Oslo, 10 April 2021: Ultimovacs ASA (“Ultimovacs”, ticker ULTI), announced that it is presenting a poster today on the trial design of its ongoing Phase II INITIUM clinical study evaluating nivolumab and ipilimumab in combination with the Company’s proprietary universal cancer vaccine, UV1, as first line treatment in patients with metastatic malignant melanoma, at the 2021 AACR Annual Meeting, held virtually from April 9 to April 14, 2021.
The poster, titled, “Nivolumab and ipilimumab +/- UV1 vaccine as 1st line treatment in patients with malignant melanoma (INITIUM-trial)”, details the INITUM study, a randomized, open label study investigating the efficacy and safety of UV1 vaccination in combination with nivolumab and ipilimumab as first line treatment in histologically confirmed unresectable metastatic melanoma patients. The INITIUM study is enrolling 154 patients, randomly assigned to the experimental arm or the control arm. Patients in the experimental arm will receive 8 UV1 vaccinations over 4 cycles of nivolumab and ipilimumab, whereas patients in the control arm will receive 4 cycles of nivolumab and ipilimumab without UV1 vaccination. In both arms, patients will start maintenance therapy with nivolumab after the last dose of induction therapy and will be followed until the end of the study. The primary outcome of the study is the Progression Free Survival (PFS) of patients in the experimental arm compared to patients in the control arm. Secondary outcomes include the comparison of Overall Survival (OS) and Objective Response Rate (ORR) between the groups.
Details of the presentation are as follows:
Title: Nivolumab and ipilimumab +/- UV1 vaccine as 1st line treatment in patients with malignant melanoma (INITIUM-trial) Session
Type: E-poster Session
Session Title: Phase II Clinical Trials in Progress
Abstract Number: CT23
The poster is available in Reports and Presentations