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|NCT02275416 : Safety of UV1 Vaccination in Combination With Ipilimumab in Patients With Unresectable or Metastatic Malignant Melanoma|
|Phase||Phase 1/Phase 2|
|Ages||Min: 18 Years Max: N/A|
1. Histologically or cytologically confirmed diagnosis of unresectable or metastatic
malignant melanoma, including cutaneous, ocular, mucosal and unknown primary tumour.
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/?L
2. Absolute neutrophil count (ANC) ? 1000/uL
3. Platelets ? 75 x 103/?L
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
1. 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.
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
4. History of or current immunodeficiency disease, splenectomy or splenic irradiation
5. Prior allogeneic stem cell transplantation
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
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
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.
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| Link to official Clinicaltrials.gov listing