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

Sponsor
Ultimovacs ASA
Study ID
NCT02275416
Phase
PHASE1/PHASE2
Status
Completed

Conditions

Eligibility Criteria

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

Interventions

  • Ipilimumab — DRUG
  • UV1 vaccine — BIOLOGICAL
  • GM-CSF — BIOLOGICAL

Study Details

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.

Key Dates

First listed
Oct 27, 2014
Start date
Feb 2, 2015
Status verified
Dec 2024
Primary completion
Oct 6, 2016
Completion
Nov 3, 2020

Study Design

Enrollment
12 participants (actual)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

Arms

  • Experimental: Ipilimumab & UV1 vaccine & GM-CSF
    Ipilimumab (3 mg/kg) every 3rd week for a total of 4 doses. GM-CSF (75 μg) followed by UV1 vaccine (300 μg) will be injected intradermally in the lower abdomen before and between treatments of ipilimumab and thereafter every 4th week up to 28 weeks, and thereafter at week 36 and 48.

Primary Outcome Measure

Safety and tolerability profile. Frequency/ severity of adverse and serious adverse events. Biochemistry and hematology results, vital signs and ECOG [ Time Frame: Up to 53 weeks ]

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