NCT02275416

Safety of UV1 Vaccination in Combination With Ipilimumab in Patients With Unresectable or Metastatic Malignant Melanoma

• Status: Completed
• Phase: Phase 1 / Phase 2
• Study type: Interventional
• Enrollment: 12 (actual)
• Sponsor: Ultimovacs ASA · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

This study, with 20 patients participating, will examine the safety and tolerability for the ipilimumab/UV1 combination in patients with unresectable or metastatic malignant melanoma.

Detailed description

This is a phase I/IIa, national, open label, single arm, interventional study examining safety and tolerability for the ipilimumab/UV1 combination in patients with unresectable or metastatic malignant melanoma. Patients that have signed the informed consent form will be asked to take part in the study. All patients will receive ipilimumab together with the UV1 vaccine and rranulocyte-macrophage colony-stimulating factor (GM-CSF). Ipilimumab will be given every 3rd week for a total of 4 doses. The UV1 vaccine and GM-CSF will be given before and between treatments of ipilimumab. The maximum number of UV1/GM-CSF will be 10 doses. Immunoresponders maybe followed up every third months for 5 years after the first UV1 treatment. Follow-up is onging.

Conditions

• Malignant Melanoma

Interventions

Type	Name	Description
DRUG	Ipilimumab
BIOLOGICAL	UV1 vaccine
BIOLOGICAL	GM-CSF

Timeline

• Start date: 2015-02-02
• Primary completion: 2016-10-06
• Completion: 2020-11-03
• First posted: 2014-10-27
• Last updated: 2024-12-16

Locations

1 site across 1 country: Norway