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Malignant MelanomaPhase 1/2NCT02275416

Safety of UV1 Vaccination in Combination With Ipilimumab in Patients With Unresectable or Metastatic Malignant Melanoma

A Phase 1/2 study testing Ipilimumab, UV1 vaccine and GM-CSF in people with Malignant Melanoma, run by Ultimovacs ASA at 1 site in Norway.

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 study, with 20 patients participating, will examine the safety and tolerability for the ipilimumab/UV1 combination in patients with unresectable or metastatic malignant 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?
Ipilimumab, UV1 vaccine and GM-CSF
Type of treatment
Vaccines
Could I receive a placebo?
No, everyone receives an active treatment
How many people
12 participants
Where
1 siteNorway
Study dates
2 Feb 2015to 3 Nov 2020
Phase
Phase 1/2
Are there results?
None posted in the registry

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

  • Histologically or cytologically confirmed diagnosis of unresectable or metastatic malignant melanoma, including cutaneous, ocular, mucosal and unknown primary tumour.
  • Unresectable Stage III or Stage IV melanoma (AJCC 2010)
  • Prior adjuvant melanoma therapy is permitted; any number of previous treatments for melanoma is permitted.
  • ECOG performance status of 0 or 1 (see Error! Reference source not found.).
  • Men and women ≥ 18 years of age
  • Adequate hematologic, renal and hepatic function, specifically:
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  • WBC ≥ 2500/μL
  • Absolute neutrophil count (ANC) ≥ 1000/uL
  • Platelets ≥ 75 x 103/μL
  • Haemoglobin ≥ 9 g/dL
  • Creatinine ≤ 2.5 x ULN
  • AST/ALT ≤ 3 x ULN for patients without liver metastasis; ≤ 5 x ULN for patients with liver metastasis
  • Total bilirubin ≤ 3 x ULN, (except patients with Gilbert's Syndrome, who must have a total bilirubin less than 3.0 mg/dL)
  • Women of childbearing potential and men must be using an acceptable method as described in the protocol to prevent pregnancy.
  • Signed informed consent and expected cooperation of the patients for the treatment and follow up must be obtained and documented according to ICH GCP, and national/local regulations.

Who cannot join

  • History of or current active autoimmune diseases, including but not limited to inflammatory bowel diseases, rheumatoid arthritis, autoimmune thyroiditis, autoimmune hepatitis, systemic sclerosis (scleroderma and variants), systemic lupus erythematosus, autoimmune vasculitis, autoimmune neuropathies (e.g. Guillain-Barre syndrome). Patients with vitiligo are not excluded.
  • MRI detected active brain metastasis witch require other therapies such as surgery and/or radiation therapy. Patients already treated for their brain metastasis, surgery or radiation therapy, and have had stable disease for more than two month and NOT requiring steroids may however be included in this study.
  • Uncontrolled infectious diseases - requires negative tests for clinically suspected human immunodeficiency virus (HIV), hepatitis B virus (HBV) and hepatitis C virus (HCV).
  • History of or current immunodeficiency disease, splenectomy or splenic irradiation
  • Prior allogeneic stem cell transplantation
  • Pregnancy
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  • Women who are breastfeeding
  • Any underlying medical or psychiatric condition, which in the opinion of the Investigator, will make the administration of study drug hazardous or obscure the interpretation of Adverse Events, such as a condition associated with frequent diarrhoea
  • History of allergic reaction to parenteral administered recombinant protein product
  • History of another malignancy that in the opinion of the investigator may compromise the outcome of the study
  • Any reason why, in the opinion of the investigator, the patient should not participate.
  • Known serious reactions or hypersensitivity to any components of the UV1 vaccine or similar peptide based vaccines
  • Known hypersensitivity to GM-CSF
  • Known hypersensitivity to any of the excipients of the investigational products
  • Concomitant use of antithrombotic agents with the exception of platelet inhibitors.

Trial locations and contacts

1 site in 1 country.

Norway1 site

  • Oslo University Hospital, Radiumhospitalet

    Oslo, 0379

Other trials in Norway

About this study

This study, with 20 patients participating, will examine the safety and tolerability for the ipilimumab/UV1 combination in patients with unresectable or metastatic malignant melanoma.

