All studies
Active not recruitingPHASE3INTERVENTIONAL

Study of Pembrolizumab (MK-3475) Versus Chemotherapy in Mismatch Repair Deficient (dMMR) Advanced or Recurrent Endometrial Carcinoma (MK-3475-C93/KEYNOTE-C93/GOG-3064/ENGOT-en15)

This study, called KEYNOTE-C93, is exploring a new medicine called pembrolizumab for women with advanced or recurring womb cancer. Specifically, it's for those whose cancer cells have a particular genetic feature called 'mismatch repair deficiency' (dMMR). Researchers want to find out if pembrolizumab is more effective and safer than the usual chemotherapy combination of carboplatin and paclitaxel. The study focuses on women who haven't received chemotherapy for their advanced or recurring cancer before. The main goals are to see if pembrolizumab can keep the cancer from growing for longer and help people live longer compared to standard chemotherapy. This is a Phase 3 study, meaning it's in the later stages of testing new treatments.

At a glance

Status
Active not recruiting
Phase
PHASE3
Sponsor
Merck Sharp & Dohme LLC
Enrolment target
280
Start
03 Feb 2022
Estimated completion
27 May 2027

What is this study about?

This important study is looking into a new way to treat advanced or returning womb cancer. It's called KEYNOTE-C93. Researchers are comparing a drug called pembrolizumab with the standard chemotherapy drugs, carboplatin and paclitaxel. The aim is to see if pembrolizumab could be a better option for certain women.

The study is specifically for women whose womb cancer has a feature called 'mismatch repair deficiency', or dMMR. This means their cancer cells have a particular genetic change. Knowing this can help doctors figure out which treatments might work best. The study is particularly important for those who haven't had chemotherapy before for their advanced or returning cancer, as it explores a new first-line treatment option.

The main things the researchers want to find out are whether pembrolizumab can slow down the cancer's growth for a longer time, and if it can help women live longer, compared to the current standard chemotherapy. This trial is in its third phase, which means it’s a big study involving more people and comparing the new treatment against existing ones to understand its full benefits and risks.

Key takeaways

  • This study is for women with advanced or returning womb cancer.
  • It's specifically for those whose cancer has a 'dMMR' genetic marker.
  • The study compares a new immune therapy (pembrolizumab) with standard chemotherapy.
  • The main goals are to see if the new treatment can better control cancer growth and improve survival.
  • Participants must not have had prior chemotherapy for their advanced/recurrent cancer, with some exceptions.

Who may be eligible?

To join this study, you would need to be a woman aged 18 or older with advanced or returning womb cancer that doctors cannot remove with surgery. Your cancer also needs to have a specific genetic feature called 'mismatch repair deficiency' (dMMR).

You generally shouldn't have had chemotherapy for this advanced or returning cancer before. However, there are a few exceptions, such as if you had chemotherapy for a different reason and your cancer came back much later (at least 6 months), or if you had radiation treatment previously. It's also important to be well enough to take part, meaning you can do most of your daily activities without much help.

There are also some other important checks, for example, if you are able to become pregnant, you would need to use effective contraception during and for some time after the study treatment. The study team will review all your medical information carefully to make sure it's safe and appropriate for you to participate.

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. Are you female and over 18 years old?
  2. Do you have womb cancer that is advanced (spread) or has come back after treatment?
  3. Has your doctor told you your cancer has a 'dMMR' genetic marker?
  4. Have you *not* had chemotherapy for your advanced or recurrent womb cancer before (with some specific exceptions)?
  5. Are you generally well enough to do most daily activities on your own?
  6. If you could become pregnant, are you willing to use effective birth control during and after the trial?
Answer every question to see your result.

What does participation involve?

If you decide to take part in this study, you would receive either the new drug, pembrolizumab, or a combination of standard chemotherapy drugs (carboplatin and paclitaxel or similar options). The treatment would be given at the hospital through an IV (into a vein). During the study, you would have regular appointments for check-ups, blood tests, and scans (like CT scans) to see how you're responding to the treatment and to monitor for any side effects.

The exact number of visits and the total length of time you'd be in the study can vary. You would continue treatment as long as it is working for you and you are tolerating it well. After the treatment period, there would be a follow-up phase where doctors would continue to monitor your health. Your study doctor and nurse will explain the full schedule and what to expect in detail.

Potential risks and benefits

Taking part in a clinical trial offers potential benefits, such as gaining access to a new treatment that might be more effective than standard options, especially if current treatments haven't worked well or if approved treatments are limited. However, there are also potential risks; treatments can have side effects, which can range from mild to severe. The study doctors and nurses will closely monitor you for any side effects and manage them as best they can. It's important to remember that you are free to withdraw from the study at any time, for any reason, without it affecting your medical care.

Locations (194)

  • HonorHealth-USOR HonorHealth ( Site 8000)
    Verified postcode
    Phoenix, United States
  • Moores Cancer Center ( Site 0037)
    Verified postcode
    La Jolla, United States
  • Kaiser Permanente Riverside Medical Center ( Site 0045)
    Verified postcode
    Riverside, United States
  • Yale-New Haven Hospital-Smilow Cancer Hospital at Yale-New Haven ( Site 0013)
    Verified postcode
    New Haven, United States
  • Mount Sinai Cancer Center ( Site 0018)
    Verified postcode
    Miami Beach, United States
  • Sarasota Memorial Heath Care System ( Site 0005)
    Verified postcode
    Sarasota, United States
  • Northside Hospital ( Site 0017)
    Verified postcode
    Atlanta, United States
  • Southeastern Regional Medical Center ( Site 0046)
    Verified postcode
    Newnan, United States
  • Midwestern Regional Medical Center,Inc. DBA CTCA, Chicago ( Site 0003)
    Verified postcode
    Zion, United States
  • St. Vincent Hospital and Health Care Center, Inc ( Site 0006)
    Verified postcode
    Indianapolis, United States
  • Baptist Health Lexington ( Site 0042)
    Verified postcode
    Lexington, United States
  • Maryland Oncology Hematology, P.A.-USOR Maryland Oncology Hematology, P.A. ( Site 8002)
    Verified postcode
    Rockville, United States

Common questions

What is 'advanced or recurrent womb cancer'?

This means your womb cancer has spread beyond its original location or has come back after previous treatment.

What does 'dMMR' mean for my cancer?

dMMR stands for 'mismatch repair deficient'. It means your cancer cells have trouble fixing mistakes in their DNA, which can sometimes make them respond better to certain treatments like immunotherapy.

What is pembrolizumab?

Pembrolizumab is a type of immunotherapy. It helps your body's own immune system find and fight cancer cells.

What is 'standard chemotherapy' in this study?

The standard chemotherapy used in this study typically refers to a combination of drugs called carboplatin and paclitaxel, which are common treatments for womb cancer.

Will I know if I'm getting the new drug or chemotherapy?

This is a 'blinded' study, meaning neither you nor your study doctor will know which treatment you are receiving until after the study is complete, unless there's a medical reason to find out sooner.

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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