UV1 Vaccination Plus Nivolumab and Ipilimumab in Treatment of Melanoma

Study Purpose

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.

Recruitment Criteria

Accepts Healthy Volunteers

Healthy volunteers are participants who do not have a disease or condition, or related conditions or symptoms

No
Study Type

An interventional clinical study is where participants are assigned to receive one or more interventions (or no intervention) so that researchers can evaluate the effects of the interventions on biomedical or health-related outcomes.


An observational clinical study is where participants identified as belonging to study groups are assessed for biomedical or health outcomes.


Searching Both is inclusive of interventional and observational studies.

Interventional
Eligible Ages 18 Years and Over
Gender All
More Inclusion & Exclusion Criteria

Inclusion Criteria:

1. Male or female patients at least 18 years of age at the time of signing the ICF. 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:

1. 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. 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.

Trial Details

Trial ID:

This trial id was obtained from ClinicalTrials.gov, a service of the U.S. National Institutes of Health, providing information on publicly and privately supported clinical studies of human participants with locations in all 50 States and in 196 countries.

NCT04382664
Phase

Phase 1: Studies that emphasize safety and how the drug is metabolized and excreted in humans.

Phase 2: Studies that gather preliminary data on effectiveness (whether the drug works in people who have a certain disease or condition) and additional safety data.

Phase 3: Studies that gather more information about safety and effectiveness by studying different populations and different dosages and by using the drug in combination with other drugs.

Phase 4: Studies occurring after FDA has approved a drug for marketing, efficacy, or optimal use.

Phase 2
Lead Sponsor

The sponsor is the organization or person who oversees the clinical study and is responsible for analyzing the study data.

Ultimovacs ASA
Principal Investigator

The person who is responsible for the scientific and technical direction of the entire clinical study.

Karl Lewis
Principal Investigator Affiliation University of Colorado Hospital - Anschutz Cancer Pavilion
Agency Class

Category of organization(s) involved as sponsor (and collaborator) supporting the trial.

Industry
Overall Status Recruiting
Countries Belgium, Norway, United Kingdom, United States
Conditions

The disease, disorder, syndrome, illness, or injury that is being studied.

Malignant Melanoma
Additional Details

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.

Arms & Interventions

Arms

Experimental: UV1 vaccination + nivolumab and ipilimumab

UV1 vaccination + nivolumab and ipilimumab

Active Comparator: Nivolumab and ipilimumab

nivolumab and ipilimumab

Interventions

Biological: - UV1

UV1 vaccine (300 μg) will be injected intradermally.

Biological: - Sargramostim

Sargramostim (75 μg) is used as a vaccine adjuvant.

Biological: - Ipilimumab

Ipilimumab is dosed according to label.

Biological: - Nivolumab

Nivolumab is dosed according to label.

Contact a Trial Team

If you are interested in learning more about this trial, find the trial site nearest to your location and contact the site coordinator via email or phone. We also strongly recommend that you consult with your healthcare provider about the trials that may interest you and refer to our terms of service below.

Mayo Clinic Hospital, Phoenix, Arizona

Status

Recruiting

Address

Mayo Clinic Hospital

Phoenix, Arizona, 85016-4880

Highlands Oncology Group, Fayetteville, Arkansas

Status

Recruiting

Address

Highlands Oncology Group

Fayetteville, Arkansas, 72703

University of California Irvine Health, Orange, California

Status

Recruiting

Address

University of California Irvine Health

Orange, California, 92868

San Marcos, California

Status

Recruiting

Address

California Cancer Associates for Research & Excellence (CCARE

San Marcos, California, 92083

Ridley-Tree Cancer Center, Santa Barbara, California

Status

Not yet recruiting

Address

Ridley-Tree Cancer Center

Santa Barbara, California, 93105

Santa Monica, California

Status

Recruiting

Address

Saint John's Health Center - John Wayne Cancer Institute (JWCI)

Santa Monica, California, 90404

Aurora, Colorado

Status

Recruiting

Address

University of Colorado Hospital - Anschutz Cancer Pavilion

Aurora, Colorado, 80045

Holy Cross Medical Group, Fort Lauderdale, Florida

Status

Recruiting

Address

Holy Cross Medical Group

Fort Lauderdale, Florida, 33308

Sylvester Comprehensive Cancer Center, Miami, Florida

Status

Recruiting

Address

Sylvester Comprehensive Cancer Center

Miami, Florida, 33136-1002

Ocala Oncology Center, Ocala, Florida

Status

Recruiting

Address

Ocala Oncology Center

Ocala, Florida, 34474

Chicago, Illinois

Status

Recruiting

Address

Rush University Medical Center - Rush University Cancer Center

Chicago, Illinois, 60612-3841

NorthShore University Research Institute, Evanston, Illinois

Status

Recruiting

Address

NorthShore University Research Institute

Evanston, Illinois, 60201-1718

Oncology Specialists, S.C., Park Ridge, Illinois

Status

Recruiting

Address

Oncology Specialists, S.C.

