Purpose of this Study
We are doing this study to find out if the experimental combination of the drugs finalimab and cemiplimab (the study drugs) is a safe and effective option for people with high-risk melanoma. We want to see how well the study drugs work compared to treatment with pembrolizumab.
Who Can Participate?
Eligibility
Adults ages 18+ who:<ul>
<li>Are diagnosed with stage III or stage IV melanoma (stage IV patients must have 3 or fewer resectable lesions)</li>
<li>Are candidates for full resection of their disease</li></ul>
For more information about who can join this study, please contact the study team at <a href= "mailto: gi-oncology-cru@dm.duke.edu">gi-oncology-cru@dm.duke.edu</a> or 919-668-1861.
<li>Are diagnosed with stage III or stage IV melanoma (stage IV patients must have 3 or fewer resectable lesions)</li>
<li>Are candidates for full resection of their disease</li></ul>
For more information about who can join this study, please contact the study team at <a href= "mailto: gi-oncology-cru@dm.duke.edu">gi-oncology-cru@dm.duke.edu</a> or 919-668-1861.
What is Involved?
If you choose to join the study and are eligible, you will get a random assignment (fair, equal chance) to 1 or 3 groups. Your assignment will be to:<ul>
<li>Get a higher dose of the study drugs (1600 mg fianlimab, 350 mg cemiplimab) every 3 weeks; OR</li>
<li>Get a lower dose of the study drugs (400 mg fianlimab, 350 mg cemiplimab) every 3 weeks; OR</li>
<li>Get a 200 mg dose of pembrolizumab with a placebo (inactive substance) every 3 weeks</li></ul>
You will receive 3 doses of drugs in your study regimen before surgery (neoadjuvant therapy) and 15 doses after (adjuvant treatment).
This study is double-blinded. This means that neither you nor the study doctor or the study staff will know whether you are being given study drugs (fianlimab plus cemiplimab) or pembrolizumab with placebo. There is no risk that you will receive only a placebo. In order to keep the study blinded, everyone will be given the same number of infusions once every 3 weeks.
<li>Get a higher dose of the study drugs (1600 mg fianlimab, 350 mg cemiplimab) every 3 weeks; OR</li>
<li>Get a lower dose of the study drugs (400 mg fianlimab, 350 mg cemiplimab) every 3 weeks; OR</li>
<li>Get a 200 mg dose of pembrolizumab with a placebo (inactive substance) every 3 weeks</li></ul>
You will receive 3 doses of drugs in your study regimen before surgery (neoadjuvant therapy) and 15 doses after (adjuvant treatment).
This study is double-blinded. This means that neither you nor the study doctor or the study staff will know whether you are being given study drugs (fianlimab plus cemiplimab) or pembrolizumab with placebo. There is no risk that you will receive only a placebo. In order to keep the study blinded, everyone will be given the same number of infusions once every 3 weeks.
Study Details
Full Title
A Phase 2 Peri-operative Trial of Fianlimab and Cemiplimab Compared
with Pembrolizumab in Patients with Resectable Stage III and IV Melanoma
with Pembrolizumab in Patients with Resectable Stage III and IV Melanoma
Principal Investigator
April
Salama
Protocol Number
PRO00114411
NCT ID
NCT03002376
Phase
II
Enrollment Status
Pending Open to Enrollment