Spots Global Cancer Trial Database for UV1 Vaccination Plus Nivolumab and Ipilimumab in Treatment of Melanoma
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Trial Identification
Brief Title: UV1 Vaccination Plus Nivolumab and Ipilimumab in Treatment of Melanoma
Official Title: Efficacy and Safety of UV1 Vaccination in Combination With Nivolumab and Ipilimumab as First Line Treatment of Patients With Unresectable or Metastatic Melanoma (INITIUM Study)
Study ID: NCT04382664
Conditions
Study Description
Brief 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.
Detailed 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.
Keywords
Eligibility
Minimum Age: 18 Years
Eligible Ages: ADULT, OLDER_ADULT
Sex: ALL
Healthy Volunteers: No
Locations
Mayo Clinic Hospital, Phoenix, Arizona, United States
Highlands Oncology Group, Fayetteville, Arkansas, United States
University of California Irvine Health, Orange, California, United States
California Cancer Associates for Research & Excellence (CCARE, San Marcos, California, United States
Ridley-Tree Cancer Center, Santa Barbara, California, United States
Saint John's Health Center - John Wayne Cancer Institute (JWCI), Santa Monica, California, United States
University of Colorado Hospital - Anschutz Cancer Pavilion, Aurora, Colorado, United States
Holy Cross Medical Group, Fort Lauderdale, Florida, United States
Sylvester Comprehensive Cancer Center, Miami, Florida, United States
Ocala Oncology Center, Ocala, Florida, United States
Rush University Medical Center - Rush University Cancer Center, Chicago, Illinois, United States
NorthShore University Research Institute, Evanston, Illinois, United States
Oncology Specialists, S.C., Park Ridge, Illinois, United States
Norton Cancer Institute, Louisville, Kentucky, United States
Nebraska Cancer Specialists- Midwest Cancer Center, Papillion, Nebraska, United States
Icahn School of Medicine at Mount Sinai, New York, New York, United States
State University of New York (SUNY) Upstate Medical University, New York, New York, United States
University of Rochester, Rochester, New York, United States
NorthShore University HealthSystem, Greenville, South Carolina, United States
Texas Oncology - Baylor Charles A. Sammons Cancer Center, Dallas, Texas, United States
Antwerp University Hospital, Antwerp, , Belgium
Cliniques Universitaires Saint-Luc, Brussel, , Belgium
Leuven University Hospital, Leuven, , Belgium
GZA Hospital Sint-Augustinus, Wilrijk, , Belgium
Sykehuset Østfold HF, Gralum, , Norway
Sørlandet Sykehus HF(SSHF), Kristiansand, , Norway
Oslo University Hospital - The Norwegian Radium Hospital, Oslo, , Norway
Stavanger University Hospital, Stavanger, , Norway
Universitetssykehuset Nord-Norge HF, Tromsø, , Norway
St. Olavs Hospital HF, Trondheim, , Norway
Ålesund Hospital- Helse Sunnmore HF, Ålesund, , Norway
University Hospitals Bristol NHS Foundation Trust - Bristol Haematology and Oncology Centre, Bristol, , United Kingdom
Velindre NHS Trust, Cardiff, , United Kingdom
The Royal Free London NHS Foundation Trust - The Royal Free Hospital, London, , United Kingdom
Royal Marsden Hospital - Institute of Cancer Research - Chelsea, London, , United Kingdom
Cancer Research UK Manchester Institute, Manchester, , United Kingdom
Oxford University Hospitals NHS Trust - Churchill Hospital, Oxford, , United Kingdom
Contact Details
Name: Karl Lewis
Affiliation: University of Colorado Hospital - Anschutz Cancer Pavilion
Role: PRINCIPAL_INVESTIGATOR
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