Safety of UV1 Vaccination in Combination With Ipilimumab in Patients With Unresectable or Metastatic Malignant Melanoma
NCT ID: NCT02275416
Last Updated: 2024-12-16
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE1/PHASE2
12 participants
INTERVENTIONAL
2015-02-02
2020-11-03
Brief Summary
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Detailed Description
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Immunoresponders maybe followed up every third months for 5 years after the first UV1 treatment. Follow-up is onging.
Conditions
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Study Design
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NA
SINGLE_GROUP
TREATMENT
NONE
Study Groups
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Ipilimumab & UV1 vaccine & GM-CSF
Ipilimumab (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.
Ipilimumab
UV1 vaccine
GM-CSF
Interventions
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Ipilimumab
UV1 vaccine
GM-CSF
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
2. Unresectable Stage III or Stage IV melanoma (AJCC 2010)
3. Prior adjuvant melanoma therapy is permitted; any number of previous treatments for melanoma is permitted.
4. ECOG performance status of 0 or 1 (see Error! Reference source not found.).
5. Men and women ≥ 18 years of age
6. Adequate hematologic, renal and hepatic function, specifically:
1. WBC ≥ 2500/μL
2. Absolute neutrophil count (ANC) ≥ 1000/uL
3. Platelets ≥ 75 x 103/μL
4. Haemoglobin ≥ 9 g/dL
5. Creatinine ≤ 2.5 x ULN
6. AST/ALT ≤ 3 x ULN for patients without liver metastasis; ≤ 5 x ULN for patients with liver metastasis
7. Total bilirubin ≤ 3 x ULN, (except patients with Gilbert's Syndrome, who must have a total bilirubin less than 3.0 mg/dL)
7. Women of childbearing potential and men must be using an acceptable method as described in the protocol to prevent pregnancy.
8. 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.
Exclusion Criteria
2. 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.
3. Uncontrolled infectious diseases - requires negative tests for clinically suspected human immunodeficiency virus (HIV), hepatitis B virus (HBV) and hepatitis C virus (HCV).
4. History of or current immunodeficiency disease, splenectomy or splenic irradiation
5. Prior allogeneic stem cell transplantation
6. Pregnancy
7. Women who are breastfeeding
8. 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
9. History of allergic reaction to parenteral administered recombinant protein product
10. History of another malignancy that in the opinion of the investigator may compromise the outcome of the study
11. Any reason why, in the opinion of the investigator, the patient should not participate.
12. Known serious reactions or hypersensitivity to any components of the UV1 vaccine or similar peptide based vaccines
13. Known hypersensitivity to GM-CSF
14. Known hypersensitivity to any of the excipients of the investigational products
15. Concomitant use of antithrombotic agents with the exception of platelet inhibitors.
18 Years
ALL
No
Sponsors
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Oslo University Hospital
OTHER
Ultimovacs ASA
INDUSTRY
Responsible Party
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Principal Investigators
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Tormod Guren, MD PhD
Role: PRINCIPAL_INVESTIGATOR
Oslo University Hospital
Locations
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Oslo University Hospital, Radiumhospitalet
Oslo, , Norway
Countries
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References
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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.
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.
Other Identifiers
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2013-005582-39
Identifier Type: EUDRACT_NUMBER
Identifier Source: secondary_id
UV1/hTERT-MM
Identifier Type: -
Identifier Source: org_study_id