Study Treatment Questions

You will be placed by chance into a treatment group to receive the two study drugs (low dose group or high dose group) or a treatment option commonly used to prevent melanoma from returning after cancer removal surgery called pembrolizumab, with a placebo.

Study drug means that the safety and effectiveness 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.

The study drugs 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. One of the other study drugs is approved in some countries as a treatment option in other types of cancer, but currently not approved for melanoma. The third study drug is 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 drug 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.

Like with all medicines, 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.

General Study Questions

You may be in the study for up to 5 years.

You will have study visits approximately every 3 weeks for 12 months to receive study treatment and have tests to help ensure that the treatment can be continued safely. You will also have surveillance scans approximately every 12 weeks. After your last dose of study treatment, how often you come to the study site will depend on your tumor status.

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 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-Adjuvant Study. They pay the study doctor and study site to run this study.

Being in the study is completely voluntary. If you decide to join and then change your mind, you can leave the study at any time.