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.
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.
Pregnancy or lactation.
Treatment with another investigational drug or other systemic intervention for uveal melanoma within 4 weeks of initiation of study drugs. Patients must not have radiotherapy within the preceding 4 weeks.
Patients must be at least 4 weeks from major surgery and have fully recovered from any effects of surgery and be free of significant detectable infection.
Patients must not have autoimmune disorders or conditions of immunosuppression that require current ongoing treatment with systemic corticosteroids (or other systemic immunosuppressants), including oral steroids (i.e., prednisone, dexamethasone) or continuous use of topical steroid creams or ointments or ophthalmologic steroids. A history of occasional (but not continuous) use of steroid inhalers is allowed.
Single group
ZIV-Aflibercept
DrugZiv-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.
Cemiplimab
DrugCemiplimab 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.
objective response rate (ORR)
objective response rate as defined by Complete response (CR) plus partial response (PR) as assessed by RECIST criteria version 1.1.
Progression free survival (PFS)
Progression free survival (PFS) will be measured from the initial date of treatment to the date of documented progression, or the date of death (in the absence of progression).
Overall survival (OS)
Overall survival (OS) will be measured from the initial date of treatment to the recorded date of death.
Click on the lead sponsor to view all of their trials.
H. Lee Moffitt Cancer Center and Research Institute
Lead sponsor
Genzyme, a Sanofi Company
Collaborator
Regeneron Pharmaceuticals
Collaborator
