This study focuses on patients with Stage III or IV nonmucinous epithelial ovarian cancer. The research evaluates a combination treatment using two medications: niraparib (taken as oral capsules) and dostarlimab (given through intravenous infusion), along with standard platinum-based therapy. Some patients may receive placebo instead of one or both study medications to compare the effectiveness of different treatment combinations.
The purpose of this research is to determine if adding both niraparib and dostarlimab to standard platinum-based therapy improves how long patients can live without their cancer getting worse, compared to using just niraparib with platinum-based therapy. Dostarlimab is a type of medication known as an anti-PD-1 monoclonal antibody that helps the immune system fight cancer cells, while niraparib works by blocking certain proteins that help cancer cells repair themselves.
During the study, which may last up to 72 months, participants will receive either the combination of both study medications with standard therapy, or standard therapy with just one study medication, or standard therapy with placebo. The niraparib or matching placebo will be taken daily as capsules, while dostarlimab or its matching placebo will be given through an infusion into a vein. Throughout the study, participants will have regular medical check-ups to monitor their health and how well the treatment is working.
1Initial treatment phase
You will receive a combination of platinum-based therapy with other medications. The treatment will be given through oral capsules and intravenous infusion.
The study medications include niraparib (taken as capsules) and dostarlimab (given as an infusion), or their placebos, depending on your assigned treatment group.
Your blood pressure should be stable (not higher than 140/90 mmHg) during the treatment.
2Regular health assessments
Your health status will be monitored through regular blood tests. The following values will be checked:
– Blood cell counts (without receiving blood transfusions for 2 weeks before testing)
– Kidney function through creatinine tests
– Liver function through various blood tests
You will need to complete quality of life questionnaires throughout the study period.
3Disease monitoring
Your condition will be regularly assessed to check if the cancer has progressed.
Imaging tests will be performed to measure how the tumors are responding to treatment.
The study will track how long it takes before you might need any additional cancer treatments.
4Long-term follow-up
The study will continue monitoring your health status until 2026.
Your overall survival and quality of life will be tracked throughout the study period.
If you need to start other cancer treatments, this information will be recorded as part of the study data.
Who Can Join the Study?
Must be a female aged 18 years or older
Must be diagnosed with Stage 3 or 4 non-mucinous epithelial ovarian cancer, fallopian tube cancer, or primary peritoneal cancer
Must have adequate physical performance status (ECOG score of 0 or 1, meaning able to perform daily activities with minimal limitations)
Must have normal or controlled blood pressure (systolic not higher than 140 mmHg and diastolic not higher than 90 mmHg)
Must be able to take oral medications
Must provide blood samples for testing
Must provide tumor tissue samples for laboratory analysis
Must have adequate organ function, including:
Sufficient blood cell counts
Normal kidney function
Normal liver function
If able to become pregnant, must:
Have a negative pregnancy test before starting treatment
Be post-menopausal (no periods for over 1 year)
Be surgically sterilized, or
Use effective contraception during the study and for 180 days after the last treatment
Must be willing to complete quality of life questionnaires throughout the study
Must be able to understand and agree to the study procedures by providing written informed consent
Who Cannot Join the Study?
Age below 18 years
Male patients (study is for females only)
Previous treatment with dostarlimab or niraparib (medications used in the study)
Known allergy or hypersensitivity to the study medications
Presence of mucinous ovarian cancer (a specific type of ovarian tumor)
Ovarian cancer stages other than stage 3 or 4
Presence of other active cancers requiring treatment
Severe heart conditions or uncontrolled high blood pressure
Significant liver or kidney problems
Pregnancy or breastfeeding
Participation in other clinical trials within the past 30 days
Mental conditions that could interfere with following study procedures
Active, uncontrolled infections
History of other medical conditions that could interfere with the study medications
Dostarlimab (also known as TSR-042) is a medication that helps your immune system fight cancer cells. It belongs to a group of drugs called immunotherapy. It works by blocking a protein that cancer cells use to hide from your immune system, allowing your body’s natural defenses to better recognize and attack the cancer.
Niraparib is a medication used to treat ovarian cancer. It belongs to a class of drugs called PARP inhibitors, which work by preventing cancer cells from repairing their damaged DNA, which can help stop them from growing and spreading.
Platinum-based therapy is a standard chemotherapy treatment that includes medications containing platinum. These medications work by damaging the DNA of cancer cells, which prevents them from dividing and causes them to die. This is a common first-line treatment for ovarian cancer.
Non-mucinous Epithelial Ovarian Cancer – A type of ovarian cancer that develops from the epithelial cells covering the surface of the ovary, specifically characterized by the absence of mucin-producing cells. This cancer begins in the tissue that covers the ovaries, forming solid tumors that can spread to nearby tissues. The disease typically develops in stages, with stages 3 and 4 indicating that cancer has spread beyond the ovaries. It can progress to involve nearby pelvic organs, lymph nodes, and in advanced cases, distant organs. The cancer cells in this type have distinct microscopic features that differentiate them from mucinous types of ovarian cancer.
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