Testing the Addition of the Immunotherapy Drug Pembrolizumab to the Usual Chemotherapy Treatment (Paclitaxel and Carboplatin) in Stage III-IV or Recurrent Endometrial Cancer
This research study is looking at a new way to treat womb (endometrial) cancer when it's advanced (Stage III-IV) or has returned after treatment. Doctors want to see if adding an immunotherapy drug called pembrolizumab to the usual chemotherapy drugs, paclitaxel and carboplatin, makes the treatment more effective. Immunotherapy helps your body's own immune system fight cancer. The study is comparing the new three-drug combination against the standard two-drug chemotherapy to understand if it is a better approach for patients. It's a 'Phase III' study, meaning it's comparing a new treatment against an existing standard one on a larger group of people.
At a glance
Results
Results from this study
Posted March 2025Results have been published for this study.
What is this study about?
This study is designed to find out if adding a newer type of cancer drug, called pembrolizumab, to the standard chemotherapy treatment (paclitaxel and carboplatin) can improve outcomes for people with advanced or recurrent womb cancer. Womb cancer is also known as endometrial cancer. Advanced means the cancer has spread beyond its original site, and recurrent means it has come back after previous treatment.
Pembrolizumab belongs to a group of drugs called immunotherapies. Unlike chemotherapy, which directly attacks cancer cells, immunotherapy works by boosting your body's natural defence system – your immune system – to recognise and fight the cancer more effectively. The study aims to see if this 'triple' combination is more powerful at shrinking tumours and stopping cancer from growing or spreading, compared to just the standard chemotherapy.
By comparing these two treatment approaches, researchers hope to understand which one offers patients the best chance of successful treatment, fewer side effects, and a better quality of life. This is a Phase III trial, which means it's a key stage of research done with many patients to confirm if a new treatment is effective and safe enough to become a new standard option.
Key takeaways
- This study compares standard chemotherapy with chemotherapy plus a new immunotherapy drug for advanced or recurrent womb cancer.
- Immunotherapy helps your body's immune system fight cancer.
- Participation involves regular hospital visits, treatments by infusion, and monitoring.
- You will be randomly assigned to one of two treatment groups.
- There are potential benefits from the new treatment, but also risks of side effects.
- You can stop participating in the study at any time.
Who may be eligible?
This study is looking for women who have been diagnosed with certain types of womb cancer that is either advanced (Stage III or IV) or has returned after previous treatment. Your doctors will need to check your previous test results, especially specific details about your cancer from biopsy reports.
You might be able to join if you haven't had chemotherapy for your womb cancer before, or if you had it a long time ago (at least 12 months before joining the study). You may also have had radiotherapy or hormone therapy in the past, but these treatments must have finished at least 4 weeks before you join the study. Generally, participants must be at least 18 years old.
There are also other medical checks your doctor will need to do to make sure the study treatment is safe for you. These will include checking how well your organs are working, like your heart, liver, and kidneys.
Could this study suit you?
Answer these quick questions to see if you may be eligible. This is a guide only — the research team makes the final call.
- Do I have womb (endometrial) cancer that is advanced (Stage III or IV) or has come back?
- Am I at least 18 years old?
- Have I had a recent biopsy for my cancer?
- Have I not had chemotherapy for my womb cancer recently (within the last year)?
- Have I finished any previous radiation or hormone therapy at least 4 weeks ago?
- Am I generally well enough to undergo cancer treatment?
What does participation involve?
If you decide to take part in this study, you would first have health checks, including a review of your medical history, blood tests, and scans (like CT scans) to assess your cancer. You would then be randomly assigned to receive either the standard chemotherapy (paclitaxel and carboplatin) or the standard chemotherapy plus pembrolizumab. This means a computer decides which treatment group you are in, like flipping a coin, so it's fair.
Both treatments involve receiving infusions, usually in cycles over several months. You would have regular visits to the hospital for these treatments, blood tests, and medical check-ups to monitor your health and how the treatment is working. You will also fill out questionnaires about your quality of life and how you are feeling. After the treatment phase, you would have follow-up appointments and scans to track your progress over time. The total duration of active treatment and follow-up can vary.
Potential risks and benefits
Locations (397)
- University of Alabama at Birmingham Cancer CenterVerified postcodeBirmingham, United States
- Alaska Women's Cancer CareVerified postcodeAnchorage, United States
- CTCA at Western Regional Medical CenterVerified postcodeGoodyear, United States
- NEA Baptist Memorial Hospital and Fowler Family Cancer Center - JonesboroVerified postcodeJonesboro, United States
- University of Arkansas for Medical SciencesVerified postcodeLittle Rock, United States
- Kaiser Permanente-Baldwin ParkVerified postcodeBaldwin Park, United States
- Kaiser Permanente-BellflowerVerified postcodeBellflower, United States
- Alta Bates Summit Medical Center-Herrick CampusVerified postcodeBerkeley, United States
- Community Cancer InstituteVerified postcodeClovis, United States
- City of Hope Comprehensive Cancer CenterVerified postcodeDuarte, United States
- Kaiser Permanente South BayVerified postcodeHarbor City, United States
- Kaiser Permanente-IrvineVerified postcodeIrvine, United States
Common questions
What is immunotherapy?
Immunotherapy is a treatment that helps your body's own immune system fight cancer cells more effectively.
What are Stage III-IV or recurrent endometrial cancer?
Stage III-IV means your womb cancer has spread beyond your uterus. Recurrent means the cancer has come back after treatment previously.
Will I definitely get the new drug?
No, you will be randomly assigned to either receive the usual chemotherapy or chemotherapy plus the new immunotherapy drug.
What kind of tests will I have?
You will have scans (like CT scans), blood tests, and regular check-ups to monitor your health and the cancer.
Can I stop participating in the study if I want to?
Yes, you can choose to leave the study at any time without it affecting your medical care.
How to find out more
Always speak to your GP or specialist before deciding to take part in a study.
Discussion
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