Status:
COMPLETED
Safety of UV1 Vaccination in Combination With Ipilimumab in Patients With Unresectable or Metastatic Malignant Melanoma
Lead Sponsor:
Ultimovacs ASA
Collaborating Sponsors:
Oslo University Hospital
Conditions:
Malignant Melanoma
Eligibility:
All Genders
18+ years
Phase:
PHASE1
PHASE2
Brief 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.
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...
Eligibility Criteria
Inclusion
- 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:
- 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.
Exclusion
- 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
- 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.
Key Trial Info
Start Date :
February 2 2015
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
November 3 2020
Estimated Enrollment :
12 Patients enrolled
Trial Details
Trial ID
NCT02275416
Start Date
February 2 2015
End Date
November 3 2020
Last Update
December 16 2024
Active Locations (1)
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1
Oslo University Hospital, Radiumhospitalet
Oslo, Norway, 0379