Clinical Trial TitleA Randomized Phase II, Open label, Active controlled, Study Investigating the Efficacy and Safety of UV1 Vaccination in Combination with Nivolumab and Ipilimumab as First line Treatment of Patients with Unresectable or Metastatic Melanoma (UV1-202)
National Clinical Trial Number:NCT04382664
Clinical Trial Protocol Description:
This study is a part of the development of the UV1 vaccination for the treatment of unresectable or metastatic melanoma. The purpose of this study is to investigate the efficacy and safety of UV1 vaccination in combination with nivolumab and ipilimumab as a first treatment for adult patients with confirmed unresectable or metastatic melanoma. Participants, who qualify for this study will be assigned by chance to get one of the following treatments:
- Treatment A: UV1 vaccination + nivolumab + ipilimumab
- Treatment B: Nivolumab + ipilimumab
Clinical Trial Eligibility Criteria:
In order to participate you must meet the following criteria:
- Are male or female and at least 18 years of age at the time of signing the ICF.
- Have histologically confirmed diagnosis of unresectable stage IIIB D, or unresectable stage IV malignant melanoma.
- Are eligible for combination treatment with nivolumab and ipilimumab.
- Have an ECOG performance status of 0 or 1.
You will be excluded from the study if any of the following criteria apply to you:
- Have known brain metastases or leptomeningeal metastases. If a patient experiences neurological symptoms indicative of brain metastases, a brain MRI should be performed.
- Have a diagnosis of uveal or ocular melanoma.
- Have known history or any evidence of active, non-infectious pneumonitis.
- Have a diagnosis of immunodeficiency.
This is a partial list of eligibility requirements. To inquire about your eligibility, please call the contact number provided. If you wish to inquire via email, please include the title of the study in your message.