.
• People with an immune system condition, or who are taking steroid or other immune-suppressing medications within 7 days before joining (with some specific exceptions — confirm with trial site).
• People with a history of lung inflammation (pneumonitis) that required steroid treatment, or who currently have pneumonitis.
• People with serious uncontrolled health conditions, such as active infections, heart problems, lung disease, or mental health or social circumstances that would make it difficult to follow the trial requirements.
• People with a known history of HIV.
• People with a known history of active Hepatitis B or C infection.
• People who are unable to swallow tablets or capsules, or who have digestive conditions that would prevent medication from being properly absorbed.
• People with a known history of, or current diagnosis of, certain blood or bone marrow disorders (MDS or AML).
• People with a systemic autoimmune disease, such as Systemic Lupus Erythematosus.
• People who have not fully recovered from a major surgical procedure, or who still have ongoing surgical complications.
• People with psychiatric conditions or substance use disorders that would make it difficult to participate in the trial.
• People who are currently pregnant, breastfeeding, or planning to become pregnant during the trial period or for a specified time after the last dose of study medication.
• People who have received an organ or tissue transplant from another person.

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