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Trial Summary

This is a Phase 2 study to assess the efficacy, safety, and tolerability of V937 administered both intratumorally (ITu) and intravenously (IV) as combination therapy with pembrolizumab (MK-3475) versus pembrolizumab alone in anti-programmed cell death ligand 1 (anti-PD-L1)-treatment-naive participants with advanced/metastatic melanoma.

Acronym:

V937-011-02

ACTRN/NCT /ethics:

NCT04152863

Scientific title:

A Phase 2, Randomized Clinical Study of Intravenous or Intratumoral Administration of V937 in Combination With Pembrolizumab (MK-3475) Versus Pembrolizumab Alone in Participants With Advanced/Metastatic Melanoma

Sponsor / Cooperative group:

Merck Sharp & Dohme Corp.

Trial & Patient Characteristics

Cancer TypeMelanoma & other skin
Trial TypeTreatment
PhasePhase II
Age Range18 years and older
SexAll
Tumour Stream -
Cancer StageMetastatic or Widespread
Anticipated Start Date2020-16-05
Anticipated End Date2024-07-01

Participating Hospitals

HospitalThe Queen Elizabeth Hospital
Clinical Trial CoordinatorPamela Cooper
Emailpamela.cooper@sa.gov.au
Phone08 8222 6410
Principal InvestigatorDr Rachel Roberts-Thomson
Recruitment StatusRecruiting