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Study of Rucaparib and Nivolumab for Maintenance Treatment in Patients with Advanced Ovarian, Fallopian Tube, or Primary Peritoneal Cancer After Chemotherapy

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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 ovarian cancer, specifically in patients with advanced stages of the disease, such as high-grade epithelial ovarian cancer, fallopian tube cancer, or primary peritoneal cancer. The study is evaluating the effectiveness of two medications: Rucaparib, which is taken orally in the form of film-coated tablets, and Nivolumab (also known by its code name BMS936558), which is administered intravenously as a solution for infusion. The purpose of the study is to assess how well these treatments work as maintenance therapy after patients have responded to initial chemotherapy treatments that include platinum-based drugs.

Participants in the study will be divided into different groups to receive either the medications or a placebo. The study will compare the effects of taking Rucaparib alone, Rucaparib combined with Nivolumab, or a placebo. The trial will monitor the progression of the disease and overall survival rates among participants. The study aims to determine if these treatments can help maintain the positive effects of the initial chemotherapy and delay the progression of the cancer.

The trial will be conducted over several years, with participants receiving treatment and being monitored for any changes in their condition. The study will use specific criteria to evaluate the effectiveness of the treatments, such as the time it takes for the disease to progress or for any adverse effects to occur. The results will help determine the potential benefits of using Rucaparib and Nivolumab as part of a long-term treatment plan for patients with advanced ovarian cancer.

The research process

The trial runs in 6 steps – from screening to follow-up. Each step says what happens and what the team monitors.

  1. Step 1

    Randomization

    After completing front-line platinum-based chemotherapy and surgery, the patient is randomized within 8 weeks of the last chemotherapy cycle.

    Randomization involves being assigned to one of the study groups, which determines the treatment received.

  2. Step 2

    Treatment initiation

    The patient begins the assigned treatment regimen. This may include oral rucaparib and/or intravenous nivolumab, or placebos for these medications.

    The specific treatment arm determines the combination and form of medication received.

  3. Step 3

    Medication administration

    If assigned to receive rucaparib, the patient takes it orally in the form of film-coated tablets. Dosages may vary between 200 mg, 250 mg, or 300 mg tablets.

    If assigned to receive nivolumab, it is administered intravenously as a solution for infusion.

  4. Step 4

    Monitoring and assessments

    Throughout the trial, the patient's health and response to treatment are monitored through regular assessments.

    These assessments include imaging scans to evaluate disease progression and laboratory tests to monitor organ function and overall health.

  5. Step 5

    Progression-free survival evaluation

    The primary goal is to evaluate progression-free survival, which is the time from randomization until disease progression or death.

    This evaluation is based on criteria set by the Response Evaluation Criteria in Solid Tumors (RECIST).

  6. Step 6

    Completion of trial participation

    The trial is estimated to conclude by June 2027, at which point the patient's participation in the study ends.

    Final assessments are conducted to gather data on the long-term effects and outcomes of the treatment.

Who can join the trial?

11 criteria

  • The patient must have signed an informed consent form approved by an ethics committee before any study-specific evaluation.
  • The patient must be at least 18 years old at the time of signing the consent form. In South Korea, Taiwan, and Japan, the patient must be at least 20 years old.
  • The patient must have newly diagnosed, advanced, high-grade epithelial ovarian, fallopian tube, or primary peritoneal cancer.
  • The patient must have completed surgery to remove cancer, including the removal of both ovaries and part of the omentum, either before or after chemotherapy.
  • The patient must have received 4 to 8 cycles of first-line platinum-based chemotherapy, including at least 4 cycles of a platinum and taxane combination.
  • The patient must have completed chemotherapy and surgery with a response, meaning no evidence of disease progression as determined by the investigator.
  • The patient's CA-125 levels, a marker used to assess ovarian cancer, must meet specific criteria before treatment.
  • The patient must be randomized within 8 weeks of the first day of the last cycle of chemotherapy.
  • The patient must have enough tumor tissue available for analysis, which must be received at the central laboratory at least 3 weeks before starting treatment.
  • The patient must have adequate organ function, confirmed by specific laboratory tests, including blood, liver, and kidney function tests.
  • The patient must have an Eastern Cooperative Oncology Group (ECOG) performance status of 0 to 1, which indicates the patient's ability to carry out daily activities.

