Phase I Randomized, Double-blind, Placebo-controlled Study of Topical Resiquimod as an Adjuvant for NY-ESO1 Protein+Montanide Vaccination in Patients With Tumors That Often Express NY-ESO-1
There is no published data on the application of topical resiquimod in combination with an
antigen in Montanide, therefore, this study includes a 2-part design where Part I represents
a dose-escalation part with topical resiquimod in an open-label fashion. Part II represents
the randomized part.
In Part I, 2 cohorts are planned: If no dose-limiting toxicity (DLT) occurs by day 8 of the
last vaccination cycle in the last patient enrolled the first cohort, 3 additional patients
(cohort 2) will be enrolled. If no DLT occurs by day 8 of the last vaccination cycle in the
last patient enrolled the second cohort in Part I, the trial will proceed to Part II where
patients will be randomized.
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Factorial Assignment, Masking: Double Blind (Subject, Caregiver, Investigator), Primary Purpose: Treatment
The primary objectives of the study are to define the safety and immunogenicity of vaccination with NY-ESO-1 protein emulsified in Montanide® ISA-51 VG when given with or without the topical TLR 7/8 agonist resiquimod.
Blood samples are obtained at baseline, 1 week after each vaccination, and at follow-up 1visit.
Nina Bhardwaj, MD, PhD
NYU Langone Medical Center
United States: Food and Drug Administration
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