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ZIV-Aflibercept

Phase 2

Metastatic Uveal Melanoma | Small molecule | Oncology |Sanofi|Last Updated: Dec 4, 2025

Success Probability
Approval Probability 71%
TA Base Rate26%
Adjusted LOA41%
ML RiskLOW_RISK
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Market & Valuation
rNPV $3.2B
Market Size $9.4B
Revenue Basis $1.6B
Competitors 6
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Trial Design
UNCONTROLLEDDMCBiomarker
Total Trials1
Total Enrollment32
FDA Designations
No designations recorded
Clinical Trials (1)
NCT IDTitlePhaseStatusEnrollmentVelocityDesignStartCompletionLast UpdatedSitesCountries
NCT06121180Study of Cemiplimab Plus Ziv-Aflibercept for Subjects With Metastatic Uveal MelanomaPHASE2 RECRUITING 32Nov 4, 2024Oct 31, 2030Dec 4, 20254 United States
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Study Endpoints
Primary Endpoints
objective response rate (ORR)
5 years

objective response rate as defined by Complete response (CR) plus partial response (PR) as assessed by RECIST criteria version 1.1.

Secondary Endpoints
Progression free survival (PFS)
5 years
Overall survival (OS)
5 years
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Study Design & Arms
AllocationNA
MaskingNONE
ModelSINGLE_GROUP
PurposeTREATMENT
Treatment Arms
ArmTypeDescription
Cemiplimab + Ziv-AfliberceptEXPERIMENTALOne cycle consists of 3 weeks during which: Cemiplimab 350 mg administered IV every 3 weeks given with Ziv-Aflibercept 4 mg/kg administered IV every 2 weeks.
Interventions
NameTypeDescription
ZIV-AfliberceptDRUGZiv-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.
CemiplimabDRUGCemiplimab 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.
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Eligibility Criteria
Age Range18 Years — N/A
SexALL
Healthy VolunteersNo
Study Sites4

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 re...

Countries:United States
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Recent Changes (Last 90 Days)
LOWMay 26, 2026NCT06121180primaryCompletionDate: changed
LOWMay 24, 2026NCT06121180studyFirstPostDate: changed