All studies
Active not recruitingPHASE2INTERVENTIONAL

A Trial to Learn if Fianlimab and Cemiplimab Are Safe and Work Better Than Anti-PD1 Alone in Adult Participants With Resectable Stage 3 or 4 Melanoma

This study is investigating a new treatment for a type of skin cancer called melanoma. We're testing a combination of two drugs, fianlimab and cemiplimab, to see if it's more effective and safe than using cemiplimab by itself. These drugs are a type of 'immunotherapy,' which means they help your body's own immune system fight cancer. The study is for adults with melanoma that is at stages 3 or 4 and can be removed with surgery. Participants will receive treatment before their operation, have the surgery, and then may continue with treatment afterwards. We'll also be carefully checking for any side effects and how the drugs affect your well-being.

At a glance

Status
Active not recruiting
Phase
PHASE2
Sponsor
Regeneron Pharmaceuticals
Enrolment target
151
Start
18 Sep 2024
Estimated completion
09 Dec 2030

What is this study about?

Imagine your body has a special army, called the immune system, that usually fights off germs and diseases. Sometimes, cancer cells can hide from this army. Treatments called 'immunotherapies' are like giving your immune army special glasses to help them spot and fight cancer cells more effectively. This study is looking at two such immunotherapies: fianlimab and cemiplimab.

We want to find out if using fianlimab and cemiplimab together is a better way to treat melanoma compared to just using cemiplimab alone. Melanoma is a serious type of skin cancer. This study is specifically for people who have melanoma that is at stage 3 or 4, but can still be fully removed with surgery. The aim is to see if this combination of drugs can help stop the cancer from coming back or spreading.

Participants in the study will receive treatment before their surgery to remove the melanoma. Afterwards, they will have their operation, and then might continue with the study treatment for a period. Besides checking how well the treatment works, we will also be looking very closely at any side effects that might happen and how the drugs are handled by the body. We also want to understand if these treatments can improve a participant's quality of life.

Key takeaways

  • This study is testing two new immunotherapies for melanoma.
  • It's for people with stage 3 or 4 melanoma that can be surgically removed.
  • Treatment is given before and possibly after surgery.
  • The study aims to see if combining drugs is better than one alone.
  • Side effects and quality of life are being carefully monitored.
  • Participation involves regular clinic visits and health checks.

Who may be eligible?

This study is looking for adults aged 18 and over who have a type of skin cancer called melanoma. To be considered, your melanoma must be at stage 3 or 4, and your doctors must believe it can be completely removed through surgery.

Before joining, you'll need a full health check-up, including scans of your body and brain, to make sure you fit the study's requirements. Your general health should also be good enough that you can carry out most everyday activities without much trouble.

You won't be able to join if you have a different type of melanoma (like uveal melanoma in the eye), or if you've had certain autoimmune diseases that needed strong medicine within the last two years. Also, if you've already received other anti-cancer treatments for your current melanoma, you likely won't be eligible.

Could this study suit you?

Answer these quick questions to see if you may be eligible. This is a guide only — the research team makes the final call.

  1. Are you 18 years old or older?
  2. Do you have melanoma skin cancer (not eye melanoma)?
  3. Is your melanoma at a 'stage 3' or 'stage 4'?
  4. Has your doctor said your melanoma can be completely removed by surgery?
  5. Have you NOT received other anti-cancer treatments for this melanoma recently?
  6. Are you generally healthy enough to do most daily activities?
Answer every question to see your result.

What does participation involve?

If you join this study, you will first have a detailed check-up to make sure the study is right for you. This will involve physical exams, blood tests, and imaging scans like CT and MRI. Once enrolled, you will receive either the combined fianlimab and cemiplimab treatment, cemiplimab alone, or a placebo (a dummy treatment, which does not contain active drug) through an infusion, given into a vein.

You will receive a course of this treatment before your planned surgery to remove the melanoma. After your surgery, you will have the option to continue with the study treatment for a further period. You'll need to attend regular clinic visits for more infusions, blood tests to check how the drugs are affecting your body, and to discuss any side effects you might be experiencing. The total duration of your participation will depend on the treatment plan and your individual response.

Potential risks and benefits

Taking part in a clinical trial offers the chance to access new treatments that may turn out to be more effective than standard options. However, as these are new treatments, there's always a possibility of unknown side effects or that the treatment might not work for you. We will be carefully monitoring you for any side effects throughout the study. You will be told about all known risks before you decide to take part. Remember, joining this study is completely your choice, and you are free to withdraw at any time without giving a reason, and it will not affect your future medical care.

Locations (104)

  • UC San Diego
    Verified postcode
    La Jolla, United States
  • USC Norris Comprehensive Cancer Center
    Verified postcode
    Los Angeles, United States
  • Hoag Family Cancer Institute
    Verified postcode
    Newport Beach, United States
  • California Pacific Medical Center Research Institute
    Verified postcode
    San Francisco, United States
  • University of California San Francisco (UCSF)
    Verified postcode
    San Francisco, United States
  • St John's Cancer Institute
    Verified postcode
    Santa Monica, United States
  • University of Colorado Cancer Center
    Verified postcode
    Aurora, United States
  • Hartford Hospital
    Verified postcode
    Hartford, United States
  • Yale University Cancer Center
    Verified postcode
    New Haven, United States
  • Emory Healthcare, Emory Clinic
    Verified postcode
    Atlanta, United States
  • NorthShore University HealthSystem
    Verified postcode
    Evanston, United States
  • Massachusetts General Hospital
    Verified postcode
    Boston, United States

Common questions

What is immunotherapy?

Immunotherapy is a treatment that helps your body's own immune system find and fight cancer cells.

What is melanoma?

Melanoma is a serious type of skin cancer that starts in the cells that make skin pigment.

What does 'resectable' mean?

It means the cancer can be completely removed from your body by surgery.

Will I get a placebo?

Some participants will receive a placebo as part of the study design to fairly compare the new treatments.

How long will the study last for me?

The total length of your participation will depend on your individual treatment plan and how you respond to the medication.

How to find out more

Always speak to your GP or specialist before deciding to take part in a study.

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