All studies
Active not recruitingPHASE3INTERVENTIONAL

Clinical Study of Fianlimab in Combination With Cemiplimab Versus Pembrolizumab in Adolescent and Adult Patients With Previously Untreated Unresectable Locally Advanced or Metastatic Melanoma

This clinical trial is investigating a new combination of treatments for advanced melanoma, a serious type of skin cancer, that has spread or cannot be removed by surgery. The study is comparing two drug approaches: an experimental combination of fianlimab and cemiplimab, versus pembrolizumab, which is already an approved treatment for melanoma. Researchers want to understand how effective the new combination is, what side effects it might cause, and how it compares to the existing treatment. They are also looking at how these treatments work differently in teenagers (12 years and older) compared to adults, and if they impact a patient's quality of life.

At a glance

Status
Active not recruiting
Phase
PHASE3
Sponsor
Regeneron Pharmaceuticals
Enrolment target
1,546
Start
14 Jul 2022
Estimated completion
16 Sep 2031

What is this study about?

This study is about finding better ways to treat advanced melanoma, a type of skin cancer that has grown or spread to other parts of the body and can't be surgically removed. Researchers are testing a new combination of two drugs, fianlimab and cemiplimab, against an existing, approved treatment called pembrolizumab. All these medications are designed to help your body's immune system fight the cancer.

The main goal is to see if the new combination of fianlimab and cemiplimab is more effective at shrinking the melanoma or stopping it from growing, compared to pembrolizumab. They also want to understand if the side effects of the new combination are different or more manageable. This is a 'Phase 3' study, which means it's one of the final steps before a new treatment might become widely available.

Another important aspect of this research is understanding how these treatments affect teenagers (aged 12 and over) differently from adults. The study also aims to measure things like the amount of drug in the bloodstream, whether the body produces antibodies against the drugs (which could make them less effective), and how the treatment might influence a patient's overall quality of life. This helps paint a complete picture of the treatment's impact beyond just tumor shrinkage.

Key takeaways

  • Compares a new drug combination to an existing treatment for advanced melanoma.
  • Aims to find more effective treatments and understand side effects.
  • Includes both adults and teenagers (12+) with advanced melanoma.
  • Involves regular check-ups, tests, and quality of life assessments.
  • Participants are closely monitored, and can leave the study at any time.

Who may be eligible?

To join this study, participants generally need to be at least 12 years old and have melanoma that has spread (Stage III or IV) or cannot be removed by surgery, and they shouldn't have received previous treatment specifically for this advanced stage of melanoma. If you had treatments for melanoma that hadn't spread, that might be okay if it was more than six months ago and your cancer hadn't progressed during that time. The type of melanoma matters too, and people with certain rare types (like eye melanoma) generally can't join.

You would also need to be generally well enough to take part, as assessed by standard health checks. This includes having good overall health and organ function. There are specific health conditions that would prevent participation, such as certain autoimmune diseases requiring strong medications, or uncontrolled infections like HIV or hepatitis. Your doctors will discuss all these criteria with you carefully to see if this study is suitable.

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 at least 12 years old?
  2. Do you have melanoma that has spread or cannot be surgically removed?
  3. Have you not had previous treatment for your advanced melanoma?
  4. Do you have good general health and a reasonable life expectancy?
  5. Do you have any autoimmune diseases requiring strong treatment, or unmanaged infections like HIV/hepatitis?
Answer every question to see your result.

What does participation involve?

If you join this study, you would receive one of the study treatments regularly, likely through an IV (drip) at a clinic. The exact schedule and number of visits would be explained by the study team. You would have regular check-ups, which include blood tests, scans (like CT or MRI) to see how the melanoma is responding, and assessments of any side effects you might experience. You'd also answer questionnaires about your quality of life. The study involves long-term follow-up to track your health and the melanoma's progress. The total duration of active treatment and follow-up will vary for each person but can last for an extended period.

Potential risks and benefits

Participating in this study might offer the potential benefit of receiving a new experimental treatment that could be effective for your melanoma, or an established treatment, with close monitoring by medical professionals. However, there are potential risks, including side effects from the study drugs, which can vary in severity. The research team will explain all known and potential side effects in detail. You are always free to withdraw from the study at any time, for any reason, without it affecting your usual medical care.

Locations (210)

Some site locations are approximate. We're improving this — please verify with the trial team before travelling.
  • UC San Diego
    Verified postcode
    La Jolla, United States
  • The Angeles Clinic and Research Institute
    Verified postcode
    Los Angeles, United States
  • Orlando Health
    Verified postcode
    Orlando, United States
  • Seidman Cancer Center
    Verified postcode
    Cleveland, United States
  • University of Tennessee Medical Center
    Verified postcode
    Knoxville, United States
  • DIABAID - Instituto de Asistencia Integral en Diabetes
    Unverified
    Ciudad Autonoma de Buenos Aires, Argentina
  • Centro Medico Austral
    Unverified
    Ciudad Autonoma de Buenos Aires, Argentina
  • Centro de Investigacion Pergamino
    Verified postcode
    Pergamino, Argentina
  • Instituto de Oncologia de Rosario
    Verified postcode
    Rosario, Argentina
  • Centro de Investigaciones Medicas y Desarrollo LC S.R.L. (LC Investigacion)
    Verified postcode
    Buenos Aires, Argentina
  • Exelsus
    Verified postcode
    San Miguel de Tucumán, Argentina
  • Gold Coast Hospital and Health Service
    Verified postcode
    Southport, Australia

Common questions

What is melanoma?

Melanoma is a serious type of skin cancer that develops in the cells that produce melanin, the pigment that gives your skin its color.

What does 'unresectable' mean?

Unresectable means the cancer cannot be completely removed by surgery, often because it has spread too widely or is in a difficult location.

Are the treatments in this study new?

One combination (fianlimab with cemiplimab) is experimental, meaning it's still being researched. Pembrolizumab, the other treatment, is an approved medication for melanoma.

Will I know which treatment I'm getting?

This is a 'blinded' study, meaning neither you nor your study doctor will usually know which specific treatment you are receiving, to ensure results are unbiased.

What if I experience side effects?

The study team will closely monitor you for side effects and will provide care and guidance on how to manage them, and adjust treatment if necessary.

How to find out more

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

Discussion

Community discussion

Powered by our forum at community.patient.info. Please be respectful — this is not medical advice.