Regen 3767-2208

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:
  • Are diagnosed with stage III or stage IV melanoma (stage IV patients must have 3 or fewer resectable lesions)
  • Are candidates for full resection of their disease
For more information about who can join this study, please contact the study team at gi-oncology-cru@dm.duke.edu or 919-668-1861.

What is Involved?

Description

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:
  • Get a higher dose of the study drugs (1600 mg fianlimab, 350 mg cemiplimab) every 3 weeks; OR
  • Get a lower dose of the study drugs (400 mg fianlimab, 350 mg cemiplimab) every 3 weeks; OR
  • Get a 200 mg dose of pembrolizumab with a placebo (inactive substance) every 3 weeks
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 Anti-PD1 Alone in Patients with Resectable Stage III and IV Melanoma

Principal Investigator

April
Salama

Protocol Number

PRO00114411

NCT ID

NCT06190951

Phase

II

Enrollment Status

Open to Enrollment
ClinicalTrials.gov