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Study of Nemvaleukin Alfa and Pembrolizumab for Patients with Platinum-Resistant Ovarian, Fallopian Tube, or Primary Peritoneal 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 a type of cancer known as platinum-resistant epithelial ovarian cancer, which can also affect the fallopian tubes or the peritoneum, the lining of the abdomen. The study is testing a new treatment combination of two drugs: nemvaleukin alfa and pembrolizumab. Nemvaleukin alfa, also known by its code name ALKS 4230, is a protein-based drug, while pembrolizumab is a well-known medication used in cancer treatment. The trial will compare this combination to standard chemotherapy options chosen by the doctors involved in the study.

The purpose of the study is to evaluate how well the combination of nemvaleukin alfa and pembrolizumab works compared to chemotherapy in improving the survival of patients with this type of cancer. Participants in the study will receive either the new drug combination or chemotherapy, which may include drugs like topotecan hydrochloride, gemcitabine hydrochloride, paclitaxel, or doxorubicin hydrochloride. The treatment will be given through an intravenous infusion, which means the medication is delivered directly into the bloodstream through a vein.

Throughout the study, participants will have regular visits to monitor their health and the effects of the treatment. The study aims to gather information on overall survival, how long patients live without the cancer getting worse, and the response of the cancer to the treatment. Safety will also be closely monitored by checking for any side effects or changes in health. The study is expected to continue until 2027, providing valuable insights into the effectiveness of this new treatment approach for patients with platinum-resistant ovarian cancer.

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

    Enrollment

    Upon joining the study, the patient will be randomly assigned to one of two groups: one receiving a combination of nemvaleukin alfa and pembrolizumab, and the other receiving chemotherapy chosen by the investigator.

    The patient will provide a tumor tissue sample for testing, which may be from a previous biopsy or a new biopsy conducted during the screening phase.

  2. Step 2

    Treatment initiation

    The patient will begin treatment according to the assigned group. If assigned to the combination therapy group, the patient will receive nemvaleukin alfa and pembrolizumab via intravenous infusion.

    If assigned to the chemotherapy group, the patient will receive one of the following medications via intravenous infusion: topotecan hydrochloride, gemcitabine hydrochloride, paclitaxel, doxorubicin hydrochloride, or topotecan hydrochloride.

  3. Step 3

    Treatment schedule

    The treatment will be administered in cycles, with specific dosages and frequencies determined by the study protocol. The duration of each cycle and the number of cycles will depend on the patient's response to the treatment and the specific medication regimen.

  4. Step 4

    Monitoring and assessments

    Throughout the study, the patient will undergo regular assessments to monitor the effectiveness of the treatment and any side effects. These assessments will include physical examinations, blood tests, imaging studies, and evaluations of cancer markers.

    The patient's response to treatment will be evaluated using criteria such as progression-free survival, objective response rate, and disease control rate.

  5. Step 5

    Completion of treatment

    The treatment will continue until the patient experiences disease progression, unacceptable side effects, or chooses to withdraw from the study.

    Upon completion of the treatment, the patient will undergo a final assessment to evaluate the overall outcome and any long-term effects of the treatment.

Who can join the trial?

