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Study Comparing Paclitaxel, Carboplatin, and Oregovomab with Paclitaxel, Carboplatin, and Placebo for Patients with Advanced Ovarian Cancer

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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 advanced epithelial ovarian cancer, which can also affect the fallopian tubes or the peritoneum. The study is comparing two treatment approaches for patients who have recently been diagnosed with these conditions. One group of patients will receive a combination of chemotherapy drugs called paclitaxel and carboplatin along with a new treatment called Oregovomab. The other group will receive the same chemotherapy drugs but with a placebo instead of Oregovomab. The purpose of the study is to see if adding Oregovomab to the standard chemotherapy can help patients live longer without their cancer getting worse.

Participants in the study will receive their treatments through an infusion, which means the medication is given directly into a vein. The study will follow patients over a period of time to monitor their health and the progression of their cancer. The main goal is to determine if the addition of Oregovomab can improve the time patients live without their cancer progressing, which is known as progression-free survival. The study will also look at overall survival, which is the length of time patients live after starting the treatment, and any side effects that may occur.

This trial is designed to provide important information about the potential benefits of Oregovomab when used alongside standard chemotherapy for patients with advanced ovarian cancer. By comparing the two groups, researchers hope to find out if this new treatment can offer better outcomes for patients facing these challenging conditions.

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

    Joining the study

    Upon joining the study, participation is confirmed through a signed informed consent form. This form allows the release of personal health information necessary for the study.

  2. Step 2

    Initial treatment phase

    The treatment involves chemotherapy with paclitaxel and carboplatin. Paclitaxel is administered at a dose of 175 mg per square meter of body surface area, given intravenously every 3 weeks for 6 cycles. Carboplatin is given with an area under the curve (AUC) of 6, also intravenously every 3 weeks.

    For those who have undergone primary debulking surgery, the first cycle of chemotherapy, with or without oregovomab or placebo, is expected to start within 6 weeks after surgery.

  3. Step 3

    Interval debulking surgery

    For participants undergoing interval debulking surgery, neoadjuvant treatment with 3 cycles of paclitaxel and carboplatin is required before surgery. Paclitaxel is initially given at 175 mg per square meter, and carboplatin at AUC 5-6, both intravenously every 3 weeks.

    After surgery, participants continue with paclitaxel and carboplatin every 3 weeks starting from cycle 4, with or without oregovomab or placebo, within 6 weeks post-surgery.

  4. Step 4

    Ongoing treatment and monitoring

    Throughout the study, regular monitoring of health status and response to treatment is conducted. This includes assessments of progression-free survival and overall survival, as well as monitoring for any adverse events.

    Participants are required to complete quality of life questionnaires to assess the impact of treatment on daily living.

  5. Step 5

    Completion of study participation

    The study is estimated to conclude by August 26, 2027. Participants will continue to be monitored until the end of the study or until they choose to withdraw from the study.

Who can join the trial?

14 criteria

  • Must be an adult, 18 years old or older.
  • Must have **adequate kidney function**, meaning the creatinine level should be no more than 1.5 times the normal limit.
  • Must have an **ECOG Performance Status** of 0 or 1, which means the person is fully active or has some symptoms but can still do light work.
  • Women who can have children must agree to use a very effective form of birth control from the start of the study treatment until 6 months after the last dose.
  • Must sign a consent form agreeing to participate and allow access to personal health information.
  • Must be willing and able to fill out questionnaires about their quality of life.
  • Must have a new diagnosis of **epithelial adenocarcinoma** of the ovary, fallopian tube, or peritoneum at **FIGO Stage III or IV**, which are advanced stages of cancer.
  • Must have one of the eligible types of cancer cells, such as high-grade serous adenocarcinoma or clear cell adenocarcinoma.
  • Must have completed **debulking surgery**, which is a surgery to remove as much of the tumor as possible. This can be either primary or interval debulking surgery.
  • Must have suitable veins for the procedures required in the study.
  • Must have **CA 125 levels** of at least 50 U/mL, which is a marker used to assess ovarian cancer.
  • Must have **adequate bone marrow function**, meaning a certain level of white blood cells and platelets.
  • Must have a **hemoglobin level** of at least 8.0 g/dL, which is a measure of red blood cells. Blood transfusions are allowed up to 48 hours before the first dose of treatment.
  • Must have **adequate liver function**, meaning certain liver enzymes and bilirubin should be within specified limits.

Who cannot join the trial?

5 criteria

  • Patients who have not been diagnosed with advanced epithelial ovarian, fallopian tube, or peritoneal carcinoma cannot participate. This means the study is only for those with these specific types of cancer.
  • Patients who have not undergone optimal debulking surgery are excluded. This surgery involves removing as much of the tumor as possible.
  • Patients who are not newly diagnosed with ovarian cancer at FIGO Stage III or IV are excluded. FIGO stages describe the extent of cancer spread, with Stage III and IV being more advanced.
  • Only female patients can participate, so male patients are excluded.
  • Patients who are part of a vulnerable population may be excluded. This refers to groups who might need special protection in research, like children or those unable to give consent.
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Investigated drugs

  • Paclitaxel

    is a type of chemotherapy medication used to treat various types of cancer, including ovarian cancer. It works by stopping cancer cells from dividing and growing, which helps to slow down or stop the spread of the cancer.

  • Carboplatin

    is another chemotherapy drug that is often used in combination with other medications to treat ovarian cancer. It works by damaging the DNA of cancer cells, which prevents them from multiplying and causes them to die.

  • Oregovomab

    is an investigational medication being studied for its potential to improve the effectiveness of chemotherapy in treating ovarian cancer. It is designed to work with the body's immune system to help target and destroy cancer cells.

What is already known about the treatment

Oregovomab – Oregovomab is administered intravenously and is currently being studied in clinical trials for its potential use in treating advanced epithelial ovarian, fallopian tube, or peritoneal carcinoma. It is being evaluated in combination with chemotherapy agents paclitaxel and carboplatin. The main therapeutic indication is to improve progression-free survival in patients with newly diagnosed ovarian cancer who have undergone optimal debulking surgery. Oregovomab works by targeting and binding to a specific protein associated with cancer cells, helping the immune system recognize and attack these cells. It is classified as a monoclonal antibody, which is a type of immunotherapy.

Investigated diseases

Advanced epithelial ovarian, fallopian tube, or peritoneal carcinoma – This is a type of cancer that originates in the epithelial cells lining the ovaries, fallopian tubes, or peritoneum. It is considered advanced when it has spread beyond the ovaries to other parts of the pelvis or abdomen. The disease often progresses silently, with symptoms like abdominal bloating, pelvic pain, and changes in bowel habits appearing in later stages. As the cancer advances, it may spread to the lining of the abdomen and other organs, complicating treatment. The progression is typically monitored through imaging studies and clinical evaluations. Early detection is challenging due to the subtlety of initial symptoms.
Trial detailsLast updated 2 Oct 2026
Age18+ yearsPhasePhase IIITrial ID2024-519218-30-00Protocol codeQPT-ORE-005Estimated enrolment682 patientsSponsorCanariabio Inc.

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