Melanoma Clinical Trial

Efficacy, Safety, and Tolerability of Gebasaxturev (V937) Administered Intravenously or Intratumorally With Pembrolizumab (MK-3475) Versus Pembrolizumab Alone in Participants With Advanced/Metastatic Melanoma (V937-011)

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. The primary hypothesis of the study is that V937 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.

View Eligibility Criteria

Eligibility Criteria

Inclusion Criteria:

Has histologically or cytologically confirmed diagnosis of advanced/metastatic melanoma.
Has Stage III or Stage IV melanoma.
Must be naive to anti-PD-L1 treatment, talimogene laherparepvec (TVEC) and other oncolytic viruses.

Has 2 lesions as defined below:

At least 1 cutaneous or subcutaneous lesion that is amenable to IT injection and biopsy and measurable per RECIST 1.1
At least 1 distant and/or discrete noninjected lesion that is amenable to biopsy and measurable per RECIST 1.1
Has a performance status of 0 or 1 on the Eastern Cooperative Oncology Group (ECOG) Performance Scale
Demonstrates adequate organ function
Male participants refrain from donating sperm during the intervention period and for at least 120 days after the last dose of study intervention PLUS are either abstinent from heterosexual intercourse OR agree to use approved contraception during that period
Female participants are not pregnant or breastfeeding and are not a woman of childbearing potential (WOCBP) OR are a WOCBP that agrees to use contraception during the treatment and for at least 120 days after the last dose of study intervention
Has measurable disease per RECIST 1.1
Is able to provide newly obtained core or excisional biopsy of a tumor lesion not previously irradiated

Human Immunodeficiency Virus (HIV)-infected participants must have well controlled HIV on anti-retroviral therapy (ART), defined as:

Must have Cluster of Differentiation 4 (CD4)+ T-cell count >350 cells/mm^3 at time of screening
Must have achieved and maintained virologic suppression
Must have been on a stable regimen, without changes in drugs or dose modification, for at least 4 weeks prior to study entry
The combination ART regimen must not contain any antiretroviral medication other than abacavir, dolutegravir, emtricitabine, lamivudine, raltegravir, rilpivirine, or tenofovir

Exclusion Criteria:

Has had chemotherapy, definitive radiation, or biological cancer therapy or an investigational agent or investigational device within 4 weeks prior to the first dose of study intervention or has not recovered to Common Terminology Criteria for Adverse Events (CTCAE) Grade 1 or better from any AEs that were due to cancer therapeutics administered more than 4 weeks earlier
Has ocular melanoma
Has radiographic evidence of major blood vessel infiltration
Has clinically significant hemoptysis or tumor bleeding within 2 weeks prior to the first dose of study drug
Has an active autoimmune disease that has required systemic treatment in the past 2 years except vitiligo or resolved childhood asthma/atopy
HIV-infected participants with a history of Kaposi's sarcoma and/or Multicentric Castleman's Disease
Has a known psychiatric or substance abuse disorder that would interfere with the participant's ability to cooperate with the study requirements
Has undergone allogeneic hematopoietic stem cell transplantation within the last 5 years
Has not fully recovered from major surgery without significant detectable infection
Active cardiovascular disease (<6 months prior to enrollment), myocardial infarction (<6 unstable angina, congestive heart failure or serious cardiac arrhythmia requiring medication
Has received prior therapy with an anti-PD-1, anti-PD-L1, or anti PD-L2 agent or other agents such as cytotoxic T-lymphocyte-associated protein-4 (CTLA-4), OX-40, Cluster of Differentiation 137 (CD137)
Has received a live vaccine within 30 days prior to the first dose of study drug
Is currently participating in or has participated in a study of an investigational agent or has used an investigational device within 4 weeks prior to the first dose of study intervention
Has a diagnosis of immunodeficiency or is receiving chronic systemic steroid therapy in excess of replacement doses or any other form of immunosuppressive therapy within 7 days prior the first dose of study drug
Has a known additional malignancy that is progressing or has required active treatment within the past 2 years
Has known active central nervous system (CNS) metastases and/or carcinomatous meningitis
Has hypersensitivity to pembrolizumab and/or any of its excipients
Has hypersensitivity to gebasaxturev or any of its excipients
Has a history of (non-infectious) pneumonitis that required steroids or has current pneumonitis
Has an active infection requiring systemic therapy
Has a known history of Hepatitis B or known active Hepatitis C virus infection
Has a history or current evidence of any condition, therapy, or laboratory abnormality that might confound the results of the study, interfere with the participant's participation for the full duration of the study, or is not in the best interest of the participant to participate, in the opinion of the treating investigator
Has had an allogenic tissue/solid organ transplant

