Dataset Information

Multicenter, double-blind, placebo-controlled trial of seviprotimut-L polyvalent melanoma vaccine in patients with post-resection melanoma at high risk of recurrence.

ABSTRACT:

Background

Most patients with advanced melanomas relapse after checkpoint blockade therapy. Thus, immunotherapies are needed that can be applied safely early, in the adjuvant setting. Seviprotimut-L is a vaccine containing human melanoma antigens, plus alum. To assess the efficacy of seviprotimut-L, the Melanoma Antigen Vaccine Immunotherapy Study (MAVIS) was initiated as a three-part multicenter, double-blind, placebo-controlled phase III trial. Results from part B1 are reported here.

Methods

Patients with AJCC V.7 stage IIB-III cutaneous melanoma after resection were randomized 2:1, with stage stratification (IIB/C, IIIA, IIIB/C), to seviprotimut-L 40 mcg or placebo. Recurrence-free survival (RFS) was the primary endpoint. For an hypothesized HR of 0.625, one-sided alpha of 0.10, and power 80%, target enrollment was 325 patients.

Results

For randomized patients (n=347), arms were well-balanced, and treatment-emergent adverse events were similar for seviprotimut-L and placebo. For the primary intent-to-treat endpoint of RFS, the estimated HR was 0.881 (95% CI: 0.629 to 1.233), with stratified logrank p=0.46. However, estimated HRs were not uniform over the stage randomized strata, with HRs (95% CIs) for stages IIB/IIC, IIIA, IIIB/IIIC of 0.67 (95% CI: 0.37 to 1.19), 0.72 (95% CI: 0.35 to 1.50), and 1.19 (95% CI: 0.72 to 1.97), respectively. In the stage IIB/IIC stratum, the effect on RFS was greatest for patients <60 years old (HR=0.324 (95% CI: 0.121 to 0.864)) and those with ulcerated primary melanomas (HR=0.493 (95% CI: 0.255 to 0.952)).

Conclusions

Seviprotimut-L is very well tolerated. Exploratory efficacy model estimation supports further study in stage IIB/IIC patients, especially younger patients and those with ulcerated melanomas.

Trial registration number

NCT01546571.

SUBMITTER: Slingluff CL

PROVIDER: S-EPMC8488725 | biostudies-literature | 2021 Oct

REPOSITORIES: biostudies-literature

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Publications

Multicenter, double-blind, placebo-controlled trial of seviprotimut-L polyvalent melanoma vaccine in patients with post-resection melanoma at high risk of recurrence.

Slingluff Craig L CL Lewis Karl D KD Andtbacka Robert R Hyngstrom John J Milhem Mohammed M Markovic Svetomir N SN Bowles Tawnya T Hamid Omid O Hernandez-Aya Leonel L Claveau Joel J Jang Sekwon S Philips Prejesh P Holtan Shernan G SG Shaheen Montaser F MF Curti Brendan B Schmidt William W Butler Marcus O MO Paramo Juan J Lutzky Jose J Padmanabhan Arvinda A Thomas Sajeve S Milton Daniel D Pecora Andrew A Sato Takami T Hsueh Eddy E Badarinath Suprith S Keech John J Kalmadi Sujith S Kumar Pallavi P Weber Robert R Levine Edward E Berger Adam A Bar Anna A Beck J Thaddeus JT Travers Jeffrey B JB Mihalcioiu Catalin C Gastman Brian B Beitsch Peter P Rapisuwon Suthee S Glaspy John J McCarron Edward C EC Gupta Vinay V Behl Deepti D Blumenstein Brent B Peterkin Joanna J JJ

Journal for immunotherapy of cancer 20211001 10

<h4>Background</h4>Most patients with advanced melanomas relapse after checkpoint blockade therapy. Thus, immunotherapies are needed that can be applied safely early, in the adjuvant setting. Seviprotimut-L is a vaccine containing human melanoma antigens, plus alum. To assess the efficacy of seviprotimut-L, the Melanoma Antigen Vaccine Immunotherapy Study (MAVIS) was initiated as a three-part multicenter, double-blind, placebo-controlled phase III trial. Results from part B1 are reported here.<h ...[more]

PMID: 34599031

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Dataset Information

Multicenter, double-blind, placebo-controlled trial of seviprotimut-L polyvalent melanoma vaccine in patients with post-resection melanoma at high risk of recurrence.

Background

Methods

Results

Conclusions

Trial registration number

Publications

Multicenter, double-blind, placebo-controlled trial of seviprotimut-L polyvalent melanoma vaccine in patients with post-resection melanoma at high risk of recurrence.

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