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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
Stage IV or Stage III (unresectable, in-transit or satellite) melanoma
At least 1 Injectable Lesion suitable for injection with PV-10
Must not have
Prior treatment with PV-10 or any checkpoint inhibitor without meeting specific criteria
Subjects unable to comprehend and give informed consent
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to 24 months from initiation of study treatment
Awards & highlights
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 belowSelect...
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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My melanoma diagnosis was confirmed through lab tests.
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I am fully active or can carry out light work.
Exclusion Criteria
You may be eligible for the trial if you check “No” for criteria below:Select...
I have not been treated with PV-10 or checkpoint inhibitors without meeting certain conditions.
Select...
I am unable to understand and agree to the study's details.
Select...
I have melanoma that has spread to my brain and it's either untreated or still active.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ up to 24 months from initiation of study treatment
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to 24 months from initiation of study treatment
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 moreTrial 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 2
~2010
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
Eligibility Criteria:
This trial includes the following eligibility criteria:- I do not have severe autoimmune diseases, uncontrolled illnesses, or recent other cancers.You need to have at least one tumor that can be accurately measured using a ruler, CT scan, or MRI.Your blood counts, kidney function, liver function, and thyroid function are within certain healthy levels.I have not been treated with PV-10 or checkpoint inhibitors without meeting certain conditions.I haven't had cancer treatment or a cancer vaccine recently.I am not pregnant, breastfeeding, and I use effective birth control.I am unable to understand and agree to the study's details.My melanoma is at an advanced stage and cannot be surgically removed.I have at least one tumor that can be injected.I am 18 years old or older.My melanoma diagnosis was confirmed through lab tests.I am fully active or can carry out light work.I have melanoma that has spread to my brain and it's either untreated or still active.
Research Study Groups:
This trial has the following groups:- Group 1: Phase 2 (Arm 2)
- Group 2: Phase 1b
- Group 3: Phase 2 (Arm 1)
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
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