Skip to content
Clinical Trials – home

Rare diseases

Investigational molecules

Locations

Our offerNewsroom

Not recruitingRare disease

Study on Carboplatin, Paclitaxel, Bevacizumab, and Rucaparib for Advanced Ovarian, Primary Peritoneal, and Fallopian Tube Cancer Patients

Verified siteRegistered drug
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 treatments for advanced stages of ovarian cancer, primary peritoneal cancer, and Fallopian tube cancer. The study involves several medications, including Carboplatin, Paclitaxel, Bevacizumab, and Rucaparib. Carboplatin and Paclitaxel are chemotherapy drugs, while Bevacizumab is a medication that helps prevent the growth of blood vessels that feed tumors. Rucaparib is a type of drug known as a PARP inhibitor, which helps repair damaged DNA in cancer cells, potentially stopping them from growing.

The purpose of this study is to compare the effectiveness of different combinations of these medications in patients with advanced ovarian, primary peritoneal, and Fallopian tube cancer. The study will explore how well these treatments work based on the Homologous Recombination Deficient (HRD) status of the patients, which is a specific characteristic of the cancer cells that can affect how they respond to treatment. The trial will begin with a phase to determine the safest dose of the combination of Rucaparib and Bevacizumab, followed by a phase to compare the progression-free survival of patients receiving different treatment combinations.

Participants in the study will receive one of the following treatment combinations: Carboplatin, Paclitaxel, and Bevacizumab; Carboplatin, Paclitaxel, Bevacizumab, and Rucaparib; or Carboplatin, Paclitaxel, and Rucaparib. The study will monitor the patients over time to assess how long they live without the cancer getting worse. The trial aims to provide valuable information on the best treatment options for patients with these types of cancer, based on their HRD status.

The research process

The trial runs in 5 steps – from screening to follow-up. Each step says what happens and what the team monitors.

  1. Step 1

    Phase I: Dose Escalation Study

    The initial phase involves determining the maximum tolerated dose of the combination of rucaparib and bevacizumab. This phase is focused on patients with advanced ovarian cancer.

    During this phase, the safety and side effects of the drug combination are closely monitored. The goal is to find the highest dose that can be given without causing severe side effects.

  2. Step 2

    Phase II: Randomized Treatment

    Patients are randomly assigned to one of three treatment groups based on their HRD status (a genetic characteristic related to DNA repair).

    The treatment groups are: Carboplatin-Paclitaxel-Bevacizumab, Carboplatin-Paclitaxel-Bevacizumab-Rucaparib, and Carboplatin-Paclitaxel-Rucaparib.

  3. Step 3

    Treatment Administration

    The medications are administered as follows: Carboplatin and Paclitaxel are given through an intravenous route, while Rucaparib is taken orally in the form of film-coated tablets.

    The specific dosages and frequency of administration are determined by the study protocol and the patient's response to treatment.

  4. Step 4

    Monitoring and Evaluation

    Throughout the trial, patients undergo regular monitoring to assess the effectiveness of the treatment and to check for any side effects.

    Progression-free survival, overall survival, and other health outcomes are measured to evaluate the success of the treatment.

  5. Step 5

    Completion and Follow-up

    The trial is expected to conclude by June 2026. After completing the treatment, patients may continue to be monitored for long-term effects and overall health outcomes.

    Follow-up assessments may include physical exams, imaging tests, and laboratory evaluations to track the patient's health status.

Who can join the trial?

8 criteria

  • Women aged 18 years or older at the time of joining the study.
  • Patients with newly diagnosed, confirmed high-grade serous or high-grade endometrioid ovarian cancer, primary peritoneal cancer, or Fallopian tube cancer. This includes patients with mixed types of cancer if more than 50% is high-grade. Stage III patients should have had one attempt at surgery to remove as much of the tumor as possible. Stage IV patients must have had either a biopsy or surgery to remove the tumor.
  • Availability of previous tumor tissue samples. If the cancer progresses, a new biopsy is optional for those willing to provide it.
  • An ECOG Performance Status of 0-1, which means the patient is fully active or has some symptoms but can still carry out light work.
  • Proper kidney and liver function, which means certain blood tests must be within specific limits. For example, total serum bilirubin should be within 1.5 times the normal limit unless the patient has a specific condition called Gilbert's syndrome.
  • Proper bone marrow function, which means certain blood cell counts must be above specific levels. For example, total white blood cells should be at least 2.5 billion per liter.
  • Able to understand and provide written consent to participate in the study.
  • Women who can have children must have a negative pregnancy test within 7 days before joining the study.

Who cannot join the trial?

4 criteria

  • Patients who do not have advanced ovarian, primary peritoneal, or Fallopian tube cancer at stage III B-C-IV.
  • Patients who are not female, as the study is only for female participants.
  • Patients who are not within the specified age range for the study.
  • Patients who are part of a vulnerable population that the study does not include.
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.