Study is for people with:

Melanoma

Phase:

Phase 2

Estimated Enrollment:

135

Study ID:

NCT04152863

Recruitment Status:

Active, not recruiting

Sponsor:

Merck Sharp & Dohme LLC

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There are 30 Locations for this study

See Locations Near You

Henry Ford Hospital ( Site 0008)
Detroit Michigan, 48202, United States
Rutgers Cancer Institute of New Jersey ( Site 0002)
New Brunswick New Jersey, 08903, United States
Providence Portland Medical Center [Portland, OR] ( Site 0005)
Portland Oregon, 97213, United States
Northwest Medical Specialties, PLLC ( Site 0006)
Tacoma Washington, 98405, United States
The Queen Elizabeth Hospital ( Site 0143)
Woodville South Australia, 5011, Australia
Alfred Health ( Site 0142)
Melbourne Victoria, 3004, Australia
Fiona Stanley Hospital ( Site 0141)
Murdoch Western Australia, 6150, Australia
FALP-UIDO ( Site 2062)
Santiago Region M. De Santiago, 69009, Chile
Bradfordhill-Clinical Area ( Site 2061)
Santiago Region M. De Santiago, 84203, Chile
Centre Georges Francois Leclerc ( Site 2025)
Dijon Cote-d Or, 21079, France
CHU de Grenoble Hopital Nord ( Site 2027)
La Tronche Isere, 38700, France
Universitaetsklinikum Tuebingen-Hautklinik ( Site 2001)
Tübingen Baden-Wurttemberg, 72076, Germany
Universitaetsklinikum Regensburg ( Site 2007)
Regensburg Bayern, 93053, Germany
Universitaetsklinikum Leipzig AOeR ( Site 2005)
Leipzig Sachsen, 04103, Germany
Rambam Health Care Campus-Oncology Division ( Site 0040)
Haifa , 31096, Israel
Hadassah Ein Kerem Medical Center ( Site 0042)
Jerusalem , 91120, Israel
Chaim Sheba Medical Center ( Site 0041)
Ramat Gan , 52620, Israel
Istituto Europeo di Oncologia ( Site 2040)
Milano , 20141, Italy
Policlinico Le Scotte - A.O. Senese ( Site 2039)
Siena , 53100, Italy
Seoul National University Hospital ( Site 1992)
Seoul , 03080, Korea, Republic of
Severance Hospital Yonsei University Health System ( Site 1993)
Seoul , 03722, Korea, Republic of
Oslo Universitetssykehus Radiumhospitalet ( Site 0060)
Oslo , 0424, Norway
WITS Clinical Research CMJAH Clinical Trial Site ( Site 0101)
Johannesburg Gauteng, 2193, South Africa
Clinical Research Unit - University of Pretoria ( Site 0102)
Pretoria Gauteng, 0002, South Africa
Wilgers Oncology Centre ( Site 0103)
Pretoria Gauteng, 0081, South Africa
Little Company of Mary Hospital ( Site 0100)
Pretoria Gauteng, 0181, South Africa
Cape Town Oncology Trials Pty Ltd ( Site 0104)
Cape Town Western Cape, 7570, South Africa
Onkologikoa - Instituto Oncologico de San Sebastian ( Site 0088)
San Sebastian Gipuzkoa, 20014, Spain
Clinica Universitaria de Navarra. ( Site 0082)
Pamplona Navarra, 31008, Spain
Hospital Clinico Universitario de Valencia ( Site 0090)
Valencia Valenciana, Comunitat, 46010, Spain

How clear is this clinincal trial information?

Study is for people with:

Melanoma

Phase:

Phase 2

Estimated Enrollment:

135

Study ID:

NCT04152863

Recruitment Status:

Active, not recruiting

Sponsor:


Merck Sharp & Dohme LLC

How clear is this clinincal trial information?

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