Who cannot join the trial?

5 criteria

  • Patients who have not responded to initial treatment with **platinum-based chemotherapy**. This is a type of cancer treatment that uses drugs containing the metal platinum to kill cancer cells.
  • Patients with cancer that is not classified as **advanced (FIGO stage III-IV)**. FIGO is a system used to describe how much cancer has spread. Stage III-IV means the cancer is more advanced.
  • Patients with cancer types other than **high-grade epithelial ovarian, fallopian tube, or primary peritoneal cancer**. These are specific types of cancer affecting the ovaries, fallopian tubes, or the lining of the abdomen.
  • Patients who are male, as the study is only for female participants.
  • Patients who are part of a vulnerable population, meaning they might need special protection or care.
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Investigated drugs

  • Rucaparib

    is a medication used in this trial as a maintenance treatment for ovarian cancer patients. It is taken orally and works by inhibiting a specific enzyme involved in repairing damaged DNA in cancer cells. This can help prevent the cancer cells from repairing themselves, leading to their death and potentially slowing the progression of the disease.

  • Nivolumab

    is an intravenous medication used in combination with rucaparib in this trial. It is an immunotherapy drug that helps the immune system recognize and attack cancer cells. By blocking a specific protein on the surface of immune cells, nivolumab can enhance the body's natural defenses against cancer, potentially improving the effectiveness of the treatment.

What is already known about the treatment

  • Rucaparib

    Rucaparib is administered orally and is currently being studied in clinical trials as a maintenance treatment for certain types of advanced ovarian, fallopian tube, and primary peritoneal cancers. It is a PARP inhibitor, which means it works by blocking an enzyme involved in repairing damaged DNA, thereby preventing cancer cells from repairing themselves and leading to their death. Rucaparib is classified as an antineoplastic agent and is being evaluated for its effectiveness in prolonging progression-free survival in patients who have responded to initial platinum-based chemotherapy.

  • Nivolumab

    Nivolumab is given through intravenous infusion and is being investigated in clinical trials for its potential use in combination with other treatments for advanced ovarian, fallopian tube, and primary peritoneal cancers. It is an immune checkpoint inhibitor that works by blocking the PD-1 protein on immune cells, enhancing the body's immune response against cancer cells. Nivolumab is classified as an immunotherapy drug and is being studied for its ability to improve treatment outcomes when used alongside other cancer therapies.

Investigated diseases

  • Advanced High-Grade Epithelial Ovarian Cancer

    This is a type of cancer that originates in the cells on the surface of the ovary and is characterized by high-grade tumors, indicating aggressive growth. It is typically diagnosed at an advanced stage, specifically FIGO stage III-IV, where the cancer has spread beyond the ovaries to other parts of the pelvis or abdomen. The disease often responds initially to platinum-based chemotherapy, but recurrence is common.

  • Malignant Peritoneal Neoplasm

    This refers to a cancerous growth occurring in the peritoneum, the thin layer of tissue lining the abdomen and covering most abdominal organs. It can originate from primary peritoneal cancer or be secondary, spreading from other abdominal cancers. The disease is often detected at an advanced stage due to its non-specific symptoms and can involve widespread peritoneal surfaces.

  • Ovarian Epithelial Cancer

    This cancer arises from the epithelial cells covering the ovary and is the most common type of ovarian cancer. It often presents with vague symptoms, leading to diagnosis at a later stage when the cancer has spread. The disease is known for its potential to recur after initial treatment, which typically involves surgery and chemotherapy.

  • Fallopian Tube Cancer

    A rare type of cancer that begins in the fallopian tubes, which connect the ovaries to the uterus. It shares similarities with ovarian cancer in terms of symptoms and treatment approaches. The disease is often diagnosed at an advanced stage due to its subtle early symptoms and can spread to nearby organs.

Trial detailsLast updated 2 Oct 2026
Age18+ yearsPhasePhase IIITrial ID2024-516662-11-00Protocol codeCO-338-087Estimated enrolment1 000 patientsSponsorpharmaand GmbH

sourced from the EU Clinical Trials Register and site verification

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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).