UV1 Vaccination Plus Nivolumab and Ipilimumab in Treatment of Melanoma

NCT04382664 | Completed Phase 2 Results FDA Drug

• 1 other identifier: UV1-202
• Study Type: interventional
• Target: 156
• Locations: 4 countries
• Sites: 37

Brief Summary

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.

Conditions

Malignant Melanoma

Outcome Measures

Primary Outcomes (1)

• PFS Per Response Evaluation Criteria in Solid Tumors (RECIST) 1.1 (by Blinded Independent Central Review (BICR)

  Compare progression free survival (PFS) of UV1 vaccination in combination with nivolumab and ipilimumab to that of nivolumab and ipilimumab

  Time from randomization to progressive disease (PD) or death from any cause (approximately 44 months)

Secondary Outcomes (4)

• Overall Survival

  Time from randomization to death from any cause /follow-up until 70 PFS events/18 months post rand, approximately 44 months.

• ORR Per RECIST 1.1

  Number of complete and partial responses during the study, approximately 44 months.

• DOR Per RECIST 1.1

  Time from first CR or PR to PD or death from any cause, approximately 44 months.

• Evaluation of Adverse Events, Vital Signs, Laboratory Assessments and ECOG Performance Status

  Time from randomization to end of study, approximately 47 months.

Other Outcomes (1)

• Immunological Mechanisms

  Time from randomization to end of study to readout of primary objectives, approximately 44 months.

Study Arms (2)

UV1 vaccination + nivolumab and ipilimumab

EXPERIMENTAL

UV1 vaccination + nivolumab and ipilimumab

Biological: UV1; Biological: Sargramostim; Biological: Ipilimumab; Biological: Nivolumab

Nivolumab and ipilimumab

ACTIVE COMPARATOR

Nivolumab and ipilimumab

Biological: Ipilimumab; Biological: Nivolumab

Interventions

UV1 BIOLOGICAL

UV1 vaccine (300 μg) will be injected intradermally.

UV1 vaccination + nivolumab and ipilimumab

Sargramostim BIOLOGICAL

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

Also known as: Leukine

UV1 vaccination + nivolumab and ipilimumab

Ipilimumab BIOLOGICAL

Ipilimumab is dosed according to label.

Also known as: Yervoy

Nivolumab and ipilimumab; UV1 vaccination + nivolumab and ipilimumab

Nivolumab BIOLOGICAL

Nivolumab is dosed according to label.

Also known as: Opdivo

Nivolumab and ipilimumab; UV1 vaccination + nivolumab and ipilimumab

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Ultimovacs ASA: lead

Study Sites (37)

Mayo Clinic Hospital

Phoenix, Arizona, 85016-4880, United States

Location

Highlands Oncology Group

Fayetteville, Arkansas, 72703, United States

Location

University of California Irvine Health

Orange, California, 92868, United States

Location

California Cancer Associates for Research & Excellence (CCARE

San Marcos, California, 92083, United States

Location

Ridley-Tree Cancer Center

Santa Barbara, California, 93105, United States

Location

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

Santa Monica, California, 90404, United States

Location

University of Colorado Hospital - Anschutz Cancer Pavilion

Aurora, Colorado, 80045, United States

Location

Holy Cross Medical Group

Fort Lauderdale, Florida, 33308, United States

Location

Sylvester Comprehensive Cancer Center

Miami, Florida, 33136-1002, United States

Location

Ocala Oncology Center

Ocala, Florida, 34474, United States

Location

Rush University Medical Center - Rush University Cancer Center

Chicago, Illinois, 60612-3841, United States

Location

NorthShore University Research Institute

Evanston, Illinois, 60201-1718, United States

Location

Oncology Specialists, S.C.

Park Ridge, Illinois, 60068, United States

Location

Norton Cancer Institute

Louisville, Kentucky, 40241, United States

Location

Nebraska Cancer Specialists- Midwest Cancer Center

Papillion, Nebraska, 68046-5706, United States

Location

Icahn School of Medicine at Mount Sinai

New York, New York, 10029, United States

Location

State University of New York (SUNY) Upstate Medical University

New York, New York, 13210, United States

Location

University of Rochester

Rochester, New York, 14642-0001, United States

Location

NorthShore University HealthSystem

Greenville, South Carolina, 29607, United States

Location

Texas Oncology - Baylor Charles A. Sammons Cancer Center

Dallas, Texas, 75246-2092, United States

Location

Antwerp University Hospital

Antwerp, 2650, Belgium

Location

Cliniques Universitaires Saint-Luc

Brussels, 1200, Belgium

Location

Leuven University Hospital

Leuven, 3000, Belgium

Location

GZA Hospital Sint-Augustinus

Wilrijk, 2610, Belgium

Location

Ålesund Hospital- Helse Sunnmore HF

Ålesund, 6026, Norway

Location

Sykehuset Østfold HF

Grålum, 1714, Norway

Location

Sørlandet Sykehus HF(SSHF)

Kristiansand, 4615, Norway

Location

Oslo University Hospital - The Norwegian Radium Hospital

Oslo, 4953, Norway

Location

Stavanger University Hospital

Stavanger, 4068, Norway

Location

Universitetssykehuset Nord-Norge HF

Tromsø, 9019, Norway

Location

St. Olavs Hospital HF

Trondheim, 7030, Norway

Location

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

Bristol, BS2 8ED, United Kingdom

Location

Velindre NHS Trust

Cardiff, CF15 7QZ, United Kingdom

Location

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

London, NW3 2QG, United Kingdom

Location

Royal Marsden Hospital - Institute of Cancer Research - Chelsea

London, SM2 7LN, United Kingdom

Location

Cancer Research UK Manchester Institute

Manchester, M20 4BX, United Kingdom

Location

Oxford University Hospitals NHS Trust - Churchill Hospital

Oxford, OX3 7LE, United Kingdom

Location

MeSH Terms

Conditions

Melanoma

Interventions

sargramostim; Ipilimumab; Nivolumab

Condition Hierarchy (Ancestors)

Neuroendocrine Tumors; Neuroectodermal Tumors; Neoplasms, Germ Cell and Embryonal; Neoplasms by Histologic Type; Neoplasms; Neoplasms, Nerve Tissue; Nevi and Melanomas; Skin Neoplasms; Neoplasms by Site; Skin Diseases; Skin and Connective Tissue Diseases

Intervention Hierarchy (Ancestors)

Antibodies, Monoclonal, Humanized; Antibodies, Monoclonal; Antibodies; Immunoglobulins; Immunoproteins; Blood Proteins; Proteins; Amino Acids, Peptides, and Proteins; Serum Globulins; Globulins

Results Point of Contact

• Title: Øivind Foss, Head of Clinical Operation
• Organization: Ultimovacs ASA

oivind.foss@ultimovacs.com

97008357

Study Officials

• Karl Lewis

  University of Colorado Hospital - Anschutz Cancer Pavilion

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 27, 2020
• First Posted: May 11, 2020
• Study Start: May 27, 2020
• Primary Completion: January 11, 2024
• Study Completion: April 10, 2024
• Last Updated: January 14, 2025
• Results First Posted: January 14, 2025

Record last verified: 2025-01

Locations

NO (7); GB (6); US (20); BE (4)