UV1 Vaccination Plus Nivolumab and Ipilimumab in Treatment of Melanoma

Part of paid clinical trials in Phoenix, Arizona.

Sponsor
Ultimovacs ASA
Study ID
NCT04382664
Phase
PHASE2
Status
Completed

Conditions

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • UV1 — BIOLOGICAL
    UV1 vaccine (300 μg) will be injected intradermally.
  • Sargramostim — BIOLOGICAL
    Sargramostim (75 μg) is used as a vaccine adjuvant.
  • Ipilimumab — BIOLOGICAL
    Ipilimumab is dosed according to label.
  • Nivolumab — BIOLOGICAL
    Nivolumab is dosed according to label.

Study Details

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.

Key Dates

Start date
May 27, 2020
Status verified
Jan 2025
Primary completion
Jan 11, 2024
Completion
Apr 10, 2024

Study Design

Enrollment
156 participants (actual)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: UV1 vaccination + nivolumab and ipilimumab
    UV1 vaccination + nivolumab and ipilimumab
  • Active Comparator: Nivolumab and ipilimumab
    Nivolumab and ipilimumab

Primary Outcome Measure

PFS Per Response Evaluation Criteria in Solid Tumors (RECIST) 1.1 (by Blinded Independent Central Review (BICR) [ Time Frame: Time from randomization to progressive disease (PD) or death from any cause (approximately 44 months) ]

Locations (20)

FacilityCityStateZIPSite coordinators
Mayo Clinic HospitalPhoenixArizona85016-4880-
Highlands Oncology GroupFayettevilleArkansas72703-
University of California Irvine HealthOrangeCalifornia92868-
California Cancer Associates for Research & Excellence (CCARESan MarcosCalifornia92083-
Ridley-Tree Cancer CenterSanta BarbaraCalifornia93105-
Saint John's Health Center - John Wayne Cancer Institute (JWCI)Santa MonicaCalifornia90404-
University of Colorado Hospital - Anschutz Cancer PavilionAuroraColorado80045-
Holy Cross Medical GroupFort LauderdaleFlorida33308-
Sylvester Comprehensive Cancer CenterMiamiFlorida33136-1002-
Ocala Oncology CenterOcalaFlorida34474-
Rush University Medical Center - Rush University Cancer CenterChicagoIllinois60612-3841-
NorthShore University Research InstituteEvanstonIllinois60201-1718-
Oncology Specialists, S.C.Park RidgeIllinois60068-
Norton Cancer InstituteLouisvilleKentucky40241-
Nebraska Cancer Specialists- Midwest Cancer CenterPapillionNebraska68046-5706-
Icahn School of Medicine at Mount SinaiNew YorkNew York10029-
State University of New York (SUNY) Upstate Medical UniversityNew YorkNew York13210-
University of RochesterRochesterNew York14642-0001-
NorthShore University HealthSystemGreenvilleSouth Carolina29607-
Texas Oncology - Baylor Charles A. Sammons Cancer CenterDallasTexas75246-2092-

Find similar trials in Phoenix, AZ

By condition
Melanoma
By specialty
OncologySkin cancerDermatology
By research site
Mayo Clinic Hospital· Phoenix, AZHighlands Oncology Group· Fayetteville, ARUniversity of California Irvine Health· Orange, CACalifornia Cancer Associates for Research & Excellence (CCARE· San Marcos, CARidley-Tree Cancer Center· Santa Barbara, CASaint John's Health Center - John Wayne Cancer Institute (JWCI)· Santa Monica, CA

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