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Study of Nivolumab and Nivolumab Plus Relatlimab for Patients with Advanced or Metastatic Skin Squamous Cell Carcinoma

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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 squamous cell carcinoma, which can be locally advanced or has spread to other parts of the body. The study involves two groups of patients. The first group will receive a treatment called Nivolumab, and the second group will receive a combination of Nivolumab and Relatlimab. These treatments are given as a solution through an infusion, which means they are administered directly into the bloodstream through a vein.

The purpose of the study is to evaluate how well these treatments work in patients with this type of skin cancer. The study will observe the patients over a period of time to see how their cancer responds to the treatment. This includes looking at how long the cancer stays under control, how long any positive response lasts, and the overall survival of the patients. The study will also monitor the safety and any side effects of the treatments.

Participants in the study will receive the treatment over a period of time, with regular check-ups to assess their health and the progress of the cancer. The study aims to provide valuable information on the effectiveness of these treatments for patients with advanced squamous cell carcinoma of the skin.

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, participation is confirmed through a written informed consent.

    Eligibility is based on specific criteria, including age, medical condition, and previous treatments.

  2. Step 2

    Initial assessment

    An initial assessment is conducted to evaluate the current state of the condition.

    This includes a review of medical history and a physical examination.

  3. Step 3

    Treatment group assignment

    Participants are assigned to one of two groups: Group 1 receives nivolumab alone, and Group 2 receives a combination of nivolumab and relatlimab.

    Both treatments are administered as a solution for infusion through a vein (intravenous use).

  4. Step 4

    Treatment administration

    The treatment is given as an infusion. The frequency and dosage are determined by the study protocol.

    The duration of treatment can last up to five years, depending on individual response and study guidelines.

  5. Step 5

    Regular monitoring

    Regular monitoring is conducted to assess the response to treatment.

    This includes imaging tests and laboratory evaluations to track the progress of the condition.

  6. Step 6

    Evaluation of response

    The response to treatment is evaluated using specific criteria to determine the effectiveness.

    This involves measuring the size of the tumor and checking for any progression or improvement.

  7. Step 7

    Follow-up

    Follow-up visits are scheduled to continue monitoring the condition and any side effects.

    These visits help ensure the safety and well-being of participants throughout the study.

Who can join the trial?

16 criteria

  • Men and women who are **18 years of age or older** on the day they sign the consent form.
  • Must have a type of skin cancer called **locally advanced or metastatic squamous cell carcinoma**, which is confirmed by a test and cannot be cured.
  • Must have a sample of the tumor available for testing specific proteins called **PD-L1 and LAG-3**.
  • Must have a disease that can be measured using specific criteria for tumors.
  • Must have a **life expectancy of at least 12 weeks**.
  • Must have a performance status score of **0 to 2** on a scale used to assess how the disease affects daily living abilities.
  • Must have certain laboratory test results within specific ranges, including:
    • White blood cells (WBC) of at least **2000 per microliter**.
    • Neutrophils of at least **1500 per microliter**.
    • Platelets of at least **100,000 per microliter**.
    • Hemoglobin greater than **9.0 grams per deciliter**.
    • Serum creatinine within a certain range or creatinine clearance of at least **40 mL/min**.
    • AST/ALT levels no more than **3 times the upper limit of normal (ULN)**.
    • Total bilirubin no more than **1.5 times the ULN**, except for those with a condition called Gilbert Syndrome.
    • Women who can have children must have a **negative pregnancy test** and use effective birth control.
    • Must have completed any prior **radiotherapy** at least 2 weeks before starting the study treatment.
    • Must have completed any prior **systemic antibiotic treatment** at least 30 days before providing a stool sample.

Who cannot join the trial?

10 criteria

  • Patients who have a different type of cancer than the one being studied.
  • Patients who have received certain treatments for their cancer that might interfere with the study.
  • Patients with other serious health conditions that could affect their safety or the study results.
  • Patients who are pregnant or breastfeeding.
  • Patients who are unable to follow the study procedures or attend required visits.
  • Patients who have allergies to the study medications.
  • Patients who are participating in another clinical trial.
  • Patients who have had a recent major surgery.
  • Patients with a history of certain infections that could affect the study.
  • Patients who have used certain medications recently that might interfere with the study.
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Investigated drugs

  • Nivolumab

    is a type of immunotherapy used in this clinical trial. It works by helping the body's immune system recognize and attack cancer cells. In this study, it is being tested on patients with advanced or metastatic squamous cell carcinoma of the skin to see how well it can improve their condition.

  • Relatlimab

    is another immunotherapy drug that is being used in combination with Nivolumab in this trial. The combination aims to enhance the immune response against cancer cells more effectively than Nivolumab alone. This combination is being tested to determine if it provides a better response in treating patients with advanced skin cancer.

What is already known about the treatment

  • Nivolumab

    Nivolumab is administered as an intravenous infusion, typically given in a clinical setting. It is currently approved and widely used in medicine for various types of cancer, including skin cancer. The main therapeutic indication for Nivolumab in this trial is for patients with locally advanced or metastatic squamous cell carcinoma of the skin. It works by blocking a protein called PD-1 on immune cells, which enhances the body's immune response against cancer cells. Nivolumab is classified as an immune checkpoint inhibitor.

  • Relatlimab

    Relatlimab is also administered via intravenous infusion, often in combination with other medications like Nivolumab. It is still under investigation in clinical trials and is not yet widely approved for use. In this trial, it is being studied for its potential to treat locally advanced or metastatic squamous cell carcinoma of the skin. Relatlimab targets the LAG-3 protein on immune cells, helping to boost the immune system's ability to fight cancer. It is classified as an immune checkpoint inhibitor.

Investigated diseases

Squamous Cell Carcinoma of the Skin – This is a type of skin cancer that begins in the squamous cells, which are flat cells located in the outer part of the skin. It often appears as a red, scaly patch, open sore, or wart-like growth that may crust or bleed. The disease can progress from a localized area to more advanced stages, where it may invade deeper layers of the skin or spread to other parts of the body. In its locally advanced or metastatic form, the cancer has spread beyond the original site to nearby tissues or distant organs. The progression of the disease can vary, with some cases remaining stable for long periods, while others may grow or spread more rapidly. Regular monitoring and assessment are crucial to understanding the disease's progression.
Trial detailsLast updated 2 Oct 2026
Age18+ yearsPhasePhase IITrial ID2024-513637-20-00Estimated enrolment61 patientsSponsorGemeinnutzige Salzburger Landes kliniken Betriebsgesellschaft mbH

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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).