PV-10 vs Chemotherapy or Oncolytic Viral Therapy for Treatment of Locally Advanced Cutaneous Melanoma
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ClinicalTrials.gov Identifier: NCT02288897 |
Recruitment Status :
Terminated
(Inadequate rate of enrollment)
First Posted : November 11, 2014
Last Update Posted : October 2, 2019
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Tracking Information | |||||||
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First Submitted Date ICMJE | November 4, 2014 | ||||||
First Posted Date ICMJE | November 11, 2014 | ||||||
Last Update Posted Date | October 2, 2019 | ||||||
Actual Study Start Date ICMJE | April 2015 | ||||||
Actual Primary Completion Date | April 2019 (Final data collection date for primary outcome measure) | ||||||
Current Primary Outcome Measures ICMJE |
Progression-free survival (PFS) [ Time Frame: Assessed every 12 weeks up to 18 months ] | ||||||
Original Primary Outcome Measures ICMJE | Same as current | ||||||
Change History | |||||||
Current Secondary Outcome Measures ICMJE |
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Original Secondary Outcome Measures ICMJE |
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Current Other Pre-specified Outcome Measures |
Change in domain scores from baseline using the patient reported Skindex-16 instrument [ Time Frame: Assessed 12 weeks after Day 1 ] | ||||||
Original Other Pre-specified Outcome Measures | Not Provided | ||||||
Descriptive Information | |||||||
Brief Title ICMJE | PV-10 vs Chemotherapy or Oncolytic Viral Therapy for Treatment of Locally Advanced Cutaneous Melanoma | ||||||
Official Title ICMJE | PV-10 Intralesional Injection vs Systemic Chemotherapy or Oncolytic Viral Therapy for Treatment of Locally Advanced Cutaneous Melanoma | ||||||
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. |
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Study Type ICMJE | Interventional | ||||||
Study Phase ICMJE | Phase 3 | ||||||
Study Design ICMJE | Allocation: Randomized Intervention Model: Parallel Assignment Masking: Single (Outcomes Assessor) Masking Description: Blinded review by independent review committee (IRC) for primary and key secondary endpoints. Primary Purpose: Treatment
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Condition ICMJE | Cutaneous Melanoma | ||||||
Intervention ICMJE |
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Study Arms ICMJE |
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Publications * | Not Provided | ||||||
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. |
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Recruitment Information | |||||||
Recruitment Status ICMJE | Terminated | ||||||
Actual Enrollment ICMJE |
32 | ||||||
Original Estimated Enrollment ICMJE |
225 | ||||||
Actual Study Completion Date ICMJE | September 2019 | ||||||
Actual Primary Completion Date | April 2019 (Final data collection date for primary outcome measure) | ||||||
Eligibility Criteria ICMJE | Inclusion Criteria:
Exclusion Criteria:
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Sex/Gender ICMJE |
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Ages ICMJE | 18 Years and older (Adult, Older Adult) | ||||||
Accepts Healthy Volunteers ICMJE | No | ||||||
Contacts ICMJE | Contact information is only displayed when the study is recruiting subjects | ||||||
Listed Location Countries ICMJE | France, Germany, Italy, Mexico, United States | ||||||
Removed Location Countries | Australia | ||||||
Administrative Information | |||||||
NCT Number ICMJE | NCT02288897 | ||||||
Other Study ID Numbers ICMJE | PV-10-MM-31 | ||||||
Has Data Monitoring Committee | Yes | ||||||
U.S. FDA-regulated Product | Not Provided | ||||||
IPD Sharing Statement ICMJE | Not Provided | ||||||
Responsible Party | Provectus Pharmaceuticals ( Provectus Biopharmaceuticals, Inc. ) | ||||||
Study Sponsor ICMJE | Provectus Biopharmaceuticals, Inc. | ||||||
Collaborators ICMJE | Not Provided | ||||||
Investigators ICMJE |
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PRS Account | Provectus Pharmaceuticals | ||||||
Verification Date | September 2019 | ||||||
ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |