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Recruiting Phase 2 NCT06121180

NCT06121180 Study of Cemiplimab Plus Ziv-Aflibercept for Subjects With Metastatic Uveal Melanoma

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Clinical Trial Summary
NCT ID NCT06121180
Status Recruiting
Phase Phase 2
Sponsor H. Lee Moffitt Cancer Center and Research Institute
Condition Metastatic Uveal Melanoma
Study Type INTERVENTIONAL
Enrollment 32 participants
Start Date 2024-11-04
Primary Completion 2030-10-31

Trial Parameters

Condition Metastatic Uveal Melanoma
Sponsor H. Lee Moffitt Cancer Center and Research Institute
Study Type INTERVENTIONAL
Phase Phase 2
Enrollment 32
Sex ALL
Min Age 18 Years
Max Age N/A
Start Date 2024-11-04
Completion 2030-10-31
Interventions
ZIV-AfliberceptCemiplimab

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Brief 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 Criteria

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, mucosal or unknown primary origin are also eligible. This includes AJCC stage IV or advanced/inoperable stage III. This also includes patients with a history of lower stage melanoma and subsequent recurrent metastatic disease that is either locally/regionally advanced/inoperable disease or distant metastases. These patients must have previously received anti-PD1 immunotherapy (nivolumab or pembrolizumab

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