Study of a Melanoma Vaccine in Stage IIb, IIc, and III Melanoma Patients

Summary

The purpose of this study is to determine how safe and how well POL-103A works in preventing the relapse of melanoma after patients who have undergone surgery.

Timeline

Start

2012-05-01

Primary completion

2021-04-29

Completion

2021-06-30

Outcome

Missed primary endpoint

Stopped: “After interim analysis the study was halted to redesign a pivotal trial.”

paper 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. PMID 34599031 ↗

Publications

• Slingluff CL, Lewis KD, Andtbacka R, Hyngstrom J, Milhem M, Markovic SN, Bowles T, Hamid O, Hernandez-Aya L, Claveau J, Jang S, Philips P, Holtan SG, Shaheen MF, Curti B, Schmidt W, Butler MO, Paramo J, Lutzky J, Padmanabhan A, Thomas S, Milton D, Pecora A, Sato T, Hsueh E, Badarinath S, Keech J, Kalmadi S, Kumar P, Weber R, Levine E, Berger A, Bar A, Beck JT, Travers JB, Mihalcioiu C, Gastman B, Beitsch P, Rapisuwon S, Glaspy J, McCarron EC, Gupta V, Behl D, Blumenstein B, Peterkin JJ. Multicenter, double-blind, placebo-controlled trial of seviprotimut-L polyvalent melanoma vaccine in patients with post-resection melanoma at high risk of recurrence. J Immunother Cancer. 2021 Oct;9(10):e003272. doi: 10.1136/jitc-2021-003272.

Drugs

Evaluation	Drug	Modality	Dose	Route
Subject	SEVIPROTIMUT-L	Unknown	40 ug	Other

Indications