Not yet recruiting

Long-term follow-up study of fianlimab and cemiplimab combination treatment in adult patients with 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 study focuses on patients with melanoma, a type of skin cancer, who previously participated in a treatment program using two medications: fianlimab and cemiplimab. Both medications are given through intravenous administration (delivered directly into a vein). The purpose is to monitor the long-term health outcomes of patients who received this combination treatment.

The study will track patients who previously received treatment with LIBTAYO (also known as cemiplimab) and fianlimab (also known as REGN3767). These medications belong to a group of biological or biotechnology-derived treatments. The medications work together to help the body's immune system fight against melanoma cells.

During this extended follow-up study, researchers will monitor patients' overall survival and track how their disease responds to treatment over time. The study will also collect information about any health issues that may occur and any additional cancer treatments that patients receive after their initial treatment. This long-term monitoring will help understand how patients respond to the treatment combination over an extended period.

The research process

The trial runs in 4 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 (delivered directly into your vein):
- Cemiplimab (LIBTAYO) 350 mg as a concentrate solution for infusion
- Fianlimab as an injection solution
Step 2
Monitoring period
Your health status will be regularly monitored to assess:
- How your melanoma (skin cancer) responds to treatment
- Whether the cancer has stopped growing or spreading (disease control)
- How long the treatment benefits last (duration of response)
Any side effects or health changes will be documented during this period
Step 3
Follow-up assessments
Regular medical evaluations will track:
- Your overall survival progress
- Whether the cancer has progressed
- Any serious health issues that may occur
- Any additional cancer treatments you receive after completing the initial treatment
Step 4
Long-term observation
The study continues until October 2029
Your health status will be monitored throughout this period to understand the long-term effects of the treatment

Who can join the trial?

8 criteria

Must be diagnosed with melanoma (a type of skin cancer)
Must have previously participated in study R3767-ONC-1613 specifically in cohorts 6, 15, or 16
Must be an adult (18 years or older)
Both men and women can participate
Must be able to understand and sign an informed consent form
Must be willing to participate in follow-up visits and assessments as required by the study
Must be able to comply with all study procedures and requirements
Must be willing to have their Overall Survival (OS) (length of time from start of treatment that patient is still alive) assessed during the study

Who cannot join the trial?

12 criteria

History of autoimmune disease (conditions where the body's immune system attacks healthy cells)
Active or untreated brain metastases (cancer that has spread to the brain)
Previous treatment with any immunotherapy (treatments that help your immune system fight cancer)
Uncontrolled high blood pressure or heart disease
Active infection requiring systemic treatment (medication that affects the whole body)
Pregnant or breastfeeding women
Known allergy or sensitivity to study medications
Any other active cancer in the past 2 years (except for adequately treated non-melanoma skin cancer)
Serious medical conditions that could interfere with study participation
Immunosuppressive medication use (drugs that weaken the immune system)
History of organ transplant
Active hepatitis B or C (liver infections) or HIV infection

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Verified sites

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St Vincent's University Hospital
Verified
Dublin, Ireland

Trial locations

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Investigated drugs

Fianlimab
is a type of immunotherapy medication that helps the body's immune system fight against cancer cells. It works by targeting specific proteins that cancer cells use to evade the immune system's natural defenses.
Cemiplimab
is also an immunotherapy medication that helps activate the immune system to fight cancer cells. It belongs to a class of drugs called PD-1 inhibitors, which work by blocking certain proteins that prevent the immune system from attacking cancer cells. When used together with Fianlimab, it may provide a more effective treatment approach for melanoma patients.

What is already known about the treatment

Fianlimab
An investigational monoclonal antibody administered through intravenous infusion, currently being studied in clinical trials for the treatment of melanoma. It works by targeting immune checkpoint proteins to enhance the body's natural immune response against cancer cells, representing a form of immunotherapy. The medication belongs to the class of immune checkpoint inhibitors and is being investigated in combination with cemiplimab to potentially improve survival outcomes in melanoma patients.
Cemiplimab
A fully human monoclonal antibody delivered via intravenous infusion, approved for treating various types of cancer including advanced melanoma. It works by blocking PD-1 (programmed cell death protein 1) on T cells, which helps the immune system recognize and attack cancer cells more effectively. The medication belongs to the class of PD-1 inhibitors and has shown significant clinical benefits in treating advanced skin cancers through its immunotherapy mechanism.

Investigated diseases

Melanoma - A type of skin cancer that develops from melanocytes, the cells that produce melanin (skin pigment). The disease typically begins in a mole or appears as a new dark spot on the skin. Melanoma can develop on any part of the body, including areas not regularly exposed to sunlight. As the disease progresses, the affected area may change in size, shape, or color. The cancer can spread to other parts of the body through the lymphatic system or bloodstream. Early changes often include asymmetry in moles, irregular borders, color variations, or increasing diameter.