At a glance
ClinicalIndex Comparison RecordPhase 2Completed· 156 enrolled
Drug / intervention
UV1 +3 morebiological
Likely dose
UV1 300 μgfrom record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.
Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
Efficacy and Safety of UV1 Vaccination in Combination With Nivolumab and Ipilimumab as First Line Treatment of Patients With Unresectable or Metastatic Melanoma (INITIUM Study)
In Brief
A Phase 2 clinical trial evaluating UV1, Sargramostim, and 2 other interventions for Malignant Melanoma. Completed, enrolled 156 participants across 37 sites in 4 countries.
Detailed 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.
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsMalignant Melanoma
CountriesBelgium, Norway, United Kingdom, United States
Collaborators--
Timeline
Phase 2CompletedFinished
202120222023202420252026
First PostedMay 2020
Enrollment StartMay 2020
Primary CompletionJan 2024
Study CompletionApr 2024
TodayJul 2026
First PostedMay 11, 2020
Enrollment StartMay 27, 2020
Primary CompletionJan 11, 2024
Study CompletionApr 10, 2024
TodayJul 2, 2026
Enrollment to primary: 3.6 yearsPosted 6.1 years ago
Interventions
UV1biological
UV1 vaccine (300 μg) will be injected intradermally.
Sargramostimbiological
Sargramostim (75 μg) is used as a vaccine adjuvant.
Ipilimumabbiological
Ipilimumab is dosed according to label.
Nivolumabbiological
Nivolumab is dosed according to label.