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Checkpoint Inhibitor

PV-10 + Pembrolizumab for Melanoma

Phase 1 & 2
Waitlist Available
Research Sponsored by Provectus Biopharmaceuticals, Inc.
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Age 18 years or older, male or female
Histologically or cytologically confirmed diagnosis of melanoma
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to 24 months from initiation of study treatment
Awards & highlights
No Placebo-Only Group

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.

Who is the study for?
Adults with confirmed melanoma, either Stage IV or unresectable Stage III, who have at least one lesion that can be treated with an injection and are fit for pembrolizumab therapy. They must not be pregnant, should use effective contraception if of childbearing potential, and cannot have untreated brain metastases or a history of severe autoimmune disease.Check my eligibility
What is being tested?
The trial is testing PV-10 in combination with Pembrolizumab versus Pembrolizumab alone for treating metastatic melanoma. Initially, all participants will receive both treatments; later on, they'll be randomly assigned to continue this combo or just get Pembrolizumab.See study design
What are the potential side effects?
Potential side effects include reactions at the injection site from PV-10 and immune-related issues such as inflammation in organs due to Pembrolizumab. Other common side effects may involve fatigue, skin problems, digestive disturbances and changes in blood tests.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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I am 18 years old or older.
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My melanoma diagnosis was confirmed through lab tests.
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My melanoma is at an advanced stage and cannot be surgically removed.
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I have at least one tumor that can be injected.
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I am fully active or can carry out light work.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to 24 months from initiation of study treatment
This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 24 months from initiation of study treatment for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Secondary outcome measures
Change in immune biomarkers
Objective Response Rate (ORR)
Overall Survival (OS)
+2 more

Awards & Highlights

No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.

Trial Design

3Treatment groups
Experimental Treatment
Active Control
Group I: Phase 2 (Arm 1)Experimental Treatment2 Interventions
PV-10 (intralesional) and pembrolizumab (2 mg/kg every 3 weeks)
Group II: Phase 1bExperimental Treatment2 Interventions
PV-10 (intralesional) and pembrolizumab (2 mg/kg every 3 weeks)
Group III: Phase 2 (Arm 2)Active Control1 Intervention
Pembrolizumab (2 mg/kg every 3 weeks)
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
PV-10
2013
Completed Phase 1
~20
Pembrolizumab
2017
Completed Phase 3
~2050

Find a Location

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

Media Library

Pembrolizumab (Checkpoint Inhibitor) Clinical Trial Eligibility Overview. Trial Name: NCT02557321 — Phase 1 & 2
Melanoma Research Study Groups: Phase 2 (Arm 2), Phase 1b, Phase 2 (Arm 1)
Melanoma Clinical Trial 2023: Pembrolizumab Highlights & Side Effects. Trial Name: NCT02557321 — Phase 1 & 2
Pembrolizumab (Checkpoint Inhibitor) 2023 Treatment Timeline for Medical Study. Trial Name: NCT02557321 — Phase 1 & 2

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Could you please list how many places this research is happening?

"There are 4 primary locations for this clinical trial, situated in Lebanon, Houston and Portland. Additionally, there are 4 other recruitment sites. To limit travel burdens, it is advised that patients select the location closest to them."

Answered by AI

Are patients still being accepted into this research program?

"Yes, this information can be found on clinicaltrials.gov. The study was created on 10/1/2015 and the most recent update was 3/22/2022."

Answered by AI

Are there other PV-10 research projects in existence?

"The first trial for PV-10 took place in 2009 at Florida Hospital Tampa. There have been a total of 254 completed studies thus far. Out of the 1002 active clinical trials, many are based in Lebanon, New hampshire."

Answered by AI

Does this research study represent a new development in the medical field?

"Over 2999 cities and 63 countries have 1002 active studies for PV-10. The very first clinical trial happened in 2009, ran by Provectus Biopharmaceuticals, Inc.. Only 78 people participated in the Phase 1 drug approval stage of the study. In the 12 years since then, 254 more studies have been completed."

Answered by AI

How many people are participating in this clinical trial?

"In order to advance this study, we require 192 patients that meet the eligibility requirements. Currently, there are two locations where patients can participate in this trial: Dartmouth-Hitchcock Medical Center and MD Anderson Cancer Center."

Answered by AI

For what purpose is PV-10 typically used?

"PV-10 is a medication used to treat malignant neoplasms, unresectable melanoma, and microsatellite instability high."

Answered by AI

Who else is applying?

What state do they live in?
Texas
What site did they apply to?
MD Anderson Cancer Center
What portion of applicants met pre-screening criteria?
Met criteria
~5 spots leftby Feb 2025