UV1 Vaccination Plus Nivolumab and Ipilimumab in Treatment of Melanoma
NCT ID: NCT04382664
Last Updated: 2025-01-14
Study Results
Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.
View full resultsBasic Information
Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.
COMPLETED
PHASE2
156 participants
INTERVENTIONAL
2020-05-27
2024-04-10
Brief Summary
Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.
Related Clinical Trials
Explore similar clinical trials based on study characteristics and research focus.
Evaluation of Safety and Efficacy of Patients With Four and More Symptomatic Brain Metastases of Melanoma
NCT03728465
Ipilimumab With or Without Sargramostim in Treating Patients With Stage III or Stage IV Melanoma That Cannot Be Removed by Surgery
NCT01134614
Trial of Nivolumab in Combination With Ipilimumab in Subjects With Previously Untreated Metastatic Uveal Melanoma
NCT02626962
Ipilimumab and Nivolumab With Immunoembolization in Treating Participants With Metastatic Uveal Melanoma in the Liver
NCT03472586
Ipilumumab and Nivolumab With or Without Hypofractionated Radiotherapy in Patients With Metastatic Melanoma
NCT03646617
Detailed Description
Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.
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 and will not be included in the main analysis of the study.
Conditions
See the medical conditions and disease areas that this research is targeting or investigating.
Study Design
Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.
RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
Review each arm or cohort in the study, along with the interventions and objectives associated with them.
UV1 vaccination + nivolumab and ipilimumab
UV1 vaccination + nivolumab and ipilimumab
UV1
UV1 vaccine (300 μg) will be injected intradermally.
Sargramostim
Sargramostim (75 μg) is used as a vaccine adjuvant.
Ipilimumab
Ipilimumab is dosed according to label.
Nivolumab
Nivolumab is dosed according to label.
Nivolumab and ipilimumab
Nivolumab and ipilimumab
Ipilimumab
Ipilimumab is dosed according to label.
Nivolumab
Nivolumab is dosed according to label.
Interventions
Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.
UV1
UV1 vaccine (300 μg) will be injected intradermally.
Sargramostim
Sargramostim (75 μg) is used as a vaccine adjuvant.
Ipilimumab
Ipilimumab is dosed according to label.
Nivolumab
Nivolumab is dosed according to label.
Other Intervention Names
Discover alternative or legacy names that may be used to describe the listed interventions across different sources.
Eligibility Criteria
Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.
Inclusion Criteria
2. Histologically confirmed diagnosis of unresectable stage IIIB D, or unresectable stage IV malignant melanoma.
3. Eligible for combination treatment with nivolumab and ipilimumab.
4. An ECOG performance status of 0 or 1.
5. Adequate organ function as indicated by the following laboratory values:
Hematological
1. Absolute neutrophil count ≥1,500/µL
2. Platelet count ≥100 x 103/µL
3. Hemoglobin ≥9 g/dL or ≥5.6 mmol/L Renal
4. Creatinine ≤1.5 x upper limit of normal (ULN) Hepatic
5. Total bilirubin ≤1.5 x ULN or direct bilirubin ≤ ULN for patients with total bilirubin levels \>1.5 ULN
6. 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.
6. Male patients who are sexually active with a female of childbearing potential must agree to use an adequate method of contraception.
7. Women of childbearing potential (WOCBP) must have a negative urine or serum/plasma pregnancy test.
8. WOCBP must use adequate contraception.
Exclusion Criteria
2. Known brain metastases or leptomeningeal metastases. If a patient experiences neurological symptoms indicative of brain metastases, a brain MRI should be performed.
3. Diagnosis of uveal or ocular melanoma.
4. Known history or any evidence of active, non-infectious pneumonitis.
5. History of New York Heart Association class 3-4 congestive heart failure or history of myocardial infarction within 6 months of starting induction therapy.
6. Active infection requiring systemic treatment.
7. Diagnosis of immunodeficiency.
8. Known history of severe hypersensitivity reactions to nivolumab, ipilimumab, sargramostim, or their excipients.
9. Known history of human immunodeficiency virus (HIV) (HIV 1/2 antibodies).
10. History of or active hepatitis B (hepatitis B surface antigen reactive) or active hepatitis C (hepatitis C virus antibody).
11. Women who are breastfeeding.
12. Prior systemic treatment for unresectable stage IIIB D or unresectable stage IV malignant melanoma.
13. 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.
14. Receipt of a live vaccine within 30 days prior to start of induction therapy.
15. Receipt of any other investigational treatment within 4 weeks of the first dose of induction therapy.
16. Any medical, psychological, or social condition that would make it difficult for the patient to participate in the study and comply with the study procedures, restrictions and requirements.
18 Years
ALL
No
Sponsors
Meet the organizations funding or collaborating on the study and learn about their roles.
Ultimovacs ASA
INDUSTRY
Responsible Party
Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.
Principal Investigators
Learn about the lead researchers overseeing the trial and their institutional affiliations.
Karl Lewis
Role: PRINCIPAL_INVESTIGATOR
University of Colorado Hospital - Anschutz Cancer Pavilion
Locations
Explore where the study is taking place and check the recruitment status at each participating site.
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
Brussels, , Belgium
Leuven University Hospital
Leuven, , Belgium
GZA Hospital Sint-Augustinus
Wilrijk, , Belgium
Ålesund Hospital- Helse Sunnmore HF
Ålesund, , Norway
Sykehuset Østfold HF
Grålum, , 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
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
Countries
Review the countries where the study has at least one active or historical site.
Provided Documents
Download supplemental materials such as informed consent forms, study protocols, or participant manuals.
Document Type: Study Protocol and Statistical Analysis Plan
Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
UV1-202
Identifier Type: -
Identifier Source: org_study_id
More Related Trials
Additional clinical trials that may be relevant based on similarity analysis.