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ID-LV305

Phase 1

Melanoma - Currently Enrolling | Monoclonal antibody | Oncology |Merck & Company, Inc.|Last Updated: Mar 6, 2019

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 Enrollment47
FDA Designations
No designations recorded
Clinical Trials (1)
NCT IDTitlePhaseStatusEnrollmentVelocityDesignStartCompletionLast UpdatedSitesCountries
NCT02122861Phase 1 Study of Intradermal LV305 in Patients With Locally Advanced, Relapsed or Metastatic Cancer Expressing NY-ESO-1PHASE1 COMPLETED 47May 30, 2014Dec 15, 2018Mar 6, 20197 United States
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Study Endpoints
Primary Endpoints
Safety and tolerability
Up to 5 years after first study vaccine injection.

Incidence of Treatment-Emergent Adverse Events \[Safety and Tolerability\].

Secondary Endpoints
Immunogenicity
Approximately 12 weeks
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Study Design & Arms
AllocationNA
MaskingNONE
ModelSINGLE_GROUP
PurposeTREATMENT
Treatment Arms
ArmTypeDescription
ID-LV305EXPERIMENTALDose escalation and expansion cohort including treatment of melanoma
Interventions
NameTypeDescription
ID-LV305BIOLOGICALpembrolizumab
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Eligibility Criteria
Age Range18 Years — 100 Years
SexALL
Healthy VolunteersNo
Study Sites7

Inclusion Criteria: * Locally advanced, relapsed, and/or metastatic cancer with low or minimal tumor burden which may or may not be measurable; no tumor size criteria are used. * Tumor histology consistent with melanoma tumor specimen positive for NY-ESO-1 expression by IHC and/or RT-PCR. * b. In P...

Countries:United States
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