This clinical trial is focused on studying treatments for endometrial cancer, specifically a type known as proficient mismatch repair (pMMR) endometrial carcinoma. The study is investigating the effectiveness and safety of a combination treatment using sacituzumab tirumotecan and pembrolizumab, compared to using pembrolizumab alone. Sacituzumab tirumotecan is a medication that targets cancer cells, while pembrolizumab is an immunotherapy drug that helps the immune system fight cancer.
The purpose of the study is to compare these treatments to see which is more effective in maintaining the health of participants with advanced or recurrent endometrial cancer. Participants will receive either the combination of sacituzumab tirumotecan and pembrolizumab or pembrolizumab alone. The study will monitor the participants’ health over time to assess the progression of the disease and overall survival rates.
Throughout the study, participants will be regularly evaluated to track their response to the treatment. This includes monitoring for any side effects and changes in their quality of life. The study aims to provide valuable information on the best treatment approach for individuals with this type of endometrial cancer.
1joining the study
Upon joining the study, participants will be informed about the trial’s purpose, procedures, and potential risks and benefits. Consent will be obtained to ensure understanding and agreement to participate.
2initial assessment
Participants will undergo an initial assessment to confirm eligibility. This includes a review of medical history and a physical examination. Imaging tests may be conducted to evaluate the current state of the endometrial cancer.
3randomization
Participants will be randomly assigned to one of two groups: one receiving sacituzumab tirumotecan in combination with pembrolizumab, and the other receiving pembrolizumab alone. This process ensures that the study results are unbiased.
4treatment administration
Participants will receive their assigned treatment. Pembrolizumab is administered as an intravenous infusion, which means it is given directly into a vein through a drip. The frequency and dosage will be determined by the study protocol and the healthcare team.
5regular monitoring
Throughout the study, participants will have regular check-ups to monitor their health and the effects of the treatment. This includes physical exams, blood tests, and imaging studies. The healthcare team will assess the cancer’s response to the treatment and any side effects experienced.
6completion of treatment
Once the treatment phase is completed, participants will undergo a final assessment. This will include a comprehensive evaluation of their health status and the effectiveness of the treatment.
7follow-up
After completing the treatment, participants will enter a follow-up phase. This involves periodic visits to monitor long-term health outcomes and any delayed side effects. The follow-up period is crucial for gathering data on the treatment’s long-term efficacy and safety.
Who Can Join the Study?
Must have a confirmed diagnosis of primary advanced or recurrent endometrial carcinoma that is proficient mismatch repair (pMMR). This means the cancer cells have a normal ability to repair DNA.
Must have disease that can be seen on imaging tests, with measurable Stage III or either measurable or non-measurable Stage IV or recurrent disease. This is determined by a set of guidelines called Response Evaluation Criteria In Solid Tumors version 1.1 (RECIST 1.1).
Must not have received any prior systemic therapy for endometrial carcinoma, except in specific cases: one prior line of systemic platinum-based adjuvant and/or neoadjuvant chemotherapy (treatments given before or after the main treatment to help improve outcomes) in a curative setting, prior radiation with or without chemotherapy that helps radiation work better if it was more than 2 weeks before starting the study treatment, or prior hormonal therapy for endometrial carcinoma that was stopped at least 1 week before starting the study treatment.
Must be female.
Must be within the age range specified by the study, which typically includes adults.
Who Cannot Join the Study?
Participants must not have any other type of cancer besides pMMR endometrial carcinoma. This is a specific type of cancer affecting the lining of the uterus.
Participants cannot be male. Only females are eligible for this study.
Participants must not be part of a vulnerable population. This means they should not be in a situation that makes them more at risk or unable to give informed consent.
Sacituzumab Tirumotecan is a type of treatment that combines a drug with an antibody. The antibody part helps the drug find and attach to cancer cells. Once attached, the drug part works to kill the cancer cells. This treatment is being tested to see if it can help people with a specific type of endometrial cancer, which is a cancer that starts in the lining of the uterus.
Pembrolizumab is a medication that helps the body’s immune system fight cancer. It works by blocking a specific protein on cancer cells, which allows the immune system to better recognize and attack these cells. This medication is already used to treat various types of cancer, and in this study, it is being tested to see how well it works as a maintenance treatment for endometrial cancer when used alone or in combination with another drug.
Endometrial Carcinoma – Endometrial carcinoma is a type of cancer that begins in the lining of the uterus, known as the endometrium. It typically starts when cells in the endometrium undergo changes and begin to grow uncontrollably, forming a tumor. As the disease progresses, the cancerous cells can invade nearby tissues and organs, such as the cervix and ovaries. In advanced stages, the cancer may spread to distant parts of the body, including the lymph nodes, lungs, and liver. The progression of endometrial carcinoma can vary, with some cases remaining localized for extended periods, while others may advance more rapidly. The disease is often associated with symptoms such as abnormal vaginal bleeding, pelvic pain, and changes in menstrual cycles.
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