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UV1 Vaccination Plus Nivolumab and Ipilimumab in Treatment of Melanoma

NCT04382664 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 156

Last updated 2025-01-14

Study results available
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Summary

This is a randomized, open label study to investigate efficacy and safety of UV1 vaccination in combination with nivolumab and ipilimumab as first line treatment of adult patients with histologically confirmed unresectable metastatic melanoma.

Conditions

  • Malignant Melanoma

Interventions

BIOLOGICAL

UV1

UV1 vaccine (300 μg) will be injected intradermally.

BIOLOGICAL

Sargramostim

Sargramostim (75 μg) is used as a vaccine adjuvant.

BIOLOGICAL

Ipilimumab

Ipilimumab is dosed according to label.

BIOLOGICAL

Nivolumab

Nivolumab is dosed according to label.

Sponsors & Collaborators

  • Ultimovacs ASA

    lead INDUSTRY

Principal Investigators

  • Karl Lewis · University of Colorado Hospital - Anschutz Cancer Pavilion

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2020-05-27
Primary Completion
2024-01-11
Completion
2024-04-10
FDA Drug
Yes

Countries

  • United States
  • Belgium
  • Norway
  • United Kingdom

Study Locations

More Related Trials

Entities

Drugs

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04382664 on ClinicalTrials.gov