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Checkpoint Inhibitor
UV1 + Nivolumab + Ipilimumab for Melanoma
Phase 2
Waitlist Available
Led By Karl Lewis
Research Sponsored by Ultimovacs ASA
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Adequate organ function as indicated by specific laboratory values
Male patients who are sexually active with a female of childbearing potential must agree to use an adequate method of contraception
Timeline
Screening 3 weeks
Treatment Varies
Follow Up time from randomization to death from any cause /follow-up until 70 pfs, estimated up to 51 months
Awards & highlights
Study Summary
This trial will explore whether the cancer vaccine UV1, when given with the drugs nivolumab and ipilimumab, is effective and safe.
Who is the study for?
This trial is for adults with a specific stage of melanoma (unresectable stage IIIB D or IV) who have not had prior treatments for this advanced cancer. They must be healthy enough based on lab tests, agree to use contraception if they can have children, and cannot be pregnant or breastfeeding. People with infections needing treatment, immune deficiencies, severe allergies to certain drugs, HIV/hepatitis B/C, recent heart issues, other cancers within 2 years (unless cured), brain metastases or eye melanoma are excluded.Check my eligibility
What is being tested?
The study is testing the effectiveness and safety of UV1 vaccine combined with GM-CSF (Sargramostim), Nivolumab and Ipilimumab in treating unresectable malignant melanoma. Patients will receive this combination therapy to see how well it works compared to current standard treatments.See study design
What are the potential side effects?
Possible side effects include reactions at the injection site from the vaccine and GM-CSF; fatigue; skin rash; diarrhea; liver inflammation from Nivolumab and Ipilimumab; potential autoimmune problems where the body's immune system attacks its own cells.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
My organ functions are within normal ranges according to recent tests.
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I agree to use contraception if I'm sexually active with a woman who can have children.
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I am eligible for treatment with nivolumab and ipilimumab.
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I am a woman who can have children and have a negative pregnancy test.
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I am fully active or can carry out light work.
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My melanoma cannot be removed by surgery and is at an advanced stage.
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I am 18 years old or older.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ time from randomization to death from any cause /follow-up until 70 pfs, estimated up to 51 months
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~time from randomization to death from any cause /follow-up until 70 pfs, estimated up to 51 months
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
PFS per Response Evaluation Criteria in Solid Tumors (RECIST) 1.1
Secondary outcome measures
DOR per RECIST 1.1
Evaluation of Adverse events, vital signs, laboratory assessments and ECOG performance status
ORR per RECIST 1.1
+1 moreOther outcome measures
Immunological mechanisms
Trial Design
2Treatment groups
Experimental Treatment
Active Control
Group I: UV1 vaccination + nivolumab and ipilimumabExperimental Treatment4 Interventions
UV1 vaccination + nivolumab and ipilimumab
Group II: Nivolumab and ipilimumabActive Control2 Interventions
nivolumab and ipilimumab
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Ipilimumab
2014
Completed Phase 3
~2620
Sargramostim
2008
Completed Phase 4
~710
Nivolumab
2014
Completed Phase 3
~4750
Find a Location
Who is running the clinical trial?
Ultimovacs ASALead Sponsor
7 Previous Clinical Trials
287 Total Patients Enrolled
2 Trials studying Melanoma
42 Patients Enrolled for Melanoma
Karl LewisPrincipal InvestigatorUniversity of Colorado Hospital - Anschutz Cancer Pavilion
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- 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.
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.
Research Study Groups:
This trial has the following groups:- Group 1: UV1 vaccination + nivolumab and ipilimumab
- Group 2: Nivolumab and ipilimumab
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
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."
Answered by AI
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."
Answered by AI
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."
Answered by AI
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."
Answered by AI
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