What is the Harmony Head to Head Study?
Thank you for your interest in the Harmony Head to Head Study. This is a clinical study testing the effects of 2 study drugs to see if, when used together, they can safely treat adults with advanced melanoma skin cancer.
The effects of the study drugs will be compared to another combination treatment that is already used to treat melanoma in some countries.
Please note that this clinical study will use investigational drug products, the safety and efficacy of which have not been fully evaluated by regulatory authorities and which have not received marketing authorization in any country.
Who can participate?
To be considered for this study, you must:
- Be 18 years of age or older.
- Have melanoma that cannot be fully removed with surgery (unresectable, Stage 3) or that has spread to distant parts of the body (metastatic, Stage 4).
- Have NOT received prior systemic therapy for unresectable or metastatic melanoma.
What happens
during the study?
If you qualify for the study, you will have several visits to receive the study treatment and to have health checks and tests.
Informed Consent
Before any study procedures can begin, you will first need to give your consent, or permission, to find the study site by reading and signing the Informed Consent Form.
Screening
(up to 28 days)
To determine whether you qualify for the study, the study team will ask questions about your health, medical history, and the medicines you take. You will also have a checkup and some tests.
Study Treatment
If you qualify for the study, you will be placed by chance into a study treatment group to receive:
- 2 study drugs (given together) every 3 weeks
or
- The approved combination treatment every 4 weeks
The study treatment is given as an infusion, which means it is given slowly through a needle into a vein in your arm.
How long you receive the study treatment will depend on how well it is working and on any side effects you may experience. This decision will be up to you and your doctor.
You will also have visits with tests to check on your health and to see how your cancer is responding to treatment.
Follow-up
Once you have stopped receiving the study treatment, you will have additional visits to check on your health. The number of visits you have will depend on how your cancer responded to the study treatment.
- If you have decided to stop study treatment and your cancer did not grow while taking the study treatment, you will have visits every 90 days until your cancer grows or you start another cancer treatment.
- If your cancer grows while taking the study treatment, you will have 1 visit approximately 90 days after your final dose and phone calls with the study team every 3 months.
What kind of health checks and tests can I expect?
During the study, you will have visits to the study site for health checks and tests. You will not have every test at each visit.
Physical exam
Vital signs
Weight
Heart activity
(ECG)
Blood tests
Urine test
Pregnancy test
(if needed)
Tumor sample
(if needed)
Body imaging
(CT/MRI scan)
Brain imaging
Photos of skin tumor site
(if needed)
CT = computed tomography; ECG = electrocardiogram; MRI = magnetic resonance imaging.
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 Head to Head 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.