PV-10 vs Chemotherapy or Oncolytic Viral Therapy for Treatment of Locally Advanced Cutaneous Melanoma

Stopped early · Phase 3

Conditions studied: Cutaneous Melanoma

In brief

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.

Key facts

Study ID

NCT02288897

Run by

Provectus Biopharmaceuticals, Inc.

People needed

20

Starts

2015-04-01

Expected to finish

2019-09-01

Last updated by the study team

2022-01-19

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Age 18 years or older, male or female
• Histologically or cytologically confirmed melanoma
• Recurrent, satellite or in-transit locally advanced cutaneous or subcutaneous melanoma metastases (i.e., American Joint Committee on Cancer (AJCC) Stage IIIB, IIIC or Stage IV M1a with no active nodal metastases)
• At least 1 measurable Target Lesion that can be accurately measured by calipers or computed tomography (CT) consisting of:
• at least one cutaneous lesion (each lesion ≥ 10 mm in longest diameter or up to 5 lesions having a sum of longest diameters ≥ 10 mm); and/or
• at least one subcutaneous lesion (each lesion ≥ 10 mm in longest diameter by CT);
• where Target Lesions should be at least 10 mm from any other lesion
• No lesion > 50 mm in longest diameter; and no more than 50 lesions
• Calculated required PV-10 dose ≤ 15 mL (based on total tumor burden)
• Performance Status: Eastern Cooperative Oncology Group (ECOG) 0-2
• Not a candidate for treatment with an immune checkpoint inhibitor (e.g., failed or did not tolerate prior therapy, or due to co-morbidities, pre-existing autoimmune disease, drug unavailability or standard of care)
• Not a candidate for targeted therapy with BRAF or combined BRAF/MEK inhibitors (e.g., failed or did not tolerate prior therapy, BRAF V600 wild-type or due to drug unavailability or standard of care)
• Clinical Laboratories:
• Absolute neutrophil count (ANC) ≥ 1.5 x 10\^9/L and platelet count ≥100 x 10\^9/L
• Creatinine ≤ 3 times the upper limit of normal (ULN)
• Estimated creatinine clearance (CrCl) or estimated glomerular filtration rate (eGFR) ≥ 30 mL/min/1.73 m2
• Total bilirubin ≤ 3 times the upper limit of normal (ULN)
• Aspartate transaminase (AST), alanine transaminase (ALT) and alkaline phosphatase (ALP) ≤ 5 times the upper limit of normal (ULN)
• Lactate dehydrogenase (LDH) ≤ 2 times the upper limit of normal (ULN).
• Thyroid function abnormality ≤ Grade 2
• Candidate for at least one comparator drug:
• Subjects must be candidates for at least one of the designated comparator drugs

You may not qualify if…

• Presence or history of visceral melanoma metastasis
• Presence of active nodal metastases (e.g., radiologic or clinical evidence of current nodal disease)
• Presence of more than 50 melanoma lesions
• Radiation therapy to any Study Lesion within 6 weeks of initial study treatment.
• Chemotherapy or other systemic cancer therapy within 4 weeks of initial study treatment (6 weeks for nitrosoureas or mitomycin), or regional chemotherapy (limb infusion or perfusion) within 12 weeks of initial study treatment
• Immunotherapy for cancer within 4 weeks of initial study treatment
• Local treatment (e.g., surgery, cryotherapy, laser ablation) to any Study Lesion within 4 weeks of initial study treatment
• Anti-tumor vaccine therapy within 6 weeks of initial study treatment.
• Investigational agents within 4 weeks of initial study treatment.
• Concurrent or Intercurrent Illness:
• Impaired wound healing or other extremity complications due to diabetes mellitus in subjects whose Study Lesions are located in an extremity
• Severe peripheral vascular disease in subjects whose Study Lesions are located in an extremity
• Significant concurrent or intercurrent illness, psychiatric disorders, or alcohol or chemical dependence that would, in the opinion of the Investigator, compromise the subject's safety or compliance or interfere with interpretation of study results.
• Uncontrolled thyroid disease or cystic fibrosis
• Clinically significant acute or unstable cardiovascular, cerebrovascular (stroke), renal, gastrointestinal, pulmonary, immunological, endocrine, or central nervous system disorders
• Pregnancy:
• Female subjects who are pregnant or lactating
• Female subjects who have positive serum pregnancy test taken within 14 days of study treatment
• Female subjects of child-bearing potential who are unwilling to use highly effective contraception (e.g., combined (estrogen and progestogen containing) or progestogen-only hormonal contraceptives, intrauterine devices, bilateral tubal ligation, vasectomized partner, sexual abstinence or equivalent measures) for the duration of study treatment
• Contraindication for all comparators:
• Subjects with contraindications to all of the designated comparator drugs

Where it is running

• 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 — St 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" — Naples, 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

Full record on ClinicalTrials.gov

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