A Phase II Study of Cemiplimab Plus Ziv-Aflibercept for Subjects With Metastatic Uveal Melanoma
H. Lee Moffitt Cancer Center and Research Institute
Summary
The goal of this clinical research study is to find out if Cemiplimab plus Ziv-Aflibercept is safe and effective in treating your condition of metastatic (spread to other parts of your body) uveal melanoma. This research study will test the study drugs to see if the combination of Cemiplimab plus Ziv-Aflibercept can make tumors shrink or stop growing.
Eligibility
- Age range
- 18+ years
- Sex
- All
- Healthy volunteers
- No
Inclusion Criteria: * Provision of signed and dated informed consent form. * Male or female, aged \>/= 18 years old. * Life expectancy of greater than 3 months in the opinion of the investigator. * Must be willing and able to provide informed consent signed by study patient or legally acceptable representative, as specified by health authorities and institutional guidelines. * Patients must have metastatic uveal melanoma, either initial presentation or recurrent, that is histologically diagnosed. * Patients with histologically or cytologically confirmed metastatic melanoma or cutaneous, mucos…
Interventions
- DrugZIV-Aflibercept
Ziv-Aflibercept is an investigational or experimental anti-cancer agent inactivates vascular endothelial growth factor (VEGF) from functioning and scientific experiments have shown that when VEGF is prevented from working, new blood vessels don't form in tumors and these tumors do not grow. In addition, VEGF has been shown to have a negative effect on the immune response and blocking it may help the immune response against cancer.
- DrugCemiplimab
Cemiplimab is a human monoclonal anti-PD-1 antibody that works by blocking the programmed death-1 (PD-1), a cell receptor on immune cells that is involved in preventing immune cells from destroying other cells. Blocking the receptor is expected to help immune cells attack cancer cells.
Locations (4)
- The Angeles Clinic and Research InstituteLos Angeles, California
- Moffitt Cancer CenterTampa, Florida
- University of Chicago Medical CenterChicago, Illinois
- Northwell Health Center for Advanced MedicineNew Hyde Park, New York