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Malignant MelanomaPhase 2NCT04382664

UV1 Vaccination Plus Nivolumab and Ipilimumab in Treatment of Melanoma

A Phase 2 study testing UV1, Sargramostim and Ipilimumab in people with Malignant Melanoma, run by Ultimovacs ASA at 37 sites in 4 countries.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Malignant Melanoma
What is being tested?
UV1, Sargramostim and Ipilimumab
Type of treatment
Vaccines
Could I receive a placebo?
No, everyone receives an active treatment
How many people
156 participants
Where
37 sitesin 4 countries
Study dates
27 May 2020to 10 Apr 2024
Phase
Phase 2
Are there results?
Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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
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  • 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.

Who cannot join

  • 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.
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  • 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.
  • 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.

Trial locations and contacts

37 sites in 4 countries.

37 sites in 4 countries

United States20 sites

  • University of Colorado Hospital - Anschutz Cancer Pavilion

    Aurora, Colorado, 80045

  • Rush University Medical Center - Rush University Cancer Center

    Chicago, Illinois, 60612-3841

  • Texas Oncology - Baylor Charles A. Sammons Cancer Center

    Dallas, Texas, 75246-2092

  • NorthShore University Research Institute

    Evanston, Illinois, 60201-1718

  • Highlands Oncology Group

    Fayetteville, Arkansas, 72703

  • Holy Cross Medical Group

    Fort Lauderdale, Florida, 33308

  • NorthShore University HealthSystem

    Greenville, South Carolina, 29607

  • Norton Cancer Institute

    Louisville, Kentucky, 40241

  • Sylvester Comprehensive Cancer Center

    Miami, Florida, 33136-1002

  • Icahn School of Medicine at Mount Sinai

    New York, New York, 10029

  • State University of New York (SUNY) Upstate Medical University

    New York, New York, 13210

  • Ocala Oncology Center

    Ocala, Florida, 34474

  • University of California Irvine Health

    Orange, California, 92868

  • Nebraska Cancer Specialists- Midwest Cancer Center

    Papillion, Nebraska, 68046-5706

  • Oncology Specialists, S.C.

    Park Ridge, Illinois, 60068

  • Mayo Clinic Hospital

    Phoenix, Arizona, 85016-4880

  • University of Rochester

    Rochester, New York, 14642-0001

  • California Cancer Associates for Research & Excellence (CCARE

    San Marcos, California, 92083

  • Ridley-Tree Cancer Center

    Santa Barbara, California, 93105

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

    Santa Monica, California, 90404

Other trials in United States

Norway7 sites

  • Ålesund Hospital- Helse Sunnmore HF

    Ålesund, 6026

  • Sykehuset Østfold HF

    Grålum, 1714

  • Sørlandet Sykehus HF(SSHF)

    Kristiansand, 4615

  • Oslo University Hospital - The Norwegian Radium Hospital

    Oslo, 4953

  • Stavanger University Hospital

    Stavanger, 4068

  • Universitetssykehuset Nord-Norge HF

    Tromsø, 9019

  • St. Olavs Hospital HF

    Trondheim, 7030

Other trials in Norway

United Kingdom6 sites

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

    Bristol, BS2 8ED

  • Velindre NHS Trust

    Cardiff, CF15 7QZ

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

    London, NW3 2QG

  • Royal Marsden Hospital - Institute of Cancer Research - Chelsea

    London, SM2 7LN

  • Cancer Research UK Manchester Institute

    Manchester, M20 4BX

  • Oxford University Hospitals NHS Trust - Churchill Hospital

    Oxford, OX3 7LE

Other trials in United Kingdom

Belgium4 sites

  • Antwerp University Hospital

    Antwerp, 2650

  • Cliniques Universitaires Saint-Luc

    Brussels, 1200

  • Leuven University Hospital

    Leuven, 3000

  • GZA Hospital Sint-Augustinus

    Wilrijk, 2610

Other trials in Belgium

About this study

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)

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.

Read the 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 and will not be included in the main analysis of the study.

Being tested
UV1, Sargramostim, Ipilimumab, Nivolumab
Medical subject headings
Melanoma

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • UV1Biological

    UV1 vaccine (300 μg) will be injected intradermally.

  • SargramostimBiological

    Also called Leukine

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

  • IpilimumabBiological

    Also called Yervoy

    Ipilimumab is dosed according to label.

  • NivolumabBiological

    Also called Opdivo

    Nivolumab is dosed according to label.

Study groups in NCT04382664
Study groupRoleWhat they receive
UV1 vaccination + nivolumab and ipilimumabExperimentalUV1 vaccination + nivolumab and ipilimumab
Receives: Biological: UV1; Biological: Sargramostim; Biological: Ipilimumab; Biological: Nivolumab
Nivolumab and ipilimumabActive comparatorNivolumab and ipilimumab
Receives: Biological: Ipilimumab; Biological: Nivolumab

What is being measured

The primary outcome is the main question the study is designed to answer.

  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

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

Secondary outcomes (4)

  1. Overall Survival

    Compare Overall Survival of UV1 vaccination in combination with nivolumab and ipilimumab to that of nivolumab and ipilimumab .

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

  2. ORR Per RECIST 1.1

    Compare the objective response rate (ORR) of UV1 vaccination in combination with nivolumab and ipilimumab to that of nivolumab and ipilimumab.

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

  3. DOR Per RECIST 1.1

    Compare duration of response (DOR) of UV1 vaccination in combination with nivolumab and ipilimumab to that of nivolumab and ipilimumab.

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

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

    Compare the safety of UV1 vaccination in combination with nivolumab and ipilimumab to that of nivolumab and ipilimumab. Safety will be listed and summarized descriptively by treatment arm comparing number of participants with observation and changes from baseline and at each visit related to AEs, deaths, vital signs (weight (kg), systolic and diastolic blood pressure (mmHg), pulse rate (bpm), body temperature (°C)), laboratory assessments and ECOG performance status (Grade 0 - Grade 5).

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

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted11 May 2020
  2. Study start27 May 2020
  3. Primary completion11 Jan 2024
  4. Study completion10 Apr 2024

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 2
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
156 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04382664
Sponsor's protocol ID
UV1-202
Status last verified
Jan 2025
First submitted
27 Apr 2020
Last updated
14 Jan 2025
FDA-regulated drug
Yes
FDA-regulated device
No

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing UV1, Sargramostim and Ipilimumab in people with Malignant Melanoma, run by Ultimovacs ASA at 37 sites in 4 countries.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 15 inclusion and 16 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 14 Jan 2025. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 37 sites in United States, Norway, United Kingdom, Belgium. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 14 Jan 2025). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

PFS Per Response Evaluation Criteria in Solid Tumors (RECIST) 1.1 (by Blinded Independent Central Review (BICR) (time frame: Time from randomization to progressive disease (PD) or death from any cause (approximately 44 months)). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT04382664.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 14 Jan 2025.

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