General Study Questions
How long will I be in the study?
How long you receive the study treatment will depend on how well it is working for you and on any side effects you may experience. This decision will be up to you and your doctor. Once you have stopped receiving study treatment, how long you are in the remainder of the study will depend on how your cancer responded (whether or not it grew while taking the study treatment).
How many times will I have to go to the study site?
During the Study Treatment Period, you will have visits for tests and to receive study treatment about every 3 or 4 weeks, depending on which study treatment you receive.
During the Follow-up Period, the number of visits you have will depend on how your cancer responded to the study treatment. If your cancer does not grow, you will have visits every 90 days. If your cancer grows, you will have 1 final visit and phone calls with the study team every 3 months.
What are the benefits of being in the clinical study?
You may or may not directly benefit from being in the clinical study. However, you will have continuous monitoring from doctors with expertise in your type of cancer, and any information collected during the study may help doctors learn more about treating others with advanced melanoma.
Will it cost me anything to be in the study?
There will be no cost to you for the visits, tests, or supplies that are required solely for the study. If you are randomized to the study drug combination, this will be provided to you free of charge.
If you are randomized to the approved combination treatment comparator, that is considered standard of care. The approved combination treatment and some of the medical care that you will be given during this study is the usual care a doctor would recommend for your condition even if you were not in the study. You or your health insurance will have to pay for this usual medical care, including the approved combination treatment. You or your health insurance will also have to pay for medicines, tests, and supplies that are not required as part of the study.
If your blood was tested during the Screening Visit to see if you have been exposed to hepatitis viruses or HIV and you want to confirm (repeat) the test results, you will be responsible for the cost of this additional testing.
Who is sponsoring the study?
The biotechnology company Regeneron Pharmaceuticals is sponsoring the Harmony Head to Head Study. They pay the study doctor and study site to run this study.
What if I decide to join the study and then change my mind?
Being in the study is voluntary. If you decide to join and then change your mind, you can leave the study at any time.
Study Treatment Questions
What study treatment will I receive during the study?
If you qualify for the study, you will be placed by chance into a study treatment group to receive a combination of 2 study drugs or an already approved treatment combination for melanoma.
What does study drug mean?
Study drug means that the safety and effectiveness of the medicine has not been fully evaluated and is not currently approved by country-specific regulatory health authorities for use in treating a specific disease. It is allowed to be used for clinical research purposes only.
How are the study treatment groups assigned?
A computer will be used to assign participants to study treatment groups by chance, like dealing from a shuffled deck of cards. This is called randomization.
Are there any side effects from the study drugs?
As with all medicines, there is a chance for side effects, which are unwanted or unintended effects from a medicine. Talk to the study doctor for more information on possible side effects. Your health will be closely monitored throughout 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.