Not 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

  • Carboplatin

    is a chemotherapy medication used to treat various types of cancer, including ovarian cancer. It works by interfering with the DNA of cancer cells, preventing them from growing and dividing.

  • Paclitaxel

    is another chemotherapy drug that is used to treat different types of cancer. It helps stop the growth of cancer cells by inhibiting their ability to divide.

  • Bevacizumab

    is a targeted therapy that works by blocking a protein called VEGF. This protein helps tumors form new blood vessels, which they need to grow. By blocking VEGF, Bevacizumab can help slow or stop the growth of cancer.

  • Rucaparib

    is a type of medication known as a PARP inhibitor. It is used to treat certain types of cancer by preventing cancer cells from repairing their DNA, which can lead to their death.

What is already known about the treatment

  • Carboplatin

    This medication is administered intravenously and is commonly used in chemotherapy. It is well-established in medical literature as a treatment for various cancers, including ovarian cancer. Carboplatin is primarily indicated for advanced ovarian, primary peritoneal, and Fallopian tube cancer. It works by interfering with the DNA of cancer cells, preventing them from dividing and growing. Carboplatin is classified as a platinum-based chemotherapy drug.

  • Paclitaxel

    Administered intravenously, Paclitaxel is a widely recognized chemotherapy medication. It is used to treat several types of cancer, including advanced ovarian cancer. The drug works by stabilizing the microtubule polymer and protecting it from disassembly, which inhibits cell division. Paclitaxel is classified as a taxane, a type of antineoplastic agent.

  • Bevacizumab

    This medication is given through intravenous infusion and is used in cancer treatment. It is well-documented in medical literature for its role in treating advanced ovarian cancer. Bevacizumab is indicated for use in combination with other chemotherapy drugs to treat advanced ovarian, primary peritoneal, and Fallopian tube cancer. It works by inhibiting vascular endothelial growth factor (VEGF), which reduces the blood supply to tumors. Bevacizumab is classified as a monoclonal antibody.

  • Rucaparib

    Administered orally, Rucaparib is a newer medication in the field of oncology. It is used for treating advanced ovarian cancer, particularly in patients with homologous recombination deficiency (HRD). Rucaparib works by inhibiting the enzyme poly (ADP-ribose) polymerase (PARP), which helps repair DNA damage in cancer cells, leading to cell death. It is classified as a PARP inhibitor.

Investigated diseases

  • Ovarian Cancer

    This is a type of cancer that begins in the ovaries, which are the reproductive glands found in women. It often goes undetected until it has spread within the pelvis and abdomen. In its advanced stages, it can cause symptoms such as abdominal bloating, pelvic pain, and changes in bowel habits. The disease progresses as cancer cells grow and potentially spread to other parts of the body. It is categorized into different stages, with stage III and IV being more advanced, indicating that the cancer has spread beyond the ovaries. The progression of the disease can vary, with some cases advancing more rapidly than others.

  • Primary Peritoneal Cancer

    This cancer originates in the peritoneum, a thin layer of tissue lining the abdomen. It is similar to ovarian cancer in terms of symptoms and progression. The disease can cause abdominal pain, bloating, and digestive issues as it advances. It often spreads within the abdominal cavity, affecting nearby organs. The progression can be slow or rapid, depending on various factors, including the individual's health and the cancer's characteristics. Like ovarian cancer, it is often diagnosed at an advanced stage due to subtle early symptoms.

  • Fallopian Tube Cancer

    This rare cancer starts in the fallopian tubes, which connect the ovaries to the uterus. It shares similarities with ovarian cancer in terms of symptoms and progression. Early signs may include pelvic pain, unusual vaginal discharge, and abdominal discomfort. As the disease progresses, it can spread to nearby organs and tissues. The cancer is often detected at a later stage, making it more challenging to manage. The progression rate can vary, with some cases advancing more quickly than others.

Trial detailsLast updated 2 Oct 2026
Age18+ yearsPhasePhase IITrial ID2024-516632-99-00Protocol codeMITO 25.1Estimated enrolment300 patientsSponsorFondazione Policlinico Universitario Agostino Gemelli IRCCS

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.

ClinicalTrials.eu

Every clinical trial in Europe, in plain language.

Explore the full ecosystem of clinical research in Europe.

Search trials

Legal notice · Published by CTIN POLAND sp. z o.o., ul. rtm. Witolda Pileckiego 67/109, 02-781 Warsaw, Poland · KRS 0001111334 · REGON 528919042 · NIP 9512598637

© 2026 Clinical Trials EU – European Clinical Trials Information Network

GDPR compliance, ISO 9001 and ISO 27001 certified (LL-C Certification)

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).