Testing the Addition of the Immunotherapy Drug, Pembrolizumab, to the Usual Radiation Treatment f… (NCT04214067) | Clinical Trial Compass
Active — Not RecruitingPhase 3
Testing the Addition of the Immunotherapy Drug, Pembrolizumab, to the Usual Radiation Treatment for Newly Diagnosed Early Stage High Intermediate Risk Endometrial Cancer
United States, Puerto Rico164 participantsStarted 2020-04-09
Plain-language summary
This phase III trial compares whether the addition of pembrolizumab to radiation therapy is more effective than radiation therapy alone in reducing the risk of cancer coming back (recurrence) in patients with newly diagnosed stage I-II endometrial cancer. Immunotherapy with monoclonal antibodies, such as pembrolizumab, may help the body's immune system attack the cancer, and may interfere with the ability of tumor cells to grow and spread. Radiation therapy uses high energy x-rays to kill tumor cells and shrink tumors. The addition of pembrolizumab to radiation treatment may be more effective than radiation treatment alone in reducing cancer recurrence.
Who can participate
Age range
18 Years
Sex
FEMALE
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria:
* Patients must have:
* Stage I endometrioid endometrial cancer and a combination of age and risk factors as listed below:
* Age \>= 70 and 1 or more risk factors
* Age 50 - \< 70 and 2 or more risk factors
* Age \< 50 and 3 risk factors
* Risk factors:
* Myometrial invasion \>= 50%
* Lymphovascular space invasion
* Grade 2 or 3 OR
* Stage II endometrioid endometrial cancer
* Note: Patients with isolated tumor cells in sentinel lymph nodes are eligible (considered N0i) as long as there is no evidence of micro- or macro-metastases in any lymph nodes
* CT or MRI abdomen or pelvis and either chest X-ray or CT chest demonstrating no evidence of disease outside of the uterus. Imaging can be performed pre-operatively or post-operatively. CT with contrast is the preferred modality. Positron emission tomography (PET)/CT is NOT to be used for any disease assessment or reassessment unless there is documentation that PET/CT is of diagnostic quality equal to CT with contrast
* Patients must have deficient mismatch repair as demonstrated by lack of expression of at least one mismatch repair protein by immunohistochemistry (IHC) and/or evidence of microsatellite instability (MSI) high. The institutional pathology report documenting MMR deficiency must be submitted
* Patients must have undergone surgical staging with at least hysterectomy, removal of cervix, bilateral (if both are present) salpingo-oophorectomy, and…
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1This trial is in Phase 3 and is actively running but no longer enrolling new patients — does that mean there's any chance of joining, or should we focus entirely on other options?
2The trial is measuring whether adding pembrolizumab to standard radiation improves recurrence-free survival at 3 years — based on what's known so far, does my specific tumor profile suggest I might benefit from combining immunotherapy with radiation, even outside of a trial?
3Since pembrolizumab is an immunotherapy drug being added on top of radiation, what kinds of side effects could result from that combination, and are they more serious than radiation alone?
4My diagnosis is early-stage but high-intermediate risk endometrial cancer — can you explain what puts me in that category and whether that changes which treatment approach you'd recommend for me?
5Is standard radiation therapy alone still considered a strong option for someone in my situation, and how would you compare that to pursuing a pembrolizumab combination approach through other available means?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
3 year recurrence-free survival
Timeframe: Time from study entry (randomization) to the time of withdrawal, death, or cancer recurrence, assessed at 3 years