17 criteria

  • The patient must be a female who is 18 years of age or older.
  • The patient must have provided written informed consent, either personally or through a legal representative.
  • The patient must be willing and able to attend scheduled visits, follow the treatment schedule, and undergo laboratory tests and other study requirements.
  • The patient must have a confirmed diagnosis of one of the following cancers: epithelial ovarian cancer, fallopian tube cancer, or primary peritoneal cancer. The cancer type must be high-grade serous, endometrioid of any grade, or clear cell.
  • The patient must have platinum-resistant or refractory disease, meaning the cancer has progressed within 180 days after the last dose of platinum therapy beyond the first treatment setting.
  • The patient must have received at least one prior line of platinum-based therapy and no more than five prior lines of systemic anticancer therapy. At least one line of therapy must have included bevacizumab.
  • The patient must have at least one measurable tumor lesion that can be used to assess the response to treatment.
  • The patient must be willing to provide a tumor tissue sample, either from a previous biopsy or surgery or from a new biopsy at the time of screening.
  • The patient must have recovered from the effects of any previous cancer treatments, such as chemotherapy or surgery, with no severe side effects remaining.
  • If the patient has received prior cancer treatments, they must wait a certain period before joining the study, depending on the type of treatment.
  • The patient must have a good general health status, with an Eastern Cooperative Oncology Group (ECOG) status of 0 or 1, and an expected life expectancy of at least three months.
  • The patient must have adequate blood cell counts and hemoglobin levels, which may be supported by certain medications if needed.
  • The patient must have proper liver function, with specific limits on liver enzyme and bilirubin levels.
  • The patient must have proper kidney function, as shown by a creatinine clearance rate or serum creatinine level within acceptable limits.
  • The patient must have normal blood clotting times unless they are on blood-thinning medication, in which case the levels must be within the desired range for that medication.
  • The patient must agree to follow specific contraceptive guidelines during the study.
  • Women who can become pregnant must have a negative pregnancy test before starting the study.

Who cannot join the trial?

4 criteria

  • Patients who are not female cannot participate in the study.
  • Patients who are not within the specified age range cannot participate. The age range is not specified here, but it is important to check if you fall within the eligible age group.
  • Patients who are part of a vulnerable population may not be eligible. This means people who might need special protection or care, like those with certain disabilities or conditions.
  • Patients with medical conditions other than **Platinum-Resistant Epithelial Ovarian, Fallopian Tube, or Primary Peritoneal Cancer** cannot participate.
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Investigated drugs

  • Nemvaleukin Alfa

    is a medication being studied for its potential to help the immune system fight cancer. It is used in combination with another drug to see if it can improve survival in patients with certain types of ovarian cancer that have not responded to previous treatments.

  • Pembrolizumab

    is an immunotherapy drug that helps the body's immune system recognize and attack cancer cells. It is being tested in combination with nemvaleukin alfa to determine if this combination is more effective than standard chemotherapy in treating specific ovarian cancers.

  • Chemotherapy

    refers to the use of drugs to kill or slow the growth of cancer cells. In this study, chemotherapy is used as a comparison to see if the combination of nemvaleukin alfa and pembrolizumab offers better outcomes for patients with certain types of ovarian cancer.

What is already known about the treatment

  • Nemvaleukin Alfa

    This medication is administered intravenously and is currently being studied in clinical trials for its effectiveness in treating platinum-resistant epithelial ovarian, fallopian tube, or primary peritoneal cancer. It is not yet widely used in standard medical practice, as it is still under investigation. Nemvaleukin Alfa works by stimulating the immune system to attack cancer cells, enhancing the body's natural defenses. It is classified as an immunotherapy agent.

  • Pembrolizumab

    This medication is also administered intravenously and is used in combination with other treatments for certain types of cancer, including platinum-resistant ovarian cancer. Pembrolizumab is well-established in medical literature and is approved for various cancer treatments. It functions by blocking a specific protein on cancer cells, allowing the immune system to better recognize and destroy them. It belongs to a class of drugs known as immune checkpoint inhibitors.

Investigated diseases

Platinum-Resistant Epithelial Ovarian, Fallopian Tube, or Primary Peritoneal Cancer – This type of cancer occurs when cancerous cells form in the tissues of the ovaries, fallopian tubes, or the lining of the abdomen, known as the peritoneum. It is termed "platinum-resistant" because the cancer does not respond to chemotherapy treatments that contain platinum-based drugs. The disease often progresses as the cancer cells grow and spread to other parts of the body. Symptoms may include abdominal bloating, pain, and changes in bowel habits. As the disease advances, it can lead to more severe symptoms and complications.
Trial detailsLast updated 7 Oct 2026
Age18+ yearsPhasePhase IIITrial ID2024-513230-38-00Protocol codeALKS 4230-007Estimated enrolment455 patientsSponsorMural Oncology Inc.

sourced from the EU Clinical Trials Register and site verification

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