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Opdivo

Phase 1

Uveal Melanoma | Small molecule | Oncology |NovoCure Limited|Last Updated: Aug 15, 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
UNCONTROLLEDBiomarker
Total Trials1
Total Enrollment10
FDA Designations
No designations recorded
Clinical Trials (1)
NCT IDTitlePhaseStatusEnrollmentVelocityDesignStartCompletionLast UpdatedSitesCountries
NCT05004025Single Arm Trial of Tumor-Treating Fields in Combination With Nivolumab and Ipilimumab in Metastatic Uveal MelanomaPHASE1 COMPLETED 10Feb 28, 2022Jul 23, 2025Aug 15, 20252 United States
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Study Endpoints
Primary Endpoints
Overall Response Rate
from the initiation of study treatment and through study completion, up to 1 year

evaluate the overall response rate of patients with mUM treated with TTF in combination with nivolumab and ipilimumab.

Overall Safety
From the initiation of study treatment and through study completion, up to 1 year

Evaluate the safety of TTF in combination with nivolumab and ipilimumab (Number of patients who developed grade 3 treatment-related adverse events as assessed by CTCAE v5)

Secondary Endpoints
Overall Survival Rate
From initiation of study treatment until date of death from any cause, up to 100 months
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Study Design & Arms
AllocationNA
MaskingNONE
ModelSINGLE_GROUP
PurposeTREATMENT
Treatment Arms
ArmTypeDescription
TTF Plus ChemotherapyEXPERIMENTALNovacure Optune with Opdivo and Yervoy
Interventions
NameTypeDescription
Novocure OptuneDEVICENovacure Optune with Opdivo and Yervoy
OpdivoDRUGNovacure Optune with Opdivo and Yervoy
YervoyDRUGNovacure Optune with Opdivo and Yervoy
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Eligibility Criteria
Age Range18 Years — 100 Years
SexALL
Healthy VolunteersNo
Study Sites2

Inclusion Criteria: 1. Patient has histologically or cytologically confirmed metastatic uveal melanoma with predominant liver involvement 2. Age 18 years or older and willing and able to provide informed consent 3. WOCBP must have a negative serum pregnancy test documented with 72 hours of first ad...

Countries:United States
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