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

NCT02288897 · Status: TERMINATED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 20

Last updated 2022-01-19

Study results available
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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.

Conditions

Interventions

DRUG

PV-10 (10% rose bengal disodium)

DRUG

Dacarbazine, temozolomide or talimogene laherparepvec

Sponsors & Collaborators

  • Provectus Biopharmaceuticals, Inc.

    lead INDUSTRY

Principal Investigators

  • Eric Wachter, Ph.D. · Provectus Biopharmaceuticals, Inc.

  • Sanjiv Agarwala, M.D. · St Luke's University Hospital and Health Network

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2015-04-30
Primary Completion
2019-04-30
Completion
2019-09-30

Countries

  • United States
  • France
  • Germany
  • Italy
  • Mexico

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02288897 on ClinicalTrials.gov