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Safety of UV1 Vaccination in Combination With Ipilimumab in Patients With Unresectable or Metastatic Malignant Melanoma | Clinical Trials | Clareo Health

COMPLETEDPHASE1/PHASE2

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

NCT02275416•Ultimovacs ASA

View on ClinicalTrials.gov

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 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.

Eligibility

Age

18 - No limit years

Sex

ALL

Healthy Volunteers

Inclusion Criteria

•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/μL
•2. Absolute neutrophil count (ANC) ≥ 1000/uL
•3. Platelets ≥ 75 x 103/μL
•4. Haemoglobin ≥ 9 g/dL
+5 more criteria

Exclusion Criteria

•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 (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
+5 more criteria

Locations (1)

Oslo University Hospital, Radiumhospitalet

Oslo, Norway

Key Dates

Start Date

February 2, 2015

Primary Completion Date

October 6, 2016

Completion Date

November 3, 2020

Last Updated

December 16, 2024

Enrollment

ACTUAL participants

Conditions

Malignant Melanoma

Interventions

Ipilimumab

DRUG

UV1 vaccine

BIOLOGICAL

GM-CSF

BIOLOGICAL

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Solid CancersNSCLC (Advanced Non-small Cell Lung Cancer)+3 more

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RECRUITINGPHASE1/PHASE2

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Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: December 16, 2024Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

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

Inclusion Criteria

Exclusion Criteria

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