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About
UV1 is a therapeutic cancer vaccine that has been explored in prostate, lung cancer, in combination with ipilimumab in malignant melanoma and in combination with pembrolizumab in metastatic melanoma. This study will explore the Efficacy and Safety of UV1 administered with GM-CSF in combination with nivolumab and ipilimumab.
Full 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.
Enrollment
Sex
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Volunteers
Inclusion criteria
Male or female patients at least 18 years of age at the time of signing the ICF.
Histologically confirmed diagnosis of unresectable stage IIIB D, or unresectable stage IV malignant melanoma.
Eligible for combination treatment with nivolumab and ipilimumab.
An ECOG performance status of 0 or 1.
Adequate organ function as indicated by the following laboratory values:
Hematological
Male patients who are sexually active with a female of childbearing potential must agree to use an adequate method of contraception.
Women of childbearing potential (WOCBP) must have a negative urine or serum/plasma pregnancy test.
WOCBP must use adequate contraception.
Exclusion criteria
Primary purpose
Allocation
Interventional model
Masking
156 participants in 2 patient groups
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Central trial contact
Øivind Foss
Data sourced from clinicaltrials.gov
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