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V504

Phase 2

Cervical Cancer | Monoclonal antibody | Oncology |Merck & Company, Inc.|Last Updated: Jun 8, 2015

Success Probability

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Market & Valuation

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Trial Design

RandomizedDouble-BlindPLACEBO_CONTROLLED
Total Trials1
Total Enrollment620

FDA Designations

No designations recorded

Clinical trial landscape

V504 · 1 trial · 5 indications

Phase 2 1
NCT00551187A Study to Evaluate Tolerability and Immunogenicity of V504 Administered Concomitantly With GARDASIL (V504-001)(COMPLETED)Cervical Cancer
COMPLETED620 Analytics
PHASE2COMPLETED
A Study to Evaluate Tolerability and Immunogenicity of V504 Administered Concomitantly With GARDASIL (V504-001)(COMPLETED)
Cervical CancerUnlock trial analytics

Study Endpoints

Primary Endpoints

Geometric mean titers (GMTs) to HPV types contained in the administered vaccines
4 weeks post dose 3

Secondary Endpoints

Seroconversion percentages to HPV types contained in the administered vaccines
4 weeks post dose 3
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Study Design & Arms

AllocationRANDOMIZED
MaskingDOUBLE
ModelPARALLEL
PurposePREVENTION

Treatment Arms

ArmTypeDescription
1EXPERIMENTALV504 + Quadrivalent Human Papillomavirus (Types 6, 11, 16, 18) Recombinant Vaccine
2PLACEBO_COMPARATORPlacebo + Quadrivalent Human Papillomavirus (Types 6, 11, 16, 18) Recombinant Vaccine

Interventions

NameTypeDescription
V504BIOLOGICALV504 0.5 ml injection in 3 dose regimen for 6 month treatment period.
Comparator: Quadrivalent Human Papillomavirus (Types 6, 11, 16, 18) Recombinant VaccineBIOLOGICALQuadrivalent Human Papillomavirus (Types 6, 11, 16, 18) Recombinant Vaccine 0.5 ml injection in 3 dose regimen for 6 month treatment period.
Comparator: Placebo (unspecified)BIOLOGICALV504 Placebo in 3 dose regimen for 6 month treatment period.
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Eligibility Criteria

Age Range16 Years to 26 Years
SexFEMALE
Healthy VolunteersYes

Inclusion Criteria: * Females between 16- to 26-years-old * Has never had Pap testing or has only had normal Pap test results. * Lifetime history of 0 to 4 sexual partners Exclusion Criteria: * History of an abnormal cervical biopsy result * History of a positive test for HPV; History of external...

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Competitive Landscape -Cervical Cancer 65 trials

Frequently asked questions about V504

What is V504 used for?

V504 is an investigational monoclonal antibody being studied for use in cervical cancer. It is also being evaluated in the context of human papillomavirus infection, genital warts, vulvar cancer, and vaginal cancer. The drug is currently in Phase 2 clinical development.

Who makes V504?

V504 is being developed by Merck & Company, Inc., which trades under the ticker MRK. The company is conducting clinical trials to evaluate the drug's safety and efficacy in oncology and infectious disease settings.

What phase is V504 in?

V504 is in Phase 2 clinical development. It is an investigational drug and has not been approved by regulatory authorities. The drug is being studied in a completed Phase 2 trial that evaluated its tolerability and immunogenicity.

What clinical trials is V504 in?

V504 has one completed clinical trial, identified as NCT00551187. This Phase 2 study evaluated the tolerability and immunogenicity of V504 when administered concomitantly with GARDASIL. The trial enrolled 620 female participants aged 16 years and older.

Is V504 the same as GARDASIL?

No, V504 is not the same as GARDASIL. V504 is an investigational monoclonal antibody, while GARDASIL is a vaccine. In the clinical trial NCT00551187, V504 was administered concomitantly with GARDASIL to evaluate their combined use.