Skip to content
Clinical Trials – home

Rare diseases

Investigational molecules

Locations

Our offerNewsroom

RecruitingRare disease

Study on Dostarlimab and Niraparib for Patients with Metastatic or Recurrent Endometrial or Ovarian Carcinosarcoma

Fast replyRegistered drugNo placebo
Clinical Trials Concierge

Prefer not to search? Our Concierge searches the trials for you.

What is this trial about?

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

This clinical trial is focused on studying the treatment of metastatic or recurrent endometrial or ovarian carcinosarcoma, which is a type of cancer that affects the uterus or ovaries and has either spread to other parts of the body or returned after treatment. The study is evaluating the effectiveness of two medications: dostarlimab and niraparib. Dostarlimab, also known by its code names WBP-285 and TSR-042, is given as an infusion, which means it is administered directly into the bloodstream through a vein. Niraparib is taken as a capsule by mouth.

The purpose of the study is to determine the best treatment strategy for patients with this type of cancer. Participants will receive either a combination of dostarlimab and niraparib, niraparib alone, or standard chemotherapy. The study will be conducted in two phases. In the first phase, the goal is to select the most effective treatment strategy. In the second phase, the chosen strategy will be further evaluated for its effectiveness in treating the cancer.

Participants in the study will receive treatment over a period of time and will be monitored for their response to the treatment. The study aims to assess various outcomes, including how long patients live without the cancer getting worse and their overall survival. The safety and tolerability of the treatments will also be evaluated to ensure that they are safe for patients. This study is an important step in finding better treatment options for those affected by metastatic or recurrent endometrial or ovarian carcinosarcoma.

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

    Joining the study

    Upon joining the study, you will be randomly assigned to one of the treatment groups. This means you will either receive a combination of medications or a single medication, or you may receive standard chemotherapy.

  2. Step 2

    Treatment phase

    If assigned to the combination treatment group, you will receive dostarlimab and niraparib. Dostarlimab is given as an infusion into a vein (intravenous use) at a dose of 500 mg. The frequency and duration of this treatment will be explained to you by the study team.

    If assigned to the single medication group, you will take niraparib capsules by mouth (oral use) at a dose of 100 mg. The frequency and duration of this treatment will be explained to you by the study team.

    If assigned to the chemotherapy group, you will receive standard chemotherapy treatment. The specific medications, dosage, and schedule will be explained to you by the study team.

  3. Step 3

    Monitoring and follow-up

    Throughout the study, regular visits will be scheduled to monitor your health and the effects of the treatment. This will include physical exams, blood tests, and possibly imaging tests.

    You will be asked to report any side effects or changes in your health to the study team immediately.

  4. Step 4

    End of treatment

    At the end of the treatment period, a final evaluation will be conducted to assess your response to the treatment. This may include additional tests and assessments.

    You will receive guidance on any necessary follow-up care or additional treatments that may be required after the study concludes.

Who can join the trial?

26 criteria

  • The patient must have progressive or recurrent uterine carcinosarcoma, which is a type of cancer.
  • The patient should have a life expectancy of more than 2 months.
  • The patient must have adequate bone marrow function, which means:
    • Platelet count of at least 100,000 per mm3
    • Absolute neutrophil count (ANC) of at least 1,500 per mm3
    • Hemoglobin level greater than 9 g/dL
    • The patient must have adequate liver and kidney function, which includes:
      • Total bilirubin level within certain limits unless liver metastases are present
      • Serum creatinine level within certain limits or creatinine clearance of at least 60 mL/min
      • AST and ALT levels within certain limits unless liver metastases are present
      • Alkaline phosphatase level less than 2.5 times the normal limit
      • Serum albumin level greater than 3 g/dL
      • The patient must have normal blood pressure or controlled high blood pressure.
      • If the patient is taking corticosteroids, the dose must be stable and not more than 10 mg per day for at least 4 weeks before starting the study treatment.
      • The patient must agree not to donate blood during the study and for 90 days after the last dose of study treatment.
      • If the patient is of childbearing potential, they must have a negative pregnancy test and agree to avoid pregnancy during the study and for 180 days after the last dose of study treatment.
      • The patient must agree not to breastfeed during the study and for 180 days after the last dose of study treatment.
      • The patient must be able to take oral medications.
      • The primary diagnosis must be confirmed by a pathological expert through a review of the initial tumor or biopsy at relapse.
      • The patient must be female and at least 18 years old at the time of signing the informed consent form.
      • The patient must have signed an approved informed consent form.
      • The patient must have mandatory tumor samples available from diagnosis or relapse.
      • The patient must have progressive disease as defined by specific medical criteria (RECIST 1.1).
      • The patient must have failed at least one prior platinum-containing treatment, which may have been given as part of initial treatment.
      • The patient must have had one prior chemotherapy regimen for managing carcinosarcoma.
      • The patient must be free of active infection that requires antibiotics.
      • Any hormonal therapy directed at the tumor must be stopped at least one week before starting the study treatment, but hormone replacement therapy is allowed.
      • The patient must have an ECOG Performance Status of 0 or 1, which is a measure of their ability to perform daily activities.

