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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 2025

Results have been published for this study.

Primary outcome
Progression-free Survival (PFS)
Progression free survival (PFS) Note: For arm 2 (dMMR Cohort), the point estimate and the upper limit of the confidence interval are not able to be estimated due to insufficient events.
Full results on the registry

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.

  1. Do I have womb (endometrial) cancer that is advanced (Stage III or IV) or has come back?
  2. Am I at least 18 years old?
  3. Have I had a recent biopsy for my cancer?
  4. Have I not had chemotherapy for my womb cancer recently (within the last year)?
  5. Have I finished any previous radiation or hormone therapy at least 4 weeks ago?
  6. Am I generally well enough to undergo cancer treatment?
Answer every question to see your result.

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

Participating in this study might offer you access to a new treatment (pembrolizumab) that isn't yet widely available for advanced womb cancer and could potentially improve your treatment outcomes. However, there are also potential risks, as both chemotherapy and immunotherapy can cause side effects. These can range from mild, like tiredness or nausea, to more serious issues, which your doctors will discuss with you in detail. You will be closely monitored for any side effects throughout the study. Remember, deciding whether or not to join is entirely your choice, and you are free to withdraw from the study at any time, for any reason, without affecting your standard medical care.

Locations (397)

  • University of Alabama at Birmingham Cancer Center
    Verified postcode
    Birmingham, United States
  • Alaska Women's Cancer Care
    Verified postcode
    Anchorage, United States
  • CTCA at Western Regional Medical Center
    Verified postcode
    Goodyear, United States
  • NEA Baptist Memorial Hospital and Fowler Family Cancer Center - Jonesboro
    Verified postcode
    Jonesboro, United States
  • University of Arkansas for Medical Sciences
    Verified postcode
    Little Rock, United States
  • Kaiser Permanente-Baldwin Park
    Verified postcode
    Baldwin Park, United States
  • Kaiser Permanente-Bellflower
    Verified postcode
    Bellflower, United States
  • Alta Bates Summit Medical Center-Herrick Campus
    Verified postcode
    Berkeley, United States
  • Community Cancer Institute
    Verified postcode
    Clovis, United States
  • City of Hope Comprehensive Cancer Center
    Verified postcode
    Duarte, United States
  • Kaiser Permanente South Bay
    Verified postcode
    Harbor City, United States
  • Kaiser Permanente-Irvine
    Verified postcode
    Irvine, 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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