What is the purpose of the HARMONY-Adjuvant Study?
The purpose of the HARMONY-Adjuvant Study is to understand if the study drugs, when given together for 1 year, are well-tolerated and more effective than a commonly prescribed melanoma drug called pembrolizumab in treating adults and adolescents aged 12 years or older who are melanoma-free following surgery but at high risk of their cancer reappearing. (Adjuvant treatment is treatment after surgery to reduce the chances of cancer coming back).
Who can participate in the study?
To be considered for the study, you must:
- Be 12 years of age or older (if your country and ethics committee allow pediatric participants).
- Have melanoma skin cancer that is localized (Stage 2), has spread to the lymph nodes (Stage 3), or has spread beyond the lymph nodes to other parts of the body (Stage 4, metastatic) that has been completely removed with surgery.
- Have no evidence of melanoma after surgery.
- Have not received systemic anti-cancer therapy (drugs that circulate throughout the body, such as immunotherapy) for this condition in the last 5 years.
Note: Additional study criteria apply.
What happens during the study?
- Screening Period: Approximately 28 days
- Study Treatment Period: 12 months
- Follow-up Period: Up to 4 years
You may be in the study for up to 5 years.
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, medical history, and medicines that you take. You will also have a checkup and some tests.
Treatment
If you qualify for the study, you will visit the clinic about every 3 weeks for 12 months to receive study treatment and to have tests to check on your health. You will also have surveillance scans about every 12 weeks to help ensure you remain free from melanoma.
Follow-Up
After your final dose of study treatment, you will have visits with tests to check on your health and monitor your tumor status. The frequency of these visits will depend on your tumor status.
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 A2 study drugs (higher dose)
Group B2 study drugs (lower dose)
Group CCommonly prescribed treatment(pembrolizumab + placebo)
The placebo looks like the study drugs but contains no active medicine. This gives researchers something to compare to the study drugs to better understand their effects. No patient in the study will receive placebo only. Everyone will receive an active anti-cancer treatment.
How are the study treatments given?
You will receive an infusion approximately every 3 weeks for 12 months.
An infusion means the study treatments are given slowly through a needle into a vein.
Each infusion will last about 30 minutes.
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 & Medication Review
Heart Activity
(if needed)
Blood Tests
Urine Test
(if needed)
Pregnancy Test
(if needed)
Questionnaires
Approximately every 12 weeks you will also have surveillance scans, such as:
Body Imaging
(CT and/or MRI)
Brain Imaging
(if needed)
You will not have all tests at every visit.
Throughout the study, you will also be checked for any side effects that may occur.
Find a Study Site
If you are interested in joining the HARMONY-Adjuvant Study, search the study sites below to see if there is a location near you. You can visit www.clinicaltrials.gov to find sites participating in the study.
