UV1 Vaccination combined with Nivolumab and Ipilimumab for Melanoma
Research type
Research Study
Full title
A Randomized Phase II, Open-label, Active-controlled, Multicenter 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)
IRAS ID
279229
Contact name
Paul Lorigan
Contact email
Sponsor organisation
Ultimovacs ASA
Eudract number
2019-002026-75
Duration of Study in the UK
2 years, 0 months, 20 days
Research summary
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. The UV1 vaccine consists of both sargramostim and UV1.
Nivolumab and ipilimumab work by boosting the body’s own immune system to attack the cancer cells. However, this does not work in all patients. We hope that by adding UV1 vaccination to nivolumab and ipilimumab more patients will benefit from the anticancer treatment. The UV1 vaccination functions by stimulating the immune system to produce T-cells, a type of cell used in the immune system, that bind to telomerase and interfere with its function. Telomerase is an enzyme essential to the growth and immortality of cancer cells and it is hoped that UV1’s interference with its activation will enable tumor cell killing in even otherwise highly dynamic tumors.
Approximately 44 patients will be randomized equally into 2 groups, to receive either treatment A: UV1 vaccination + nivolumab + ipilimumab for 73 days or treatment B: nivolumab + ipilimumab for 64 days. Participation in the study will last up to 27 months, depending on how long the patient remains on the study drugs. During the study there will be a Screening period lasting up to 28 days, followed by an Induction Period containing 8 study visits for treatment group A and 4 for treatment group B, lasting 73 or 64 days depending on treatment group. This is followed by a Follow-Up Period where the patients will be put on a maintenance therapy until the study closure or the study doctor decides to stop the therapy.
REC name
North West - Greater Manchester Central Research Ethics Committee
REC reference
20/NW/0216
Date of REC Opinion
13 Jul 2020
REC opinion
Further Information Favourable Opinion