Study on Pembrolizumab with Chemotherapy and Possible Radiotherapy for Newly Diagnosed Endometrial Cancer After Surgery

Inclusion Criteria

• Have a confirmed new diagnosis of Endometrial Carcinoma or Carcinosarcoma.
• Have had surgery to remove the uterus and ovaries with the intent to cure the cancer.
• Be at high risk for the cancer returning after surgery, based on specific medical criteria.
• Be free of any signs of cancer after surgery and on imaging tests.
• Have not received any prior radiation or systemic therapy for endometrial cancer.
• Have a performance status score of 0 or 1, indicating full activity or some restriction in strenuous activities.
• Provide a tumor tissue sample for analysis.
• Have adequate organ function based on recent tests.

Exclusion Criteria

• Have recurrent endometrial cancer or carcinosarcoma.
• Have a different type of uterine tumor, such as endometrial stromal sarcoma or leiomyosarcoma.
• Have early-stage endometrial cancer of a specific type without certain genetic changes.
• Have a specific genetic mutation known as POLE mutation.
• Have advanced stage cancer (Stage IVB) even if no disease is present after surgery.
• Have any remaining tumor after surgery.
• Have a history of another cancer unless treated and cancer-free for 3 years, with some exceptions.
• Have received prior treatment with certain immune therapies.
• Have received a live vaccine within 30 days before starting the study treatment.
• Have an intolerance to the study treatment.
• Be participating in another clinical trial or have used an investigational device recently.
• Have any contraindication to the use of carboplatin or paclitaxel.
• Have a diagnosis of immunodeficiency or be on high-dose steroid therapy.
• Have severe allergies to pembrolizumab or its components.
• Have an active autoimmune disease requiring treatment in the past 2 years.
• Have a history of lung inflammation requiring steroids or current lung inflammation.
• Have an active infection needing treatment.
• Have a known history of HIV, Hepatitis B, or active Hepatitis C.
• Have a psychiatric or substance abuse disorder affecting study participation.
• Have had a tissue or organ transplant.
• Have not fully recovered from surgery or its complications.
• Be breastfeeding.