Melanoma Clinical Trial
UV1 Vaccination Plus Nivolumab and Ipilimumab in Treatment of Melanoma
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.
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.
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:
Absolute neutrophil count ≥1,500/µL
Platelet count ≥100 x 103/µL
Hemoglobin ≥9 g/dL or ≥5.6 mmol/L Renal
Creatinine ≤1.5 x upper limit of normal (ULN) Hepatic
Total bilirubin ≤1.5 x ULN or direct bilirubin ≤ ULN for patients with total bilirubin levels >1.5 ULN
Aspartate aminotransferase/serum glutamic oxaloacetic transaminase and alanine aminotransferase/serum glutamic pyruvic transaminase ≤2.5 x ULN for patients without liver metastasis or ≤5 x ULN for patients with liver metastasis.
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.
Previous non melanoma malignancies unless curatively treated and complete remission was achieved at least 2 years prior to randomization. Patients with prior curatively treated basal or squamous cell carcinoma of the skin, carcinoma in situ of the cervix, or carcinoma in situ of the breast, or other in situ cancers are allowed irrespective of time passed since curative treatment. Patients with prior completely resected malignant melanoma are also allowed.
Known brain metastases or leptomeningeal metastases. If a patient experiences neurological symptoms indicative of brain metastases, a brain MRI should be performed.
Diagnosis of uveal or ocular melanoma.
Known history or any evidence of active, non-infectious pneumonitis.
History of New York Heart Association class 3-4 congestive heart failure or history of myocardial infarction within 6 months of starting induction therapy.
Active infection requiring systemic treatment.
Diagnosis of immunodeficiency.
Known history of severe hypersensitivity reactions to nivolumab, ipilimumab, sargramostim, or their excipients.
Known history of human immunodeficiency virus (HIV) (HIV 1/2 antibodies).
History of or active hepatitis B (hepatitis B surface antigen reactive) or active hepatitis C (hepatitis C virus antibody).
Women who are breastfeeding.
Prior systemic treatment for unresectable stage IIIB D or unresectable stage IV malignant melanoma.
Systemic corticosteroid treatment (doses exceeding 10 mg daily of prednisone or equivalent) or any other form of immunosuppressive treatment within 7 days prior to the first dose of induction therapy.
Receipt of a live vaccine within 30 days prior to start of induction therapy.
Receipt of any other investigational treatment within 4 weeks of the first dose of induction therapy.
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There are 37 Locations for this study
Phoenix Arizona, 85016, United States
Fayetteville Arkansas, 72703, United States
Orange California, 92868, United States
San Marcos California, 92083, United States
Santa Barbara California, 93105, United States
Santa Monica California, 90404, United States
Aurora Colorado, 80045, United States
Fort Lauderdale Florida, 33308, United States
Miami Florida, 33136, United States
Ocala Florida, 34474, United States
Chicago Illinois, 60612, United States
Evanston Illinois, 60201, United States
Park Ridge Illinois, 60068, United States
Louisville Kentucky, 40241, United States
Papillion Nebraska, 68046, United States
New York New York, 10029, United States
New York New York, 13210, United States
Rochester New York, 14642, United States
Greenville South Carolina, 29607, United States
Dallas Texas, 75246, United States
Antwerp , 2650, Belgium
Brussel , 1200, Belgium
Leuven , 3000, Belgium
Wilrijk , 2610, Belgium
Gralum , 1714, Norway
Kristiansand , 4615, Norway
Oslo , 4953, Norway
Stavanger , 4068, Norway
Tromsø , 9019, Norway
Trondheim , 7030, Norway
Ålesund , 6026, Norway
Bristol , BS2 8, United Kingdom
Cardiff , CF15 , United Kingdom
London , NW3 2, United Kingdom
London , SM2 7, United Kingdom
Manchester , M20 4, United Kingdom
Oxford , OX3 7, United Kingdom
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