Recruiting

Study of nivolumab and ipilimumab combination therapy as an alternative to surgery and radiation in patients with 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 study focuses on patients with cutaneous squamous cell carcinoma, a type of skin cancer that typically requires extensive surgery and radiation therapy. The study aims to explore a different treatment approach using a combination of two medications: nivolumab and ipilimumab, which are types of immunotherapy drugs that help the body's immune system fight cancer cells.

The medications will be given through intravenous administration (delivered directly into a vein). Nivolumab (also known as OPDIVO) will be given as a solution for infusion at a dose based on body weight, while ipilimumab (also known as YERVOY) will also be administered as an infusion according to body weight. The purpose is to determine if using these medications alone can effectively treat the cancer without the need for surgery or radiation therapy.

The study will monitor patients for up to 24 months after receiving the immunotherapy treatment. During this time, doctors will evaluate how well the treatment works and track the patients' overall health. The study will look at whether patients can achieve complete removal of cancer using only these medications, without requiring additional treatments like surgery or radiation therapy.

The research process

The trial runs in 6 steps – from screening to follow-up. Each step says what happens and what the team monitors.

Step 1
Initial treatment phase
You will receive two medications through intravenous infusion (directly into your vein):
- Yervoy (ipilimumab) 5 mg/ml solution
- Opdivo (nivolumab) 10 mg/ml solution
Step 2
Medical monitoring
Regular blood tests will check your:
- White blood cell count
- Platelet levels
- Hemoglobin levels
- Liver function
- Kidney function
Your overall health status will be monitored using the WHO performance scale
Step 3
Follow-up evaluations
Your response to treatment will be evaluated at:
- 12 months after treatment
- 18 months after treatment
- 24 months after treatment
During these evaluations, your doctor will check if the treatment has been successful without requiring surgery or radiation therapy
Step 4
Quality of life assessment
You will complete quality of life questionnaires throughout the study period
These assessments help evaluate how the treatment affects your daily life and well-being
Step 5
Safety monitoring
Your doctor will monitor for any side effects related to the treatment
Any health issues that arise will be recorded and evaluated
Step 6
Long-term follow-up
The study continues until January 2029
Regular check-ups will track your health status and treatment outcomes

Who can join the trial?

10 criteria

Must be 18 years of age or older
Able to understand study information and follow treatment schedule and visits
Have UV-related skin cancer (stages I to IVa) that would normally require extensive surgery
Cancer must be located in one of these areas: - Lip border - Skin of lip - External ear - Face skin - Scalp and neck - Eyelid - Other body areas (except vulva, anus, or penis)
Have a WHO performance status of 0-2 (measure of patient's ability to perform daily activities)
Be eligible for standard surgery with or without radiation therapy
Must meet specific blood test requirements for: - White blood cells - Neutrophils (type of white blood cells) - Platelets - Hemoglobin (protein carrying oxygen in blood) - Creatinine (kidney function) - Liver function tests (AST, ALT, Bilirubin)
Women who can become pregnant must use effective birth control for 23 weeks after the last treatment
Women who can become pregnant must have a negative pregnancy test before starting treatment
Men who are sexually active with women who can become pregnant must use effective birth control for 31 weeks after the last treatment

Who cannot join the trial?

15 criteria

Presence of metastatic disease (cancer that has spread to other parts of the body)
Previous treatment with immunotherapy (treatments that help your immune system fight cancer)
Active or chronic autoimmune diseases (conditions where your immune system attacks healthy cells)
Current use of medications that suppress the immune system
Pregnancy or breastfeeding
Serious heart conditions or uncontrolled high blood pressure
History of organ transplant
Active infection requiring systemic treatment
Other active cancers requiring treatment
Known allergies to study medications
Significant mental health conditions that could affect participation
Inability to follow study procedures
Laboratory test results outside acceptable ranges
Major surgery within 4 weeks before starting the study
Participation in other clinical trials within the past 30 days

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Verified sites

All sites with verified contact details – recruitment status may not be available; ask directly

Amsterdam UMC
Responsive
Amsterdam, The Netherlands
Erasmus Universitair Medisch Centrum Rotterdam (Erasmus MC)
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Rotterdam, The Netherlands
Universitair Medisch Centrum Utrecht
Responsive
Utrecht, The Netherlands

Trial locations

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Investigated drugs

Based on the provided trial information, which focuses on immunotherapy for cutaneous squamous cell carcinoma, the main treatment involved is: Immunotherapy - A type of treatment that helps your immune system fight cancer cells. Instead of traditional cancer treatments like surgery or radiation, this therapy works by strengthening your body's natural defenses to recognize and attack cancer cells. This is a less invasive approach compared to extensive surgery and radiotherapy that are typically used for this type of skin cancer.

What is already known about the treatment

Since no specific medication names are provided in the source data, I cannot create medication descriptions in the requested format. The clinical trial data only mentions immunotherapy in general terms, without specifying particular medications. If you would like me to describe specific immunotherapy medications used in cutaneous squamous cell carcinoma treatment, please provide their names, and I will format the descriptions according to your requirements.

Investigated diseases

Cutaneous Squamous Cell Carcinoma - A type of skin cancer that develops in the squamous cells, which are the flat cells that form the outer layer of the skin. It typically appears as a firm, red nodule or a flat lesion with a scaly, crusted surface, commonly occurring on sun-exposed areas of the body. The cancer usually develops slowly and can grow into deeper layers of skin over time. This condition often results from long-term exposure to ultraviolet (UV) radiation from the sun or tanning beds. The cancer tends to form on areas of skin that receive the most sun exposure, such as the face, ears, neck, lips, and backs of hands.