PV-10 for Melanoma

Phase-Based Progress Estimates
1
Effectiveness
1
Safety
MelanomaPV-10 - Drug
Eligibility
18+
All Sexes
What conditions do you have?
Select

Study Summary

This trial is testing PV-10, a new cancer treatment, in combination with an existing cancer treatment, pembrolizumab, to see if it is effective in treating metastatic melanoma.

Treatment Effectiveness

Effectiveness Progress

1 of 3

Study Objectives

0 Primary · 5 Secondary · Reporting Duration: Up to 24 months from initiation of study treatment

Month 24
Overall Survival (OS)
Week 4
Safety and tolerability of the combination regimen assessed by adverse events (AEs)
Month 24
Objective Response Rate (ORR)
Progression Free Survival (PFS)
Week 28
Change in immune biomarkers

Trial Safety

Safety Progress

1 of 3

Trial Design

3 Treatment Groups

Phase 2 (Arm 2)
1 of 3
Phase 1b
1 of 3
Phase 2 (Arm 1)
1 of 3

Active Control

Experimental Treatment

192 Total Participants · 3 Treatment Groups

Primary Treatment: PV-10 · No Placebo Group · Phase 1 & 2

Phase 1bExperimental Group · 2 Interventions: PV-10, Pembrolizumab · Intervention Types: Drug, Drug
Phase 2 (Arm 1)Experimental Group · 2 Interventions: PV-10, Pembrolizumab · Intervention Types: Drug, Drug
Phase 2 (Arm 2)
Drug
ActiveComparator Group · 1 Intervention: Pembrolizumab · Intervention Types: Drug
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Rose bengal
FDA approved
Pembrolizumab
FDA approved

Trial Logistics

Trial Timeline

Screening: ~3 weeks
Treatment: Varies
Reporting: up to 24 months from initiation of study treatment

Who is running the clinical trial?

Provectus Biopharmaceuticals, Inc.Lead Sponsor
4 Previous Clinical Trials
110 Total Patients Enrolled
2 Trials studying Melanoma
98 Patients Enrolled for Melanoma
Eric Wachter, Ph.D.Study DirectorProvectus Pharmaceuticals, Inc.
6 Previous Clinical Trials
196 Total Patients Enrolled
2 Trials studying Melanoma
40 Patients Enrolled for Melanoma

Eligibility Criteria

Age 18+ · All Participants · 10 Total Inclusion Criteria

Mark “Yes” if the following statements are true for you:
The condition is present when the absolute neutrophil count (ANC) is greater than 1.
You have stage IV or stage III melanoma.
You have a performance status of 0 or 1.
You have at least one cutaneous, subcutaneous, or soft tissue lesion, or at least one nodal or visceral lesion.
You are a male or female aged 18 years or older.
You have a histologically or cytologically confirmed diagnosis of melanoma.
You have at least 1 Injectable lesion that is suitable for injection with PV-10.