Active not recruitingPHASE3INTERVENTIONAL

A Comparison of Platinum-based Therapy With TSR-042 and Niraparib Versus Standard of Care (SOC) Platinum-based Therapy as First-line Treatment of Stage III or IV Nonmucinous Epithelial Ovarian Cancer

This study is for women newly diagnosed with advanced ovarian cancer (stage III or IV). It compares a newer treatment approach, which combines chemotherapy with two particular drugs called dostarlimab and niraparib, against the current standard treatment. The main goal is to find out if the new combination can help prevent the cancer from growing or spreading for a longer time. Researchers are trying to improve upon existing treatments because ovarian cancer can be complex, and they believe these drugs might target specific features of the cancer. Participants will receive initial chemotherapy, then some will get the new drug combination while others receive the standard maintenance therapy, to see which approach is more effective.

At a glance

Status

Active not recruiting

Phase

PHASE3

Sponsor

Tesaro, Inc.

Enrolment target

1,400

Start

11 Oct 2018

Estimated completion

30 Apr 2029

Ovarian Neoplasms Ovarian, Fallopian Tube and Primary Peritoneal Carcinoma

Results

Results from this study

Posted December 2025

Results have been published for this study.

Primary outcome

Progression Free Survival (PFS)

Progression Free Survival (PFS) is defined as the time from the date of randomization to the date of first documented progressive disease (PD) or death due to any cause, whichever occurs first by the Investigator assessment according to Response Evaluation Criteria in Solid Tumors Criteria (RECIST) version 1.1. Progressive Disease is defined as at least a 20% increase in the sum of the diameters of target lesions, taking as a reference, the smallest sum of diameters recorded since the treatment started (e.g. percent change from nadir, where nadir is defined as the smallest sum of diameters recorded since treatment start). In addition, the sum must have an absolute increase from nadir of 5 millimeter (mm).

Full results on the registry

What is this study about?

This research study is looking for women who have recently been diagnosed with advanced ovarian cancer. This includes cancer in the ovaries, fallopian tubes, or the lining of the abdomen, and means the cancer is classified as Stage III or IV. The study aims to see if combining standard chemotherapy with two newer drugs, called dostarlimab and niraparib, works better than the current standard treatment. The main hope is that this new combination might help keep the cancer from growing or coming back for a longer time.

Ovarian cancer can be tricky to treat, and researchers are always looking for better ways to fight it. They know that certain things can encourage ovarian cancer to grow, and the drugs dostarlimab and niraparib are designed to target some of these specific features. Dostarlimab helps the body's immune system fight cancer, while niraparib aims to fix DNA damage in cancer cells, making them less able to repair themselves.

All participants will start with standard chemotherapy. After this initial stage, they will be split into different groups. Some groups will receive the new drug combination (dostarlimab and niraparib) as an ongoing treatment (called maintenance therapy), while others will receive the standard maintenance care. By comparing these groups, doctors can learn if the new combination is more effective at controlling the cancer.

Key takeaways

New study for women with advanced ovarian cancer (Stage III or IV).
Compares new drug combination (dostarlimab + niraparib) with standard treatment.
Aims to see if the new treatment can keep cancer from growing longer.
Participation involves initial chemotherapy, then random assignment to a treatment group.
Regular hospital visits and health monitoring required.
You can withdraw from the study at any time.

Who may be eligible?

To join this study, you must be a woman aged 18 or older and fully understand what taking part involves. You need to have been diagnosed with advanced ovarian, fallopian tube, or peritoneal cancer (Stage III or IV). This diagnosis must be for a specific type of ovarian cancer (called high-grade non-mucinous epithelial).

The study is open to those whose cancer is found at Stage IV, whether it can be operated on or not, or if you're planning to have chemotherapy before surgery. If you have Stage III cancer, you might also be eligible if you meet certain detailed study requirements. You'll need to provide blood and tissue samples so researchers can carry out specific tests on your cancer.

It's important that your body organs, like your blood and kidneys, are working well enough for you to safely receive the treatments. If you could become pregnant, you'll need to have a negative pregnancy test and agree to use effective contraception throughout the study and for six months after your last treatment dose. If you've gone through menopause or had surgery preventing pregnancy, this also makes you eligible.

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.

Are you a woman aged 18 or older?
Have you been diagnosed with Stage III or IV ovarian, fallopian tube, or peritoneal cancer (high-grade non-mucinous epithelial type)?
Are your kidney, blood, and other organ functions considered healthy enough for treatment?
If you can get pregnant, are you able to use effective contraception throughout the study and for 6 months after?
Are you able to provide blood and tissue samples for testing?

Answer every question to see your result.

What does participation involve?

If you join this study, you will first receive standard chemotherapy treatments over several weeks (this is called the 'run-in period'). Then, you will be randomly assigned to one of the study treatment groups. This means you might receive a combination of dostarlimab and niraparib, or the standard care, possibly with another drug called bevacizumab, as an ongoing 'maintenance' treatment. You won't know which group you are in, and neither will your doctors, to ensure fair results.

You will have regular hospital visits for treatments, tests, and to monitor your health. This will include blood tests, scans, and physical examinations. The total duration of your participation in the study will depend on how you respond to treatment and will be explained fully by the study team. You will continue to be monitored for a period even after your main treatment finishes.

Potential risks and benefits

Participating in this study might offer the benefit of receiving a new, potentially more effective treatment combination for ovarian cancer that isn't yet widely available. However, there are potential risks, as all treatments can have side effects, and new drugs like dostarlimab and niraparib may have unknown or severe side effects. The standard treatments also have known risks. Your doctors will monitor you very closely for any issues, and you can withdraw from the study at any time without affecting your usual medical care if you decide it's not right for you.

Locations (182)

Some site locations are approximate. We're improving this — please verify with the trial team before travelling.

GSK Investigational Site
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Anchorage, United States
GSK Investigational Site
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Phoenix, United States
GSK Investigational Site
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Tucson, United States
GSK Investigational Site
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Los Angeles, United States
GSK Investigational Site
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Los Angeles, United States
GSK Investigational Site
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Newport Beach, United States
GSK Investigational Site
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Farmington, United States
GSK Investigational Site
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Hartford, United States
GSK Investigational Site
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Gainesville, United States
GSK Investigational Site
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Jacksonville, United States
GSK Investigational Site
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Geneva, United States
GSK Investigational Site
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Warrenville, United States

Common questions

What is 'standard of care' treatment?

This refers to the current best and most commonly used treatments for ovarian cancer, usually a combination of chemotherapy drugs like paclitaxel and carboplatin, sometimes with bevacizumab.

What are dostarlimab and niraparib?

Dostarlimab is a drug that helps your body's immune system fight cancer. Niraparib is another drug that helps stop cancer cells from repairing themselves, making them more vulnerable.

Will I definitely get the new drugs if I join?

No, you will be randomly assigned to either receive the new drug combination or the standard treatment. This is like flipping a coin to make sure the study is fair.

Why do I need to give blood and tissue samples?

These samples help researchers understand your cancer better and how it might respond to treatments. This also helps them learn more for future patients.

How long will I be in the study?

The exact duration can vary, but you will receive initial chemotherapy, followed by ongoing treatment and monitoring. The study team will explain the expected timeline to you.