NCT04382664

UV1 Vaccination Plus Nivolumab and Ipilimumab in Treatment of Melanoma

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)

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 156 (actual)
• Sponsor: Ultimovacs ASA · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Detailed description

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. Patients in the experimental arm will receive 8 UV1 vaccinations over 4 cycles of nivolumab and ipilimumab. Patients in the control arm will receive 4 cycles of nivolumab and ipilimumab. Patients in both arms will start maintenance therapy 6 weeks after the last dose of induction therapy, nivolumab at a dose of 480 mg every 4 weeks. All patients will be followed up until death or until the end of the study. To support the Extended Exploratory Cohort of the study, an additional 20 patients at selected sites will be enrolled in a single arm UV1 cohort for collection of additional biological material. These patients are in addition to the 156 randomized patients in the main part of the study and will not be included in the main analysis of the study.

Conditions

• Malignant Melanoma

Interventions

Type	Name	Description
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.

Timeline

• Start date: 2020-05-27
• Primary completion: 2024-01-11
• Completion: 2024-04-10
• First posted: 2020-05-11
• Last updated: 2025-01-14
• Results posted: 2025-01-14

Locations

37 sites across 4 countries: United States, Belgium, Norway, United Kingdom

Regulatory

• FDA-regulated drug study