What is the Harmony Study testing?
The purpose of the HARMONY Study is to understand if the study drugs fianlimab and cemiplimab, when used together, can help treat adults and adolescents with a type of skin cancer called melanoma. The effects of the study drugs will be compared to another medicine that is already approved to treat melanoma (pembrolizumab).
Please note that this clinical study will use an investigational drug product, the safety and efficacy of which have not been fully evaluated by Regulatory Authorities and which has not received marketing authorization in any country.
Who can participate in the study?
To be considered for the study, you must:
- Be 18 years of age or older (12 years of age or older if your country allows pediatric participants)
- Have melanoma skin cancer that cannot be fully removed with surgery (unresectable Stage 3) or has spread beyond the lymph nodes to distant sites (metastatic, Stage 4)
- Have not received systemic anti-cancer therapy for this condition (drugs that spread throughout the body, such as immunotherapy)
Please note other study criteria apply.
What happens during the study?
- Screening Period: Approximately 28 days
- Study Treatment Period & Follow-up Period: Up to 8 years
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 any side effects you experience. This decision is up to you and your doctor.
Permission
You will first need to give your consent, or permission, to join the study by reading and signing the Informed Consent Form.
Screening
To see if you qualify for the study, the study doctor will ask questions about your health, your medical history, and the medicines that you take. You will also have a checkup and some tests. You may have to provide a sample of tumour tissue (biopsy) if a previous one is not available. A biopsy is a sample of tissue taken from the body in order for it to be examined more closely.
Treatment
If you qualify for the study, you will visit the clinic about every 3 weeks to receive study treatment and to have tests to check on your health. You will also have tumour imaging tests about every 9 weeks to start, and about every 12 weeks later on.
Follow-Up
After your last dose of study treatment, you will have visits with tests to check on your health and monitor your tumour status. How often you have these visits will depend on how your cancer responded to the study treatment
What study treatment will I receive?
If you qualify for the study, you will be placed by chance into a study treatment group. You and the study doctor will not know which treatment group you are in. This helps to keep the study fair.
Group A:
fianlimab + cemiplimab (2 study drugs)
Group B:
pembrolizumab + placebo (standard treatment)
Group C:
cemiplimab + placebo (1 study drug)
How is the study treatment given?
You will receive an infusion approximately every 3 weeks.
An infusion means the study treatment is given slowly through a needle into a vein.
Each infusion will last about 30 minutes.
The placebo looks like the study treatment but contains no active medicine. This gives researchers something to compare to the study treatment so they can better understand its effects. No patient in the study will receive placebo only. Everyone will receive an active anti-cancer treatment.
What types of tests and health checks will I have at study visits?
Approximately every 3 weeks, you will have visits for tests and health checks, such as:
Vital Signs
Weight
Physical Exam
Health Status
Heart Activity
(if needed)
Blood Tests
Urine Test
(if needed)
Pregnancy Test
(if needed)
Questionnaires
(every 3 or 9 weeks)
Approximately every 9 or 12 weeks you will also have tumor imaging tests, such as:
Body Imaging
(CT and/or MRI)
Brain Imaging
Photos of Skin Tumor Sites
(if there are any)
You will not have all tests at every visit.
Throughout the study, you will also be checked for any side effects that may happen.
Find a Study Site
If you are interested in joining the HARMONY Study, search the study sites below to see if there is a location near you. You can visit clinicaltrials.gov to find sites participating in the study.