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UV1 + Nivolumab + Ipilimumab for Melanoma
Study Summary
This trial will explore whether the cancer vaccine UV1, when given with the drugs nivolumab and ipilimumab, is effective and safe.
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 have not received a live vaccine in the last 30 days.My organ functions are within normal ranges according to recent tests.I agree to use contraception if I'm sexually active with a woman who can have children.I have or had hepatitis B or currently have hepatitis C.I had cancer other than melanoma, was treated successfully, and have been in remission for over 2 years.I am eligible for treatment with nivolumab and ipilimumab.I am a woman who can have children and have a negative pregnancy test.I haven't taken high doses of steroids or any immunosuppressants in the last week.I have had treatment for advanced melanoma that couldn't be removed by surgery.I have cancer that has spread to my brain or its coverings.I am fully active or can carry out light work.My melanoma cannot be removed by surgery and is at an advanced stage.I have been diagnosed with HIV.I have been diagnosed with eye melanoma.I have a history of lung inflammation not caused by an infection.I have severe heart failure or had a heart attack in the last 6 months.I am currently being treated for an infection.I have been diagnosed with an immune system disorder.I am 18 years old or older.
- 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.
- Group 1: UV1 vaccination + nivolumab and ipilimumab
- Group 2: Nivolumab and ipilimumab
Frequently Asked Questions
Will there be any harmful side effects from UV1 exposure during treatment?
"While there is some evidence collected thus far to support UV1's safety, its efficacy has not been explored yet. Therefore, it received a score of 2."
Where are potential participants able to take part in this research?
"To limit participant burden, the 21 sites for this study are located close to major cities including Dallas, Rochester and San Marcos. It is recommended that you select the trial site that is closest to your location."
What are the primary conditions that doctors treat with UV1?
"More often than not, UV1 is used as a cancer treatment. However, it has also been shown to improve outcomes for patients with allogenic bone marrow transplantation therapy, unresectable melanoma, and squamous cell carcinoma."
Can you tell us about any other research done on UV1 in the past?
"There are 835 ongoing studies for UV1. Out of those, 91 are in the critical third phase. Most of the trials are based in Pittsburgh, although there are 44400 locations for this treatment."
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