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Corticosteroid

Cancer Vaccine + Pembrolizumab for Melanoma

Phase 1
Waitlist Available
Research Sponsored by Ultimovacs ASA
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Adequate blood, liver and kidney function
Consent to undergo tumor biopsies during the study
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to 2 years
Awards & highlights

Study Summary

This trial will explore whether a cancer vaccine is safe and effective when combined with other treatments for melanoma.

Who is the study for?
This trial is for melanoma patients who haven't been treated yet but can receive pembrolizumab, except if they've had BRAF and MEK inhibitors. They must be willing to have tumor biopsies, not have other cancers unless in remission for 5+ years, and should not be pregnant or planning to become parents soon. People with hypersensitivity to GM-CSF, eye melanoma, lung inflammation history or heart disease cannot join.Check my eligibility
What is being tested?
The study tests the UV1 vaccine combined with GM-CSF in patients also getting pembrolizumab for unresectable or metastatic melanoma. It aims to assess how safe and effective this combination is when used as a first-time treatment.See study design
What are the potential side effects?
Potential side effects may include typical vaccine reactions like soreness at injection site, fever, fatigue; immune-related issues due to pembrolizumab such as skin rash or thyroid problems; plus any adverse effects from GM-CSF like bone pain or weakness.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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My blood, liver, and kidney functions are all within normal ranges.
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I agree to have tumor biopsies during the study.
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My melanoma is at stage IIIB, IIIC, or IV.
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I have not been treated before, except with BRAF and MEK inhibitors, and can receive pembrolizumab.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to 2 years
This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 2 years for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Number of patients with treatment-related adverse events
Secondary outcome measures
The length of time from the start of treatment that patients are still alive.
Tumor response

Trial Design

1Treatment groups
Experimental Treatment
Group I: Experimental TreatmentExperimental Treatment2 Interventions
UV1/GM-CSF
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
GM-CSF
2014
Completed Phase 4
~1340

Find a Location

Who is running the clinical trial?

Ultimovacs ASALead Sponsor
7 Previous Clinical Trials
413 Total Patients Enrolled
2 Trials studying Melanoma
168 Patients Enrolled for Melanoma

Media Library

Pembrolizumab (Corticosteroid) Clinical Trial Eligibility Overview. Trial Name: NCT03538314 — Phase 1
Melanoma Research Study Groups: Experimental Treatment
Melanoma Clinical Trial 2023: Pembrolizumab Highlights & Side Effects. Trial Name: NCT03538314 — Phase 1
Pembrolizumab (Corticosteroid) 2023 Treatment Timeline for Medical Study. Trial Name: NCT03538314 — Phase 1

Frequently Asked Questions

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

Are there any vacancies for prospective participants in this clinical study?

"Unfortunately, this clinical trial is not currently accepting patients. The data posted to clinicaltrials.gov shows that it was initially listed on July 9th 2018 and last edited on November 16th 2022; however, there are 753 other trials seeking participants at the moment."

Answered by AI

How many sites are utilized for the management of this trial?

"Four medical sites are responsible for conducting this trial including University of Iowa Carver College of Medicine in Iowa City, St. Luke's University Health Network in Easton, and John Wayne Cancer Center in Santa Monica; plus an additional 4 locations."

Answered by AI

To what extent does UV1 pose a risk to humans?

"Due to the limited safety and efficacy data available, our team assigned UV1 a score of one on the risk scale."

Answered by AI
Recent research and studies
clinicaltrials.govStudy
UV1 Vaccine With Pembrolizumab for Patients With Unresectable or Metastatic Melanoma
2018. "UV1 Vaccine With Pembrolizumab for Patients With Unresectable or Metastatic Melanoma". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT03538314.
~4 spots leftby Apr 2025
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