Melanoma Clinical Trial

UV1 Vaccination Plus Nivolumab and Ipilimumab in Treatment of Melanoma

Summary

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.

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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.

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Eligibility Criteria

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

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.

Exclusion Criteria:

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.

Study is for people with:

Melanoma

Phase:

Phase 2

Estimated Enrollment:

154

Study ID:

NCT04382664

Recruitment Status:

Recruiting

Sponsor:

Ultimovacs ASA

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There are 40 Locations for this study

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Mayo Clinic Hospital
Phoenix Arizona, 85016, United States
Highlands Oncology Group
Fayetteville Arkansas, 72703, United States
University of California Irvine Health
Orange California, 92868, United States
California Cancer Associates for Research & Excellence (CCARE
San Marcos California, 92083, United States
Ridley-Tree Cancer Center
Santa Barbara California, 93105, United States
Saint John's Health Center - John Wayne Cancer Institute (JWCI)
Santa Monica California, 90404, United States
University of Colorado Hospital - Anschutz Cancer Pavilion
Aurora Colorado, 80045, United States
Holy Cross Medical Group
Fort Lauderdale Florida, 33308, United States
Sylvester Comprehensive Cancer Center
Miami Florida, 33136, United States
Ocala Oncology Center
Ocala Florida, 34474, United States
Rush University Medical Center - Rush University Cancer Center
Chicago Illinois, 60612, United States
NorthShore University Research Institute
Evanston Illinois, 60201, United States
Oncology Specialists, S.C.
Park Ridge Illinois, 60068, United States
Norton Cancer Institute
Louisville Kentucky, 40241, United States
Nebraska Cancer Specialists- Midwest Cancer Center
Papillion Nebraska, 68046, United States
Dartmouth-Hitchcock Medical Center (DHMC) - Norris Cotton Cancer Center - Lebanon
Lebanon New Hampshire, 03756, United States
Icahn School of Medicine at Mount Sinai
New York New York, 10029, United States
State University of New York (SUNY) Upstate Medical University
New York New York, 13210, United States
University of Rochester
Rochester New York, 14642, United States
NorthShore University HealthSystem
Greenville South Carolina, 29607, United States
Texas Oncology - Baylor Charles A. Sammons Cancer Center
Dallas Texas, 75246, United States
Antwerp University Hospital
Antwerp , 2650, Belgium
Cliniques Universitaires Saint-Luc
Brussel , 1200, Belgium
Leuven University Hospital
Leuven , 3000, Belgium
GZA Hospital Sint-Augustinus
Wilrijk , 2610, Belgium
Sykehuset Østfold HF
Gralum , 1714, Norway
Sørlandet Sykehus HF(SSHF)
Kristiansand , 4615, Norway
Oslo University Hospital - The Norwegian Radium Hospital
Oslo , 4953, Norway
Stavanger University Hospital
Stavanger , 4068, Norway
Universitetssykehuset Nord-Norge HF
Tromsø , 9019, Norway
St. Olavs Hospital HF
Trondheim , 7030, Norway
Ålesund Hospital- Helse Sunnmore HF
Ålesund , 6026, Norway
University Hospitals Bristol NHS Foundation Trust - Bristol Haematology and Oncology Centre
Bristol , BS2 8, United Kingdom
Velindre NHS Trust
Cardiff , CF15 , United Kingdom
Colchester Hospital University NHS Foundation Trust - Essex County Hospital
Chelmsford , CM1 7, United Kingdom
The Royal Free London NHS Foundation Trust - The Royal Free Hospital
London , NW3 2, United Kingdom
Royal Marsden Hospital - Institute of Cancer Research - Chelsea
London , SM2 7, United Kingdom
Cancer Research UK Manchester Institute
Manchester , M20 4, United Kingdom
Oxford University Hospitals NHS Trust - Churchill Hospital
Oxford , OX3 7, United Kingdom
The Royal Marsden NHS Foundation Trust - Institute of Cancer Research (ICR) - Sutton
Sutton , SM2 5, United Kingdom

How clear is this clinincal trial information?

Study is for people with:

Melanoma

Phase:

Phase 2

Estimated Enrollment:

154

Study ID:

NCT04382664

Recruitment Status:

Recruiting

Sponsor:


Ultimovacs ASA

How clear is this clinincal trial information?

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