Frequently Asked Questions

You will be placed by chance into a treatment group to receive the two study drugs fianlimab and cemiplimab, a treatment option used in melanoma (pembrolizumab) with a placebo, or the study drug cemiplimab alone with a placebo.

Please note that this clinical study will use an investigational drug product, the safety and efficacy of which has not been fully evaluated by Regulatory Authorities and which has not received marketing authorization in any country.

Study medicine means that the safety and efficacy of the study drugs have not been fully evaluated and are not currently approved by country-specific regulatory health authorities to be used to treat a specific disease, but is allowed to be used for clinical research purposes.

Fianlimab, cemiplimab, and pembrolizumab work by helping your immune cells find and destroy cancer cells.

Pembrolizumab is approved in some countries as a treatment option for melanoma in adults. Cemiplimab and fianlimab are currently not approved in any country for any kind of treatment.

A placebo looks like the study drug but has no active medicine in it. This gives researchers something to compare the study treatment to in order to better understand its effects. No one in the study will receive placebo only. Everyone will receive an active anti-cancer treatment.

A computer is used to assign participants to study treatment groups by chance, like dealing from a shuffled deck of cards. This is called randomization.

There is a chance for side effects, which are unwanted and unintended effects from a medicine. Talk to the study doctor for more information on possible side effects. Your health will be closely monitored during the entire study. It is very important to tell the study doctor if you notice any changes in your health or if anything is bothering you.

You may be in the study for up to 8 years. How long you receive study treatment can depend on how well it is working and as long as any side effects you may have are manageable.

You will have study visits approximately every 3 weeks to receive study treatment and have some tests to ensure that the treatment can be continued safely. You will also have tumor imaging tests approximately every 9 weeks at the start of the study and then about every 12 weeks after that. After your last dose of study treatment, how often you come to the study site will depend on how your cancer responded to the treatment.

You may or may not directly benefit from being in the clinical study. However, you will have continuous monitoring from doctors with expertise in melanoma skin cancer, and any information collected during the study may help doctors learn more about treating others with melanoma.

There is a chance that you may have side effects from the study drugs. There may also be risks or discomfort associated with certain study procedures. Talk to the study doctor for more information.

There will be no cost to you for the study drugs, visits, tests, or supplies that are required for the study.

The biotechnology company Regeneron Pharmaceuticals is sponsoring the Harmony Study. They pay the study doctor and study site to run this study.