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Study on the Effectiveness and Safety of RO7198457 and Pembrolizumab for Patients with Untreated Advanced Melanoma

Verified siteRegistered drugNo placebo
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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 the treatment of Advanced Melanoma, a type of skin cancer that has spread to other parts of the body. The study is evaluating the effectiveness and safety of a new treatment combination. The treatment involves two medications: RO7198457, also known as Autogene Cevumeran, and Pembrolizumab, which is marketed under the name Keytruda. RO7198457 is a gene therapy product that uses mRNA technology, while Pembrolizumab is a type of protein-based medication that helps the immune system fight cancer.

The purpose of this study is to compare the combination of RO7198457 and Pembrolizumab against Pembrolizumab alone in patients who have not received prior treatment for their advanced melanoma. The study will monitor how long patients live without their cancer getting worse, known as progression-free survival. Participants will receive the treatments through an intravenous infusion, which means the medication is given directly into a vein. The study will last for up to 24 months, during which time the safety and effectiveness of the treatments will be closely observed.

Throughout the study, researchers will also look at other important factors, such as the overall survival of patients, the response of the cancer to the treatment, and any changes in the patients' quality of life. Additionally, the study will track any side effects experienced by participants to ensure the treatments are safe. This trial aims to provide valuable information on whether the combination of RO7198457 and Pembrolizumab offers a better treatment option for patients with advanced melanoma compared to Pembrolizumab alone.

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, the patient will be informed about the trial's purpose, which is to evaluate the effectiveness and safety of the combination of RO7198457 and pembrolizumab compared to pembrolizumab alone in treating advanced melanoma.

    The patient will be assessed to ensure they meet the inclusion criteria, such as having a confirmed diagnosis of advanced melanoma and a life expectancy of at least 12 weeks.

  2. Step 2

    Treatment administration

    The patient will receive treatment through IV infusion. The medications involved are RO7198457 and pembrolizumab.

    The specific dosage and frequency of administration will be determined by the study protocol and communicated to the patient by the healthcare team.

  3. Step 3

    Monitoring and assessments

    Throughout the trial, the patient's health will be closely monitored. This includes regular assessments of disease progression, response to treatment, and overall health status.

    The primary focus will be on progression-free survival, which measures the time during and after treatment that the patient lives without the disease worsening.

  4. Step 4

    Evaluation of secondary outcomes

    Secondary outcomes will also be evaluated, such as the objective response rate, overall survival, and duration of response.

    The patient's quality of life will be assessed using specific questionnaires, and any side effects or changes in vital signs and laboratory test results will be recorded.

  5. Step 5

    Completion of the trial

    The trial is expected to conclude by December 30, 2024. Upon completion, the patient will undergo a final assessment to evaluate the overall impact of the treatment.

    The results will contribute to understanding the effectiveness and safety of the treatment combination for advanced melanoma.

Who can join the trial?

8 criteria

  • The patient must have a type of skin cancer called advanced melanoma, which is either spread to other parts of the body (metastatic) or cannot be removed by surgery (unresectable).
  • The patient must have a confirmed diagnosis of melanoma that is either recurrent or newly diagnosed as Stage IV, or locally advanced as Stage IIIC or IIID, according to a specific cancer staging system (AJCC v8.0).
  • The patient must have an ECOG Performance Status of 0 or 1, which means they are fully active or have some symptoms but can still carry out light work.
  • The patient must have a life expectancy of at least 12 weeks.
  • The patient must have adequate blood and organ function, meaning their blood tests and organ health are within acceptable limits.
  • The patient must have measurable disease according to a specific set of guidelines (RECIST v1.1), which means the cancer can be measured in size.
  • The patient must not have received prior systemic anti-cancer therapy for advanced melanoma, except for certain cases specified in the study protocol.
  • The study is open to both male and female patients.

Who cannot join the trial?

7 criteria

  • Patients who have a different type of cancer other than advanced melanoma cannot participate. Advanced melanoma is a serious form of skin cancer that has spread to other parts of the body.
  • Patients who are not within the specified age range for the study cannot participate. The age range is typically defined by the study but is not specified here.
  • Patients who are part of a vulnerable population may not be eligible. A vulnerable population includes groups like children, pregnant women, or those unable to give consent.
  • Patients who have medical conditions or are taking medications that could interfere with the study treatment may be excluded.
  • Patients who have previously received certain treatments for melanoma that could affect the study results may not be eligible.
  • Patients who have other serious health conditions that could affect their safety or the study outcomes may be excluded.
  • Patients who are unable to follow the study procedures or attend required visits may not be eligible.
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Investigated drugs

  • RO7198457

    is an investigational medication being studied for its potential to treat advanced melanoma. It is being tested in combination with another medication to see if it can improve outcomes for patients who have not received prior treatment for their melanoma. The goal is to determine if this combination can help slow down the progression of the disease.

  • Pembrolizumab

    is a medication that is already used to treat advanced melanoma. It works by helping the immune system recognize and attack cancer cells. In this study, pembrolizumab is being used both alone and in combination with RO7198457 to compare the effectiveness of the two approaches in treating advanced melanoma.

What is already known about the treatment

  • RO7198457

    This medication is administered intravenously and is currently being studied in clinical trials for its effectiveness in treating advanced melanoma. It is not yet widely used in standard medical practice, as it is still under investigation. The main therapeutic indication is for patients with previously untreated advanced melanoma. RO7198457 works by stimulating the immune system to recognize and attack cancer cells, enhancing the body's natural defenses. It is classified as an immunotherapy agent.

  • Pembrolizumab

    This medication is administered intravenously and is an established treatment in the medical field, particularly for various types of cancer, including advanced melanoma. It is used to help the immune system detect and fight cancer cells. Pembrolizumab works by blocking a specific protein on immune cells, allowing them to better attack cancer cells. It is classified as a checkpoint inhibitor, a type of immunotherapy.

Investigated diseases

Advanced Melanoma – Advanced melanoma is a type of skin cancer that has spread beyond the original site to other parts of the body. It begins in the melanocytes, which are the cells responsible for producing the pigment melanin that colors the skin. As the disease progresses, it can invade nearby tissues and organs, making it more challenging to treat. The spread of melanoma to distant organs is known as metastasis, which can significantly affect the body's functions. Symptoms may include changes in existing moles, the appearance of new pigmented or unusual-looking growths on the skin, and other systemic symptoms depending on the organs involved. Early detection and monitoring of skin changes are crucial in managing the progression of this disease.
Trial detailsLast updated 7 Oct 2026
Age18+ yearsPhasePhase IITrial ID2023-507389-15-00Protocol codeGO40558Estimated enrolment130 patientsSponsorGenentech Inc.

sourced from the EU Clinical Trials Register and site verification

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