Spots Global Cancer Trial Database for PV-10 vs Chemotherapy or Oncolytic Viral Therapy for Treatment of Locally Advanced Cutaneous Melanoma
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Trial Identification
Brief Title: PV-10 vs Chemotherapy or Oncolytic Viral Therapy for Treatment of Locally Advanced Cutaneous Melanoma
Official Title: PV-10 Intralesional Injection vs Systemic Chemotherapy or Oncolytic Viral Therapy for Treatment of Locally Advanced Cutaneous Melanoma
Study ID: NCT02288897
Conditions
Study Description
Brief Summary: This is an international multicenter, open-label, randomized controlled trial (RCT) of single-agent intralesional PV-10 versus systemic chemotherapy or intralesional oncolytic viral therapy to assess treatment of locally advanced cutaneous melanoma in patients who (1) are not candidates for targeted therapy and (2) are not candidates for an immune checkpoint inhibitor. Subjects in the comparator arm will receive the Investigator's choice of dacarbazine (DTIC), temozolomide (TMZ) or intralesional talimogene laherparepvec as determined by Investigator preference and standard of care in the Investigator's country or region. Effectiveness will be assessed by comparison of progression-free survival (PFS) between all intent-to-treat (ITT) subjects in the two study treatment arms.
Detailed Description: Subjects will be randomized using a 2:1 treatment allocation (i.e. two-thirds of the subjects will receive PV-10). Subjects in the comparator arm who have completed at least 1 cycle of study treatment and who meet the study protocol definition of disease progression but do not have evidence of visceral metastases will be eligible to enter the crossover portion of the study and receive PV-10. Subjects crossing over must meet all study inclusion and exclusion criteria for clinical laboratories, thyroid function, concurrent or intercurrent illness and pregnancy at the time of crossover. Assessment of progression will be performed by an Independent Review Committee (IRC) based on Response Evaluation Criteria in Solid Tumors (RECIST) ver. 1.1 criteria. Events signaling progression include increase in size and/or number of lesions, distant or nodal disease progression, or death. All secondary endpoints involving disease response and progression will be based on the IRC determination. An interim assessment of efficacy and safety will be performed by the IRC when 50% of the events required for the primary endpoint have occurred.
Eligibility
Minimum Age: 18 Years
Eligible Ages: ADULT, OLDER_ADULT
Sex: ALL
Healthy Volunteers: No
Locations
Sharp Memorial Hospital - Clinical Oncology Research, San Diego, California, United States
Mount Sinai Comprehensive Cancer Center, Miami Beach, Florida, United States
Moffitt Cancer Center and Research Institute, Tampa, Florida, United States
Washington University School of Medicine - Dermatology, Saint Louis, Missouri, United States
Dartmouth-Hitchcock Medical Center, Lebanon, New Hampshire, United States
Atlantic Health System, Morristown, New Jersey, United States
Wake Forest Baptist Health, Winston-Salem, North Carolina, United States
Oklahoma Cancer Specialists and Research Institute, Tulsa, Oklahoma, United States
St Luke's University Hospital and Health Network, Easton, Pennsylvania, United States
Penn State Hershey Cancer Institute, Hershey, Pennsylvania, United States
M.D. Anderson Cancer Center, Houston, Texas, United States
Huntsman Cancer Institute, Salt Lake City, Utah, United States
Unité Cancéro-Dermatologie, Hôtel-Dieu CHU Nantes, Nantes, , France
Institut Claudius Regaud, IUCT ONCOPOLE, Toulouse, , France
Klinik für Dermatologie, Venerologie und Allergologie Charite Universitätsmedizin Berlin, Berlin, , Germany
Klinik für Dermatologie Universitätsklinikum Essen Studienzentrum, Essen, , Germany
Klinik für Dermatologie, Venerologie und Allergologie Universitätsklinikum Schleswig-Holstein Hautkrebszentrum, Kiel, , Germany
Hautklinik Klinikum der Johannes Gutenberg Universität Hautkrebszentrum, Mainz, , Germany
IRCCS Instituto Nazionale Tumori "Fondazione Giovanni Pascale", Napoli, , Italy
Istituto Dermopatico dell'Immacolata (IDI IRCCS), Rome, , Italy
Azienda Sanitaria Azienda Ospedaliera Universitaria Senese, Siena, , Italy
Centro de Estudios y Prevención del Cancer A.C., Juchitán de Zaragoza, Oaxaca, Mexico
Neurociencias Estudios Clínicos S.C., Culiacán, Sinaloa, Mexico
Contact Details
Name: Eric Wachter, Ph.D.
Affiliation: Provectus Biopharmaceuticals, Inc.
Role: STUDY_DIRECTOR
Name: Sanjiv Agarwala, M.D.
Affiliation: St Luke's University Hospital and Health Network
Role: PRINCIPAL_INVESTIGATOR
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