Who cannot join the trial?

4 criteria

  • Patients who have a different type of cancer than metastatic or recurrent endometrial or ovarian carcinosarcoma cannot participate.
  • Only female patients are eligible for this study.
  • Patients who have not received at least a first line of chemotherapy for their condition cannot participate. Chemotherapy is a type of cancer treatment that uses drugs to destroy cancer cells.
  • Patients who are considered part of a vulnerable population are not eligible. This means individuals who may have limited ability to protect their own interests, such as those with certain disabilities or conditions.
Clinical Trials Concierge

Prefer not to search? Our Concierge searches the trials for you.

Tell us about your condition – we search every trial in Europe and connect you with the right site.

We usually reply within a few days

Verified sites

All sites with verified contact details – recruitment status may not be available; ask directly

Trial locations

Where you can join this trial

Countries are shaded by recruitment status. Click a recruiting country to ask about joining there.

RecruitingNot yet recruiting
Not finding your country?

Not sure what to do next?

Joining a clinical trial can seem overwhelming. We guide you step by step, so you know exactly what to expect and how we support you through the process.

See the full process and FAQ

Investigated drugs

  • Dostarlimab

    is a type of medication known as an immune checkpoint inhibitor. It works by helping your immune system recognize and attack cancer cells. In this trial, dostarlimab is being tested to see if it can help treat metastatic or recurrent endometrial or ovarian carcinosarcoma when used in combination with another medication.

  • Niraparib

    is a medication that belongs to a class of drugs called PARP inhibitors. It works by blocking a protein that cancer cells need to repair themselves, which can help stop the cancer from growing. In this study, niraparib is being used both on its own and in combination with dostarlimab to see how effective it is in treating certain types of cancer.

What is already known about the treatment

  • Dostarlimab

    Dostarlimab is administered as an intravenous infusion, meaning it is given directly into the bloodstream through a vein. It is currently being studied in clinical trials for its effectiveness in treating metastatic or recurrent endometrial or ovarian carcinosarcoma, particularly after patients have already undergone at least one line of chemotherapy. The medication works by blocking a specific protein that cancer cells use to hide from the immune system, thereby allowing the body's natural defenses to better recognize and attack the cancer. Dostarlimab is classified as an immune checkpoint inhibitor, a type of drug that helps the immune system fight cancer.

  • Niraparib

    Niraparib is taken orally in the form of a capsule, which means it is swallowed and absorbed through the digestive system. It is being evaluated in clinical trials for its potential to treat metastatic or recurrent endometrial or ovarian carcinosarcoma, especially in patients who have previously received chemotherapy. Niraparib works by inhibiting a protein involved in repairing damaged DNA in cancer cells, leading to their death. This medication is classified as a PARP inhibitor, a type of drug that targets cancer cells with specific genetic defects.

Investigated diseases

  • Endometrial Carcinosarcoma

    Endometrial carcinosarcoma is a rare and aggressive form of cancer that arises from the uterus. It contains both carcinomatous (epithelial) and sarcomatous (mesenchymal) components. The disease typically begins in the lining of the uterus and can invade deeper tissues. It may spread to other parts of the body, including the lymph nodes, lungs, and liver. The progression of the disease can vary, but it often involves rapid growth and spread. Symptoms may include abnormal uterine bleeding, pelvic pain, and a noticeable mass in the pelvic area.

  • Ovarian Carcinosarcoma

    Ovarian carcinosarcoma is a rare and aggressive cancer that originates in the ovaries. It is characterized by the presence of both carcinomatous and sarcomatous tissue. The disease often progresses quickly, with potential spread to the abdominal cavity, lymph nodes, and distant organs. Symptoms can include abdominal swelling, pain, and changes in bowel or bladder habits. The disease may also cause unexplained weight loss and fatigue. Its progression is marked by the rapid growth of tumors and potential metastasis.

Trial detailsLast updated 7 Oct 2026
Age18+ yearsPhasePhase IITrial ID2024-516782-36-00Protocol codeGINECO-EN203bEstimated enrolment135 patientsSponsorArcagy Gineco

sourced from the EU Clinical Trials Register and site verification

Want to learn more about this trial or check if you can participate?

Clinical Trials Concierge

Prefer not to search? Our Concierge searches the trials for you.

Tell us about your condition – we search every trial in Europe and connect you with the right site.