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Study of Cemiplimab Alone and with RP1 for Patients with Advanced Skin Squamous Cell Carcinoma

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 a type of skin cancer known as Advanced Cutaneous Squamous Cell Carcinoma (CSCC). The study is evaluating the effects of a medication called Cemiplimab, which is used as a single treatment and in combination with another medication known as Vusolimogene oderparepvec (also referred to as RP1). Cemiplimab is administered through an intravenous infusion, which means it is given directly into a vein, while Vusolimogene oderparepvec is injected directly into the tumor.

The purpose of this study is to understand the potential benefits of using Cemiplimab alone compared to using it together with RP1 in patients with CSCC that has spread locally or to other parts of the body. Participants in the study will receive either Cemiplimab by itself or a combination of Cemiplimab and RP1. The study will monitor how the cancer responds to these treatments over time.

Participants will be involved in the study for a period that could last up to 108 weeks, depending on their treatment plan. During this time, they will receive regular treatments and undergo assessments to track the progress of their cancer. The study aims to gather information on how well these treatments work and their safety for patients with advanced CSCC.

The research process

The trial runs in 7 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 provide written consent to participate. This step confirms the patient's willingness and ability to follow the study's requirements.

  2. Step 2

    Initial assessment

    The patient will undergo an initial assessment to confirm eligibility. This includes checking liver function, bone marrow function, and overall health status. A diagnosis of advanced cutaneous squamous cell carcinoma (CSCC) must be confirmed.

  3. Step 3

    Treatment allocation

    The patient will be randomly assigned to receive either cemiplimab alone or in combination with vusolimogene oderparepvec. This allocation is part of the study's design to compare the effectiveness of the treatments.

  4. Step 4

    Treatment administration

    If assigned to cemiplimab alone, the patient will receive it as an intravenous infusion. The dosage is 350 mg, administered as a concentrate for solution.

    If assigned to the combination treatment, the patient will receive cemiplimab as described above, along with vusolimogene oderparepvec, which is administered through injections directly into the tumor.

  5. Step 5

    Ongoing assessments

    Throughout the study, the patient's response to treatment will be monitored. This includes regular scans and clinical assessments to evaluate the size and progression of the cancer.

  6. Step 6

    Completion of treatment

    The treatment phase will continue until the study's end date or until the patient completes the treatment protocol. The estimated end date for the study is August 15, 2025.

  7. Step 7

    Follow-up

    After completing the treatment, the patient will have follow-up visits to monitor long-term effects and overall health. This phase ensures the safety and effectiveness of the treatment over time.

Who can join the trial?

17 criteria

  • Voluntary agreement to provide written informed consent and willingness and ability to follow the study requirements.
  • **ECOG performance status**: A measure of how well a patient can perform daily activities. Patients should have a status of 0 or 1, but those with a status of 2 may be allowed if it's due to the disease being studied.
  • Must be a male or female aged 18 years or older.
  • **Hepatic function**: Liver function tests must be within certain limits. This includes:
    • Total bilirubin should be no more than 1.5 times the normal limit, unless there are liver metastases, in which case it can be up to 3 times the normal limit.
    • **Transaminases** (ALT or AST) should be no more than 3 times the normal limit, or up to 5 times if there are liver metastases.
    • **Alkaline phosphatase** should be no more than 2.5 times the normal limit, or up to 5 times if there are liver or bone metastases.
    • **Bone marrow function**: Blood tests must show:
      • Hemoglobin levels of at least 9.0 g/dL.
      • **Absolute neutrophil count** (ANC) of at least 1.5 x 109/L.
      • Platelet count of at least 100 x 109/L.
      • **Prothrombin time**: A blood test that measures how long it takes blood to clot should be no more than 1.5 times the normal limit.
      • Expected to live for more than 12 weeks.
      • Patients who can have children must agree to use effective birth control methods during the study and for 6 months after the last dose of treatment. Male patients must also agree not to donate sperm during this time.
      • For patients with **locally advanced CSCC** (a type of skin cancer):
        • Must not be suitable for surgery that could cure the cancer, or have refused surgery.
        • Must not be suitable for radiation therapy that could cure the cancer, or have refused radiation therapy.
        • Must agree to provide a sample of the tumor for review and analysis.
        • Must have a confirmed diagnosis of locally advanced or metastatic CSCC, meaning the cancer has spread beyond the original site.
        • Must have at least one measurable tumor that can be injected with treatment. The tumor should be at least 1 cm in size.

Who cannot join the trial?

9 criteria

  • Patients who have a different type of cancer other than cutaneous squamous cell carcinoma. This is a type of skin cancer.
  • Patients who are not within the specified age range for the study.
  • Patients who are part of a vulnerable population, which means they might need special protection or care.
  • Patients who are not able to follow the study procedures or instructions.
  • Patients who have a medical condition that could interfere with the study or make it unsafe for them to participate.
  • Patients who are currently participating in another clinical trial.
  • Patients who have had a recent treatment that might affect the study results.
  • Patients who are pregnant or breastfeeding.
  • Patients who have an allergy or sensitivity to the study medication.
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Investigated drugs

  • Cemiplimab

    is a medication used in this study to treat patients with advanced cutaneous squamous cell carcinoma. It is being tested to see how effective it is when used alone. Cemiplimab works by helping the immune system to recognize and attack cancer cells.

  • RP1

    is another treatment being tested in combination with cemiplimab. RP1 is designed to work alongside cemiplimab to enhance the immune system's ability to fight cancer. The study aims to determine if the combination of RP1 and cemiplimab is more effective than cemiplimab alone.

What is already known about the treatment

Cemiplimab – Cemiplimab is administered as an intravenous infusion, typically given in a clinical setting. It is currently being studied in clinical trials for its effectiveness in treating advanced cutaneous squamous cell carcinoma. The medication works by blocking a protein called PD-1 on immune cells, which helps the immune system recognize and attack cancer cells. Cemiplimab is classified as an immune checkpoint inhibitor, a type of immunotherapy that enhances the body's natural defenses to fight cancer.

Investigated diseases

Cutaneous Squamous Cell Carcinoma – This is a type of skin cancer that originates in the squamous cells, which are flat cells located in the outer part of the skin. It often appears as a rough, scaly patch or a sore that may bleed or crust over. The disease can develop on any part of the body but is most commonly found in areas frequently exposed to the sun, such as the face, ears, neck, and hands. As it progresses, it may grow larger and invade deeper layers of the skin, potentially spreading to nearby lymph nodes or other parts of the body. Early stages may be asymptomatic, but as it advances, it can cause discomfort or pain. Regular monitoring and early detection are crucial to managing its progression.
Trial detailsLast updated 7 Oct 2026
Age18+ yearsPhasePhase IITrial ID2024-512652-38-00Protocol codeRPL-002-18Estimated enrolment229 patientsSponsorReplimune Group Inc.

sourced from the EU Clinical Trials Register and site verification

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