Read the detailed description

This is a phase I/IIa, national, open label, single arm, interventional study examining safety and tolerability for the ipilimumab/UV1 combination in patients with unresectable or metastatic malignant melanoma. Patients that have signed the informed consent form will be asked to take part in the study. All patients will receive ipilimumab together with the UV1 vaccine and rranulocyte-macrophage colony-stimulating factor (GM-CSF). Ipilimumab will be given every 3rd week for a total of 4 doses. The UV1 vaccine and GM-CSF will be given before and between treatments of ipilimumab. The maximum number of UV1/GM-CSF will be 10 doses.

Immunoresponders maybe followed up every third months for 5 years after the first UV1 treatment. Follow-up is onging.

Being tested
Ipilimumab, UV1 vaccine, GM-CSF
Medical subject headings
Melanoma

What participants receive

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

  • IpilimumabDrug

    Also called Yervoy

  • UV1 vaccineBiological

    Also called UV1

  • GM-CSFBiological

    Also called Leukine

Study groups in NCT02275416
Study groupRoleWhat they receive
Ipilimumab & UV1 vaccine & GM-CSFExperimentalIpilimumab (3 mg/kg) every 3rd week for a total of 4 doses. GM-CSF (75 μg) followed by UV1 vaccine (300 μg) will be injected intradermally in the lower abdomen before and between treatments of ipilimumab and thereafter every 4th week up to 28 weeks, and thereafter at week 36 and 48.
Receives: Drug: Ipilimumab; Biological: UV1 vaccine; Biological: GM-CSF

What is being measured

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

  1. Safety and tolerability profile. Frequency/ severity of adverse and serious adverse events. Biochemistry and hematology results, vital signs and ECOG

    Frequency and severity of adverse events and serious adverse events. Biochemistry and hematology results, vital signs and ECOG performance status will be assessed.

    Measured: Up to 53 weeks

Secondary outcomes (3)

  1. Immunological response. Number of T-cell responses including time to T-cell response, level of response and duration of response.

    Number of T-cell responses including time to T-cell response, level of response and duration of response.

    Measured: Up to 53 weeks

  2. Treatment response. Tumour response evaluated by CT scan every 12th week.

    Tumour response evaluated by CT scan every 12th week.

    Measured: Up to 48 weeks

  3. Health Related Quality of Life (HRQL)

    HRQL measured by use of patient questionnaire EORTC QLQ-C30

    Measured: Up to 53 weeks

Timeline

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

  1. First posted27 Oct 2014 (estimated)
  2. Study start2 Feb 2015
  3. Primary completion6 Oct 2016
  4. Study completion3 Nov 2020

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 1/2
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
12 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT02275416
Sponsor's protocol ID
UV1/hTERT-MM
Other IDs
2013-005582-39
Status last verified
Dec 2024
First submitted
12 Sep 2014
Last updated
16 Dec 2024
Results posted
No
Data monitoring committee
Yes

Publications

  • Ellingsen EB, Bounova G, Kerzeli I, Anzar I, Simnica D, Aamdal E, Guren T, Clancy T, Mezheyeuski A, Inderberg EM, Mangsbo SM, Binder M, Hovig E, Gaudernack G. Characterization of the T cell receptor repertoire and melanoma tumor microenvironment upon combined treatment with ipilimumab and hTERT vaccination. J Transl Med. 2022 Sep 11;20(1):419. doi: 10.1186/s12967-022-03624-z.

    PubMed 36089578

  • Aamdal E, Inderberg EM, Ellingsen EB, Rasch W, Brunsvig PF, Aamdal S, Heintz KM, Vodak D, Nakken S, Hovig E, Nyakas M, Guren TK, Gaudernack G. Combining a Universal Telomerase Based Cancer Vaccine With Ipilimumab in Patients With Metastatic Melanoma - Five-Year Follow Up of a Phase I/IIa Trial. Front Immunol. 2021 May 11;12:663865. doi: 10.3389/fimmu.2021.663865. eCollection 2021.

    PubMed 34046035

Questions about this trial

What is this clinical trial studying?

A Phase 1/2 study testing Ipilimumab, UV1 vaccine and GM-CSF in people with Malignant Melanoma, run by Ultimovacs ASA at 1 site in Norway.

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 15 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 16 Dec 2024. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Norway. 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 combined phase mean?

Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.

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?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

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?

Safety and tolerability profile. Frequency/ severity of adverse and serious adverse events. Biochemistry and hematology results, vital signs and ECOG (time frame: Up to 53 weeks). 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 NCT02275416, which also lists 2 linked publications.

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 16 Dec 2024.

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