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Trovax

Phase 3

Clear Cell Renal Carcinoma | Monoclonal antibody | Oncology |Sanofi|Last Updated: Oct 19, 2020

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
RandomizedDouble-BlindPLACEBO_CONTROLLEDDMCBiomarker
Total Trials1
Total Enrollment733
FDA Designations
No designations recorded
Clinical Trials (1)
NCT IDTitlePhaseStatusEnrollmentVelocityDesignStartCompletionLast UpdatedSitesCountries
NCT00397345TroVax Renal Immunotherapy Survival TrialPHASE3 COMPLETED 733Sep 1, 2006Dec 1, 2009Oct 19, 2020152 United States, France +8
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Study Endpoints
Primary Endpoints
overall survival
18 months
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Study Design & Arms
AllocationRANDOMIZED
MaskingTRIPLE
ModelPARALLEL
PurposeTREATMENT
Treatment Arms
ArmTypeDescription
TrovaxEXPERIMENTAL -
PlaceboPLACEBO_COMPARATOR -
Interventions
NameTypeDescription
TrovaxBIOLOGICAL1ml IM injection 2-8 weeks apart.
PlaceboBIOLOGICALPlacebo
Standard of care therapyBIOLOGICALsubcutaneous low dose IL-2, interferon-α or sunitinib
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Eligibility Criteria
Age Range18 Years — N/A
SexALL
Healthy VolunteersNo
Study Sites152

Inclusion Criteria: * Signed informed consent. The patient must be competent to give written informed consent and comply with the protocol requirements. * Locally advanced or metastatic, histologically proven clear cell renal carcinoma. * Primary tumour surgically removed (some residual advanced pr...

Countries:United StatesFranceGermanyIsraelPolandRomaniaRussiaSpainUkraineUnited Kingdom
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