Phase 2 Study of Cemiplimab Combined with Ziv-Aflibercept to Treat Adults with Metastatic Uveal Melanoma

What this Trial Is About

Researchers are studying metastatic uveal melanoma, a type of cancer that has spread to other parts of the body. This clinical research aims to evaluate if combining the drugs Cemiplimab and Ziv-Aflibercept is safe and effective in shrinking tumors or stopping their growth in people with this condition. The study is a phase II trial sponsored by the H. Lee Moffitt Cancer Center and Research Institute, focusing on advanced melanoma cases that may have progressed despite prior therapies. Participants will receive Cemiplimab at a dose of 350 mg intravenously every three weeks, alongside Ziv-Aflibercept at 4 mgkg intravenously every two weeks. The treatment cycles last three weeks, with these drugs given in combination throughout the study period. This investigational approach tests how blocking certain immune and blood vessel pathways may affect tumor control in metastatic uveal melanoma. During the study, participants will be closely monitored with regular assessments to measure tumor response using standardized criteria. Researchers will track outcomes such as the objective response rate, progression-free survival, and overall survival over a period of five years. Safety evaluations and ongoing health status checks will be part of the follow-up to understand the impact of the treatment combination on patients disease and wellbeing.

Study of Cemiplimab Plus Ziv-Aflibercept for Subjects With Metastatic Uveal Melanoma