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Study on Niraparib and Dostarlimab for Patients with Recurrent Ovarian, Fallopian Tube, or Primary Peritoneal Cancer Not Suitable for Platinum Treatment

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What is this trial about?

A plain-language summary of the goals, design and what participants do

This clinical trial is focused on studying treatments for recurrent ovarian, fallopian tube, or primary peritoneal cancer. These are types of cancer that affect the female reproductive system and the lining of the abdomen. The study is comparing a combination of two medications, niraparib and dostarlimab, against a selection of chemotherapy treatments chosen by a doctor. Niraparib is a medication taken orally, while dostarlimab is given as an infusion, which means it is administered directly into the bloodstream through a vein.

The purpose of the study is to evaluate how these treatments affect the overall survival of patients, which means the length of time patients live after starting the treatment. Participants in the study will be randomly assigned to receive either the niraparib-dostarlimab combination or one of the chemotherapy options. The chemotherapy options may include medications such as doxorubicin hydrochloride, gemcitabine hydrochloride, bevacizumab, topotecan, or paclitaxel. These are all anti-cancer agents that work in different ways to stop the growth of cancer cells.

The study will take place over a period of up to 24 months, during which participants will receive their assigned treatment and be monitored regularly. The goal is to determine which treatment option provides the best outcomes for patients with these specific types of cancer. Participants will receive either the active treatment or a placebo, and their health will be closely observed throughout the study to ensure safety and effectiveness.

The research process

The trial runs in 4 steps – from screening to follow-up. Each step says what happens and what the team monitors.

  1. Step 1

    Randomization

    Upon joining the study, the participant is randomly assigned to one of two groups. One group receives the combination of niraparib and dostarlimab, while the other group receives a chemotherapy treatment chosen by the physician.

  2. Step 2

    Treatment administration

    Participants in the niraparib and dostarlimab group take niraparib orally once daily. Dostarlimab is administered as an intravenous infusion every three weeks.

    Participants in the chemotherapy group receive one of the following treatments, as determined by their physician: doxorubicin, gemcitabine, bevacizumab, topotecan, or paclitaxel. These medications are administered intravenously, with the specific schedule and dosage depending on the chosen drug.

  3. Step 3

    Monitoring and assessments

    Throughout the trial, participants undergo regular health assessments to monitor their response to the treatment. This includes blood tests, imaging studies, and other evaluations as needed to assess the disease status and any side effects.

  4. Step 4

    Follow-up

    After completing the treatment phase, participants enter a follow-up period. During this time, their health and disease status continue to be monitored at regular intervals to assess long-term outcomes and overall survival.

Who can join the trial?

11 criteria

  • The participant must have **recurrent ovarian, fallopian tube, or primary peritoneal cancer** and cannot be treated again with platinum-based drugs. This includes patients who are resistant to platinum (meaning the cancer came back 1-6 months after the first platinum treatment) or those who cannot take platinum due to allergies or side effects.
  • The participant must have an **Eastern Cooperative Oncology Group (ECOG) performance status** of 0 or 1, which means they are fully active or have some symptoms but can still do light work.
  • The participant must have a measurable disease or be evaluable based on **RECIST 1.1** criteria, which is a way to measure how cancer responds to treatment. Patients with only an increase in **CA 125** (a protein that can be a sign of cancer) without other evidence of disease are not included.
  • The participant must be **18 years of age or older**.
  • The participant must have adequate organ function, which includes specific levels of blood cells and liver and kidney function. This means having enough white blood cells, platelets, and hemoglobin, and normal levels of creatinine, bilirubin, and liver enzymes.
  • If the participant has high blood pressure (**hypertension**), it should be controlled before starting the study treatment.
  • The participant must agree not to donate blood during the study and for 90 days after the last dose of the study treatment.
  • The participant must agree to provide a sample of their tumor tissue, either newly obtained or from an archived specimen.
  • If the participant is a woman of childbearing potential, she must have a negative pregnancy test before starting the study and agree to avoid pregnancy during the study and for 180 days after the last dose. Women who cannot become pregnant must meet specific criteria, such as being postmenopausal or having had certain surgeries.
  • The participant must agree not to breastfeed during the study and for 180 days after the last dose of the study treatment.
  • The participant must be able to understand the study procedures and agree to participate by providing written informed consent.

Who cannot join the trial?

3 criteria

  • Patients who do not have recurrent ovarian, fallopian tube, or primary peritoneal cancer cannot participate. This means the study is only for those who have these specific types of cancer that have come back after treatment.
  • Only female patients are eligible. Male patients cannot participate in this study.
  • Patients who are considered part of a vulnerable population are not eligible. This generally refers to groups who may need special protection or care, such as children or those unable to make decisions for themselves.
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Investigated drugs

  • Niraparib

    is a medication used in this trial to treat patients with recurrent ovarian, fallopian tube, or primary peritoneal cancer. It works by blocking certain enzymes in cancer cells, which can help stop the cancer from growing and spreading.

