The telomerase vaccine UV1 combined with ipilimumab and nivolumab versus ipilimumab and nivolumab in advanced melanoma (INITIUM): A randomized open-label phase 2 study

Dec 9, 2025European journal of cancer (Oxford, England : 1990)

Adding the UV1 telomerase vaccine to ipilimumab and nivolumab in advanced melanoma: A phase 2 randomized study

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Abstract

The projected median progression-free survival was 34.3 months with ipilimumab-nivolumab-UV1 and 38.4 months with ipilimumab-nivolumab.

At 12 months, progression-free survival was 57% for both treatment groups.
Objective response rates were similar between the two groups, at approximately 59%.
Median overall survival was not reached for either treatment arm.
Grade > 3 treatment-emergent adverse events occurred in about 64.5% of patients receiving ipilimumab-nivolumab-UV1 and 65.4% in the ipilimumab-nivolumab group.
The addition of UV1 did not lead to improved efficacy compared to ipilimumab-nivolumab alone.

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PURPOSE: Immune checkpoint inhibitor (ICI) combinations have improved outcomes in patients with advanced melanoma; however, long term survival remains poor. The addition of therapeutic cancer vaccines to ICI combinations represents a promising strategy to enhance efficacy.

METHODS: In this phase 2, randomized, open-label trial, 156 patients with unresectable or metastatic melanoma were randomized 1:1 to receive 4 cycles of ipilimumab 3mg/kg and nivolumab 1mg/kg with or without UV1, a telomerase-targeted therapeutic cancer vaccine, followed by maintenance nivolumab 480 mg every 4 weeks. The primary endpoint was progression-free survival (PFS) based on blinded independent central review. Secondary endpoints included overall survival (OS), response assessments, and safety.

RESULTS: At a minimum follow-up of 18 months, the projected median PFS was 34.3 months (95 % confidence interval [CI], 7.95 to NR) with ipilimumab-nivolumab-UV1 and 38.4 months (95 % CI, 8.15-38.37) with ipilimumab-nivolumab (hazard ratio, 0.95 [95 % CI, 0.59-1.55]). PFS at 12 months was 57 % (95 % CI, 45.0-68.1) and 57 % (95 % CI, 44.6-67.0) in the ipilimumab-nivolumab-UV1 and ipilimumab-nivolumab arms, respectively. Objective response rates were 59.7 % (ipilimumab-nivolumab-UV1) and 59.2 % (ipilimumab-nivolumab; odds ratio, 1.12; 95 % CI, 0.58-2.16). Median overall survival was not reached in either arm (hazard ratio, 1.15 [95 % CI, 0.60-2.20]). Grade > 3 treatment-emergent adverse events were reported in 64.5 % and 65.4 % of patients respectively.

CONCLUSION: For patients with treatment naïve advanced melanoma, the addition of UV1 to ipilimumab-nivolumab did not result in improved efficacy compared with ipilimumab-nivolumab alone.

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The telomerase vaccine UV1 combined with ipilimumab and nivolumab versus ipilimumab and nivolumab in advanced melanoma (INITIUM): A randomized open-label phase 2 study

Abstract

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