Study of Combo of Anti-LAG-3 & Anti-PD-1 Antibodies in Subjects with Advanced or Metastatic Melanoma - Clinical Trial
What is the Purpose of this Study?
We are doing this study to find the most effective, safe dose of a combination of the drugs fianlimab and ceminplimab. We want to know if this combination is an option for people with melanoma. We will compare how well this drug combination works to the usual treatment of relatlimab and nivolumab, which has the brand name Opdualag®.
Advanced or Metastatic Melanoma
Who Can Participate in the Study?
Adults ages 18+ who:
- Are diagnosed with stage III and stage IV (metastatic) melanoma
- Have disease that is unresectable (cannot be removed by surgery)
- Have not received any prior systemic therapy for unresectable or metastatic melanoma
For more information about who can join this study, please contact the study team at WakeCountyOncResearch@dm.duke.edu or 919-954-3085.
What is Involved?
Si decide unirse a este estudio, recibirá una asignación aleatoria (como lanzar una moneda al aire) para:
- Get a dose of fianlimab + cemiplimab every 3 weeks; OR
- Get a dose of Opdualag every 4 weeks
Both the study drug combination and Opdualag are given into a vein using a needle. This is called an intravenous (IV) infusion.
You will take your assigned study regimen for as long as the study doctor believes you are getting a benefit.
Se realizarán las siguientes pruebas y procedimientos a lo largo del estudio:
- Exámenes físicos
- Blood draws and urine samples
- Tumor biopsy
- Imaging (MRI/CT)
We will schedule you to come in for some return visits after you stop taking your study regimen. We will keep in touch with you to see how you are doing for up to 6 years after the final participant finishes the study.
Study Details
