Ultimovacs ASA announced the completed recruitment of 21 patients in the exploratory single-arm study complementing the INITIUM trial. INITIUM (NCT04382664) is Ultimovacs' randomized Phase II trial investigating its universal cancer vaccine UV1 in combination with the checkpoint inhibitors ipilimumab and nivolumab in the treatment of patients with unresectable or metastatic malignant melanoma. The supplementary study was designed to elucidate and describe the mechanisms leading to improved clinical effects in patients treated with UV1 vaccination.

The study will provide in-depth data on the biological activity and mode of action of the T cells induced by the UV1 vaccination on top of ipilimumab and nIVolumab. The results from the research will help identify patients with vaccine-specific immune responses and evaluate the vaccine's impact on broadening the overall immune response. The data will also help assess the vaccine's effectiveness in enhancing responsiveness to checkpoint inhibitors in otherwise resistant patients.

Analyses from the supplementary study will be performed in parallel with the analyses from the randomized INITIUM study. The results from the supplementary study will not be included in the topline results from the INITIUM study.