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MELANOMA; Adjuvant; Stage 2B/C or 3; \"MAVIS\"

A multicenter, double-blind, placebo-controlled, adaptive phase 3 trial of POL-103A polyvalent melanoma vaccine in post-resection melanoma patients with a high risk of recurrence

Title
Polynoma 103A-301
Study Title

A multicenter, double-blind, placebo-controlled, adaptive phase 3 trial of POL-103A polyvalent melanoma vaccine in post-resection melanoma patients with a high risk of recurrence

Site Link
Malignancy
Melanoma, Early Melanoma
Stage
Disease Setting
Adjuvant
Line Of Therapy
N/A
Investigational Agent
Seviprotimut-L
Drug Class
Polyvalent Melanoma Vaccine
PI
Ari VanderWalde, MD
Sponsor
Polynoma
Phase
Status
Key Eligibility Criteria
Key Eligibility Criteria Details

Stage IIB, IIC, or III Melanoma
Last definitive resection within 90 days of first dose
Complete resection of all known disease
ECOG PS 0-1
Either known BRAF status or 10 unstained slides for BRAF testing
No adjuvant therapy except surgery/radiation, except-
May have had interferon if no longer than 7 days
No use of chronic steroids

Objective

Primary- RFS; Secondary- OS

Assessment Frequency
_
Assessment Frequency 2
_



Assessment Frequency Link
Path
Cutaneous (not mucosal or ocular)
Dosing Frequency

Leviprotimut 0.2 mL injection into both forearms and both thighs q2 weeks x4 doses, then qmonth x6 months, then q3 months until 24 months

Control Agents
Placebo injection
Study Protocol
Randomized
Yes
X