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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 study about?

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.

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 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 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 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 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 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 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 Study?

  • 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 Study?

  • 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.

Where you can join this trial?

Verified and Recommended Sites

No sites found in this category

Verified Sites

Site Name City Country Status
Medizinische Universitaet Innsbruck Innsbruck Austria
Medical University Of Vienna Vienna Austria

Other Sites

Site Name City Country Status
Noe LGA Gesundheit Region Mitte GmbH St. Poelten Austria
Klinikum Wels-Grieskirchen GmbH Wels Austria
Uniklinikum Salzburg Salzburg Austria
Oeqzdjtmhvhfyf Lrra Gakz Linz Austria
Mysbcuk Udglqcuwbp Or Gufl Graz Austria

Want to learn more about this study or check if you can participate? Contact us.

Trial status

Country Status Recruitment Start
Austria Austria
Recruiting
01.10.2016

Trial locations

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.

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 ID:
2024-513637-20-00
Trial Phase:
Therapeutic exploratory (Phase II)

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