Ultimovacs Presents the INITIUM Study Design as a Trial-in-Progress Poster at AACR Annual Meeting 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 INITIUM 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:
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Title: |
Nivolumab and ipilimumab +/- UV1 vaccine as 1st line treatment in patients with malignant melanoma (INITIUM-trial) |
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Session Type: |
E-poster Session |
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Session Title: |
Phase II Clinical Trials in Progress |
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Abstract Number: |
CT23 |
The poster is available on Ultimovacs’ corporate website at www.ultimovacs.com.
About Ultimovacs
Ultimovacs seeks to become a leader in developing immune-stimulatory vaccines to treat a broad range of cancers. Ultimovacs’ lead universal cancer vaccine candidate UV1 leverages the high prevalence of the human telomerase (hTERT) to be effective across the dynamic stages of the tumor’s growth and its microenvironment. By directing the immune system to hTERT antigens that are present in over 80% of all cancers, UV1 drives CD4 helper T cells to the tumor with the goal of activating an immune system cascade to increase anti-tumor responses. Ultimovacs’ strategy is to clinically demonstrate UV1’s impact in many cancer types and in combination with other immunotherapies. The Company will expand its pipeline using its novel TET-platform, which is an innovative vaccine technology that can generate multiple vaccine candidates designed to achieve increased T cell responses to a broad range of target antigens.
For further information, please see www.ultimovacs.com.
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