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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
This is a Phase 2 study to assess the efficacy, safety, and tolerability of gebasaxturev 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. The primary hypothesis of the study is that gebasaxturev administered either ITu or IV in combination with pembrolizumab results in a superior objective response rate (ORR) per Response Evaluation Criteria In Solid Tumors Version 1.1 (RECIST 1.1) based on blinded independent central review (BICR), compared to pembrolizumab alone. This study will be terminated once all participants finish treatment with V937. Participants eligible to continue to receive pembrolizumab will be transferred to MK-3475-587 study.
Age
18 - No limit years
Sex
ALL
Healthy Volunteers
No
Henry Ford Hospital ( Site 0008)
Detroit, Michigan, United States
Rutgers Cancer Institute of New Jersey ( Site 0002)
New Brunswick, New Jersey, United States
Providence Portland Medical Center [Portland, OR] ( Site 0005)
Portland, Oregon, United States
Northwest Medical Specialties, PLLC ( Site 0006)
Tacoma, Washington, United States
The Queen Elizabeth Hospital ( Site 0143)
Woodville, South Australia, Australia
Alfred Health ( Site 0142)
Melbourne, Victoria, Australia
Fiona Stanley Hospital ( Site 0141)
Murdoch, Western Australia, Australia
FALP-UIDO ( Site 2062)
Santiago, Region M. de Santiago, Chile
Bradfordhill-Clinical Area ( Site 2061)
Santiago, Region M. de Santiago, Chile
Centre Georges Francois Leclerc ( Site 2025)
Dijon, Cote-d Or, France
Start Date
June 5, 2020
Primary Completion Date
July 12, 2023
Completion Date
July 12, 2023
Last Updated
August 6, 2024
85
ACTUAL participants
Gebasaxturev IV
BIOLOGICAL
Gebasaxturev ITu
BIOLOGICAL
Pembrolizumab
DRUG
Lead Sponsor
Merck Sharp & Dohme LLC
Data Source & Attribution
This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.
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