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

Craig L Slingluff; Karl D Lewis; Robert AndtbackaJohn HyngstromMohammed MilhemSvetomir N MarkovicTawnya BowlesOmid HamidLeonel Hernandez-AyaJoel ClaveauSekwon JangPrejesh PhilipsShernan G HoltanMontaser F ShaheenBrendan CurtiWilliam SchmidtMarcus O ButlerJuan ParamoJose LutzkyArvinda PadmanabhanSajeve ThomasDaniel MiltonAndrew PecoraTakami SatoEddy HsuehSuprith BadarinathJohn KeechSujith KalmadiPallavi KumarRobert WeberEdward LevineAdam BergerAnna BarJ Thaddeus BeckJeffrey B TraversCatalin MihalcioiuBrian GastmanPeter BeitschSuthee RapisuwonJohn GlaspyEdward C McCarronVinay GuptaDeepti BehlBrent BlumensteinJoanna J Peterkin

首页> 外文期刊>journal for immunotherapy of cancer >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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Multicenter, double-blind, placebo-controlled trial of seviprotimut-L polyvalent melanoma vaccine in patients with post-resection melanoma at high risk of recurrence

机译：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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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 .

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《journal for immunotherapy of cancer》 |2021年第10期|1-12|共12页
作者
Craig L Slingluff; Karl D Lewis; Robert AndtbackaJohn HyngstromMohammed MilhemSvetomir N MarkovicTawnya BowlesOmid HamidLeonel Hernandez-AyaJoel ClaveauSekwon JangPrejesh PhilipsShernan G HoltanMontaser F ShaheenBrendan CurtiWilliam SchmidtMarcus O ButlerJuan ParamoJose LutzkyArvinda PadmanabhanSajeve ThomasDaniel MiltonAndrew PecoraTakami SatoEddy HsuehSuprith BadarinathJohn KeechSujith KalmadiPallavi KumarRobert WeberEdward LevineAdam BergerAnna BarJ Thaddeus BeckJeffrey B TraversCatalin MihalcioiuBrian GastmanPeter BeitschSuthee RapisuwonJohn GlaspyEdward C McCarronVinay GuptaDeepti BehlBrent BlumensteinJoanna J Peterkin;
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Department of Surgery, University of Virginia School of Medicine;

University of Colorado - Anschutz Medical Campus;

Huntsman Cancer Institute Cancer HospitalThe University of Iowa Hospitals and ClinicsMayo Clinic RochesterIntermountain Medical CenterCedars-Sinai Medical Center Angeles Clinic and Research InstituteDepartment of Medicine, Washington University School of Medicine in Saint LouisCHU de Quebec-Universite LavalDepartment of Medical Oncology, Inova Health SystemUniversity of LouisvilleUniversity of Minnesota Academic Health CenterUniversity of Arizona Medical Center - University CampusEarle A Chiles Research Institute, Providence Portland Medical CenterBend Memorial ClinicPrincess Margaret Hospital Cancer CentreMount Sinai Medical CenterDepartment of Oncology, Sylvester Comprehensive Cancer CenterBaptist Health LexingtonMD Anderson Cancer Center OrlandoInvestigative Clinical Research of IndianaDepartment of Oncology, John Theurer Cancer CenterDepartment of Medical Oncology, Thomas Jefferson UniversitySt. Louis University HospitalCancer Specialists of North FloridaMulticare Institute for Research and InnovationIronwood Cancer and Research CentersHarry and Jeanette Weinberg Cancer Institute at Franklin SquareSt. Mary's Hospital and Medical CenterWake Forest School of MedicineRutgers Cancer Institute of New JerseyOregon Health & Science UniversityDepartment of Medical Oncology, Highlands Oncology GroupPremier Health Partners IncRoyal Victoria HospitalDepartment of Plastic Surgery, Cleveland ClinicCancer SolutionsDepartment of Oncology, Georgetown University Medical CenterDepartment of Hematology/Oncology, MedStar Washington Hospital CenterUniversity of California Los Angeles, Los AngelesMedStar Franklin Square Medical CenterSutter Institute for Medical ResearchTrial Architecture Consulting, Chevy ChasePolynoma;

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active; immunotherapy; melanoma; vaccination;

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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