Park Ridge, Illinois, 60068

Norton Cancer Institute, Louisville, Kentucky

Status

Recruiting

Address

Norton Cancer Institute

Louisville, Kentucky, 40241

Papillion, Nebraska

Status

Recruiting

Address

Nebraska Cancer Specialists- Midwest Cancer Center

Papillion, Nebraska, 68046-5706

Lebanon, New Hampshire

Status

Not yet recruiting

Address

Dartmouth-Hitchcock Medical Center (DHMC) - Norris Cotton Cancer Center - Lebanon

Lebanon, New Hampshire, 03756-1000

Icahn School of Medicine at Mount Sinai, New York, New York

Status

Recruiting

Address

Icahn School of Medicine at Mount Sinai

New York, New York, 10029

New York, New York

Status

Recruiting

Address

State University of New York (SUNY) Upstate Medical University

New York, New York, 13210

University of Rochester, Rochester, New York

Status

Recruiting

Address

University of Rochester

Rochester, New York, 14642-0001

NorthShore University HealthSystem, Greenville, South Carolina

Status

Recruiting

Address

NorthShore University HealthSystem

Greenville, South Carolina, 29607

Dallas, Texas

Status

Recruiting

Address

Texas Oncology - Baylor Charles A. Sammons Cancer Center

Dallas, Texas, 75246-2092

International Sites

Antwerp University Hospital, Antwerp, Belgium

Status

Recruiting

Address

Antwerp University Hospital

Antwerp, , 2650

Cliniques Universitaires Saint-Luc, Brussel, Belgium

Status

Recruiting

Address

Cliniques Universitaires Saint-Luc

Brussel, , 1200

Leuven University Hospital, Leuven, Belgium

Status

Recruiting

Address

Leuven University Hospital

Leuven, , 3000

GZA Hospital Sint-Augustinus, Wilrijk, Belgium

Status

Recruiting

Address

GZA Hospital Sint-Augustinus

Wilrijk, , 2610

Sykehuset Østfold HF, Gralum, Norway

Status

Recruiting

Address

Sykehuset Østfold HF

Gralum, , 1714

Sørlandet Sykehus HF(SSHF), Kristiansand, Norway

Status

Recruiting

Address

Sørlandet Sykehus HF(SSHF)

Kristiansand, , 4615

Oslo, Norway

Status

Recruiting

Address

Oslo University Hospital - The Norwegian Radium Hospital

Oslo, , 4953

Stavanger University Hospital, Stavanger, Norway

Status

Recruiting

Address

Stavanger University Hospital

Stavanger, , 4068

Universitetssykehuset Nord-Norge HF, Tromsø, Norway

Status

Recruiting

Address

Universitetssykehuset Nord-Norge HF

Tromsø, , 9019

St. Olavs Hospital HF, Trondheim, Norway

Status

Recruiting

Address

St. Olavs Hospital HF

Trondheim, , 7030

Ålesund Hospital- Helse Sunnmore HF, Ålesund, Norway

Status

Recruiting

Address

Ålesund Hospital- Helse Sunnmore HF

Ålesund, , 6026

Bristol, United Kingdom

Status

Recruiting

Address

University Hospitals Bristol NHS Foundation Trust - Bristol Haematology and Oncology Centre

Bristol, , BS2 8ED

Velindre NHS Trust, Cardiff, United Kingdom

Status

Recruiting

Address

Velindre NHS Trust

Cardiff, , CF15 7QZ

Chelmsford, United Kingdom

Status

Not yet recruiting

Address

Colchester Hospital University NHS Foundation Trust - Essex County Hospital

Chelmsford, , CM1 7ET

London, United Kingdom

Status

Recruiting

Address

The Royal Free London NHS Foundation Trust - The Royal Free Hospital

London, , NW3 2QG

London, United Kingdom

Status

Recruiting

Address

Royal Marsden Hospital - Institute of Cancer Research - Chelsea

London, , SM2 7LN

Cancer Research UK Manchester Institute, Manchester, United Kingdom

Status

Recruiting

Address

Cancer Research UK Manchester Institute

Manchester, , M20 4BX

Oxford, United Kingdom

Status

Recruiting

Address

Oxford University Hospitals NHS Trust - Churchill Hospital

Oxford, , OX3 7LE

Sutton, United Kingdom

Status

Not yet recruiting

Address

The Royal Marsden NHS Foundation Trust - Institute of Cancer Research (ICR) - Sutton

Sutton, , SM2 5PT

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