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Active not recruitingPHASE3INTERVENTIONAL

A Study to Evaluate Dostarlimab Plus Carboplatin-paclitaxel Versus Placebo Plus Carboplatin-paclitaxel in Participants With Recurrent or Primary Advanced Endometrial Cancer

This study is investigating new treatment options for women with womb cancer that has come back (recurrent) or is advanced (Stage III or IV). It's split into two main parts. In the first part, researchers are comparing a treatment combining dostarlimab with standard chemotherapy (carboplatin-paclitaxel) followed by more dostarlimab, against standard chemotherapy plus a dummy treatment (placebo) followed by more dummy treatment. The second part adds another drug, niraparib. In this part, they're comparing dostarlimab plus chemotherapy followed by dostarlimab and niraparib, against standard chemotherapy plus dummy treatment followed by dummy treatment. The main goal is to see if these new drug combinations are more effective and safe for treating this type of cancer.

At a glance

Status
Active not recruiting
Phase
PHASE3
Sponsor
Tesaro, Inc.
Enrolment target
785
Start
18 Jul 2019
Estimated completion
26 Nov 2026

What is this study about?

This research study is focused on improving treatments for a type of cancer that starts in the womb, also known as endometrial cancer. Specifically, it's for women whose cancer has either spread (advanced) or has come back after previous treatment (recurrent).

The study aims to find out if adding a new drug called dostarlimab, and in some cases another drug called niraparib, to standard chemotherapy treatment is more effective and safe than giving chemotherapy alone with a dummy drug (placebo). Dostarlimab is a type of immunotherapy, which helps your body's immune system fight cancer cells. Niraparib is another kind of drug that can also target cancer cells.

The study is divided into two parts. In the first part, women will receive either dostarlimab combined with chemotherapy, or chemotherapy with a placebo. After the chemotherapy, they will continue with either dostarlimab alone or the placebo. The second part is similar, but after chemotherapy, some women will get both dostarlimab and niraparib, while others will continue with the placebo. By comparing these different approaches, the researchers hope to identify the best treatment strategy for women facing advanced or recurrent womb cancer.

Key takeaways

  • This study evaluates new treatments for advanced or recurrent womb cancer.
  • It combines dostarlimab and potentially niraparib with standard chemotherapy.
  • Compares these new combinations against chemotherapy plus a dummy drug (placebo).
  • Aims to find out if the new drug combinations are more effective and safe.
  • Participants must be 18+ with confirmed advanced or recurrent womb cancer.
  • Your health will be closely monitored if you take part.

Who may be eligible?

To join this study, you need to be a woman aged 18 or older with womb cancer that has been confirmed by doctors. Your cancer must either be advanced (Stage III or IV) or have come back after previous treatment (recurrent).

Specifically, if your cancer is advanced, it needs to be Stage IIIA to IIIC1 with clear signs of the disease that doctors can measure, or Stage IIIC1 with certain types of cancer cells like carcinosarcoma, clear cell, serous, or mixed types. If your cancer is Stage IIIC2 or Stage IV, you might also be eligible. If your cancer has come back, it must be the first time it's recurred, and you haven't had other cancer treatments yet for this recurrence, or it came back at least six months after your last treatment.

You also need to be generally well enough to take part, as assessed by your doctor, and your body's organs need to be working properly. For the second part of the study, your blood pressure needs to be normal or well-managed, and you must be able to take medicines by mouth.

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 a woman aged 18 or older?
  2. Do you have confirmed womb cancer that is either advanced (Stage III or IV) or has come back after treatment?
  3. If your cancer has come back, is this the first time it has recurred, or did it return at least 6 months after your last treatment?
  4. Are you generally well and able to manage daily activities without much help (ECOG performance status 0 or 1)?
  5. Are your body's major organs, such as your kidneys and liver, working properly?
  6. Can you take medication by mouth (important for Part 2 of the study)?
Answer every question to see your result.

What does participation involve?

If you decide to take part in this study, you will receive different medications depending on which study group you are assigned to. These medications will include specific doses of dostarlimab, carboplatin, paclitaxel, and potentially niraparib, or a placebo (dummy drug) that looks just like the study drugs. You will have regular visits to the clinic for assessments, which will likely include physical examinations, blood tests, and scans to monitor your health and how the treatment is working. The specific schedule of visits and treatments will vary depending on the part of the study you are in, but it will involve a period of active treatment followed by ongoing observation and follow-up. The total duration of your participation, including follow-up, will be clearly explained by the study team.

Potential risks and benefits

Taking part in a clinical trial might offer the potential benefit of accessing new treatments before they are widely available, which could be more effective for your cancer. However, all new treatments carry potential risks, including side effects from the study drugs, some of which might be serious or currently unknown. The study team will closely monitor your health for any side effects and provide care. You will be fully informed about all known risks and benefits before deciding to join, and you have the right to withdraw from the study at any time, for any reason, without it affecting your usual medical care.

Locations (169)

Some site locations are approximate. We're improving this — please verify with the trial team before travelling.
  • GSK Investigational Site
    Verified postcode
    Phoenix, United States
  • GSK Investigational Site
    Verified postcode
    Scottsdale, United States
  • GSK Investigational Site
    Verified postcode
    Tucson, United States
  • GSK Investigational Site
    Verified postcode
    Tucson, United States
  • GSK Investigational Site
    Verified postcode
    Newport Beach, United States
  • GSK Investigational Site
    Verified postcode
    Palo Alto, United States
  • GSK Investigational Site
    Verified postcode
    Deerfield Beach, United States
  • GSK Investigational Site
    Verified postcode
    Jacksonville, United States
  • GSK Investigational Site
    Verified postcode
    Miami, United States
  • GSK Investigational Site
    Verified postcode
    Miami, United States
  • GSK Investigational Site
    Verified postcode
    Orlando, United States
  • GSK Investigational Site
    Verified postcode
    Atlanta, United States

Common questions

What is endometrial cancer?

Endometrial cancer is a type of cancer that starts in the lining of the womb (uterus). It's one of the most common cancers affecting women.

What is a 'placebo'?

A placebo is a dummy treatment that looks just like the real drug but contains no active medicine. It helps researchers compare the true effects of the new treatment.

What do 'advanced' and 'recurrent' mean?

'Advanced' means the cancer has spread beyond its original location, often to other parts of the body. 'Recurrent' means the cancer has come back after it was treated previously.

What is chemotherapy?

Chemotherapy is a type of cancer treatment that uses powerful chemicals to kill fast-growing cells in your body, including cancer cells.

Will I know if I'm getting the active drugs or the placebo?

No, in this type of study, neither you nor your doctors will know whether you are receiving the active study drugs or the placebo. This helps ensure the results are unbiased and accurate.

How to find out more

Always speak to your GP or specialist before deciding to take part in a study.

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