  • Dostarlimab

    is another medication used in the trial. It is an immunotherapy drug that helps the body's immune system recognize and attack cancer cells. This can help slow down or stop the growth of cancer.

  • Chemotherapy

    refers to the use of drugs to kill or slow the growth of cancer cells. In this trial, the specific chemotherapy drugs are chosen by the physician based on the patient's condition and needs. Chemotherapy can be used to shrink tumors and improve symptoms in patients with cancer.

What is already known about the treatment

  • Niraparib

    Niraparib is administered orally in the form of capsules. It is currently being studied in clinical trials for its effectiveness in treating recurrent ovarian, fallopian tube, or primary peritoneal cancer. The main therapeutic indication for Niraparib is to help manage these types of cancers, especially in patients who are not candidates for platinum-based chemotherapy. At the molecular level, Niraparib works by inhibiting the enzyme poly (ADP-ribose) polymerase (PARP), which helps repair DNA damage in cells. By blocking this enzyme, Niraparib prevents cancer cells from repairing themselves, leading to their death. It is classified as a PARP inhibitor in pharmacology.

  • Dostarlimab

    Dostarlimab is administered intravenously and is currently under investigation in clinical trials for its potential use in treating recurrent ovarian, fallopian tube, or primary peritoneal cancer. The main therapeutic indication for Dostarlimab is to enhance the immune system's ability to fight these cancers. Its mechanism of action involves blocking the PD-1 receptor on immune cells, which can otherwise inhibit the immune response against cancer cells. By blocking this receptor, Dostarlimab helps the immune system recognize and attack cancer cells more effectively. It is classified as an immune checkpoint inhibitor.

Investigated diseases

  • Recurrent ovarian cancer

    This type of cancer occurs when ovarian cancer returns after treatment. It typically involves the growth of cancerous cells in the ovaries, which are the reproductive glands where eggs are produced. The disease may spread to nearby tissues and organs, causing symptoms such as abdominal pain, bloating, and changes in bowel habits. Over time, the cancer can become more aggressive and resistant to treatment. The progression of the disease can vary, with some patients experiencing slow growth and others facing rapid advancement. Monitoring and management are crucial to address the symptoms and complications associated with the recurrence.

  • Recurrent fallopian tube cancer

    This cancer reappears in the fallopian tubes after initial treatment. The fallopian tubes are part of the female reproductive system, connecting the ovaries to the uterus. Recurrent cancer in this area can lead to symptoms like pelvic pain, abnormal bleeding, and swelling. The disease may spread to other parts of the body, complicating the clinical picture. As the cancer progresses, it can become more challenging to manage due to potential resistance to therapies. Regular follow-up is essential to monitor the disease's behavior and address any arising issues.

  • Recurrent primary peritoneal cancer

    This cancer recurs in the peritoneum, the lining of the abdominal cavity, after previous treatment. It shares similarities with ovarian cancer in terms of symptoms and progression. Patients may experience abdominal discomfort, bloating, and digestive disturbances. The cancer can spread within the abdominal cavity and potentially to other organs. Over time, the disease may become more difficult to control, requiring ongoing assessment and management. Understanding the pattern of recurrence is important for addressing the challenges associated with this condition.

Trial detailsLast updated 2 Oct 2026
Age18+ yearsPhasePhase IIITrial ID2024-516649-38-00Protocol codeMITO 33Estimated enrolment427 patientsSponsorFondazione Policlinico Universitario Agostino Gemelli IRCCS

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On this site, “treatment” means an investigational medicine being studied in a clinical trial. Its safety and efficacy for the use being studied have not yet been confirmed, some participants may receive a placebo or a comparator medicine, and taking part does not guarantee any health benefit. The decision to take part is made by the doctor at the research site. This site is for information only and does not replace medical advice.

This service is not affiliated with the European Commission, the EMA, or the official CTIS system. Most information comes from publicly available international clinical-trial registries, supplemented by data from academic sites, national regulators and commercial sponsors. On this site, “treatment” and “therapy” mean a medicine being tested in a clinical trial. Its safety and effectiveness in the use being studied are not yet confirmed, some participants may receive a placebo or a comparator, and taking part does not guarantee a health benefit. The doctor at the research site decides who can take part. This site provides information, not medical advice. Certain content and visual elements on this website have been generated or enhanced using artificial intelligence (AI).