What is the Harmony Perioperative CSCC Study?
Thank you for your interest in the Harmony Perioperative CSCC Study. This is a clinical study being done to learn more about a study drug when given separately or in combination with another study drug, before and after surgery in adults with advanced CSCC. Researchers will compare the effects of the single study drug with the study drug combination.
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 advanced CSCC (Stage 3 or 4) for which surgery is recommended.
- Have NOT received systemic anti-cancer therapy (drugs that spread throughout the body, such as immunotherapy) within the last 3 years.
- Have NOT received radiation for CSCC.
What happensduring the study?
This study has 2 parts. Part 1 occurs before surgery and Part 2 occurs after surgery.
You may be in the study for a little over 4 years. While you are in the study, you will have several visits to receive study treatment and have health checks and tests.
Informed Consent
Before any study procedures can begin, you will first need to give your consent, or permission, to join the study by reading and signing the Informed Consent Form.
Screening (up to 28 days; 1 visit)
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 (Part 1: up to 12 weeks; Part 2: up to 1 year)
If you qualify for the study, you will be placed by chance into a study treatment group.
In Part 1 (before surgery), you will be placed in a group to receive:
- 1 study drug
or
- The study drug combination
In Part 2 (after surgery), you will be placed into another group depending on whether your cancer is completely gone.
- If your cancer is completely gone, you will either continue the study treatment you received in Part 1 or receive no study treatment and be watched very closely (observation).
- If your cancer is not completely gone, you will continue the study treatment you received in Part 1.
The study treatment is given as an infusion, which means it is given slowly through a vein in your arm every 3 or 6 weeks.
You will also have visits with tests to check on your health and to see how your cancer is responding to treatment.
Follow-up (up to 3 years)
After completing the study treatment, you will have visits to check on your health and to see if your cancer comes back.
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
Body imaging
(CT/MRI scan)
Digital photos
Questionnaires
Medicine review
Health status
CT = computed tomography; ECG = electrocardiogram; MRI = magnetic resonance imaging.
Throughout the study, you will also be checked for any side effects that may happen.
Interested in joining?
If you are interested in joining the study, click below to see if you may qualify.
Find a Study Site
Below is a list of sites that are participating in this study. Please review to see if there’s a location near you.