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PV-10 + Pembrolizumab for Melanoma
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.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowTimeline
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Trial Design
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Who is running the clinical trial?
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- 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.
- Group 1: Phase 2 (Arm 2)
- Group 2: Phase 1b
- Group 3: Phase 2 (Arm 1)
- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
- 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.
Frequently Asked Questions
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."
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."
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."
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."
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."
For what purpose is PV-10 typically used?
"PV-10 is a medication used to treat malignant neoplasms, unresectable melanoma, and microsatellite instability high."
Who else is applying?
What state do they live in?
What site did they apply to?
What portion of applicants met pre-screening criteria?
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