Pilot clinical trial of neoadjuvant toll-like receptor 7 agonist (Imiquimod) immunotherapy in early-stage oral squamous cell carcinoma

Pilot clinical trial of neoadjuvant toll-like receptor 7 agonist (Imiquimod) immunotherapy in early-stage oral squamous cell carcinoma

BackgroundThere is no neoadjuvant immunotherapy for early-stage oral cancer patients. We report a single-arm, open-label, pilot clinical trial assessing the efficacy and safety of topical toll-like receptor-7 (TLR-7) agonist, imiquimod, utilized in a neoadjuvant setting in early-stage oral squamous...

Full description

Saved in:
Bibliographic Details
Main Authors: Angela J. Yoon, Richard D. Carvajal, Evan M. Graboyes, John M. Kaczmar, William G. Albergotti, Alexandra E. Kejner, Scott H. Troob, Elizabeth Philipone, Jean-Sebastien Anoma, Kent E. Armeson, Elizabeth G. Hill, Mary S. Richardson, Tina R. Woods, Bhishamjit S. Chera, Farzad Nourollah-Zadeh, Byung J. Lee, Subramanya Pandruvada, Antonis Kourtidis, Christina Kingsley, Elizabeth C. O’Quinn, Stephanie Mills, Victoria C. Jordan, Mike Spencer, Danielle Fails, Trevor D. McKee, Mark Zaidi, Alan Brisendine, Shane Horn, Shikhar Mehrotra, Besim Ogretmen, Jason G. Newman
Format: Article
Language:English
Published: Frontiers Media S.A. 2025-01-01
Series:Frontiers in Immunology
Subjects:
oral cancer
neoadjuvant clinical trial
toll-like 7 receptor agonist
imiquimod
immunotherapy
Online Access:https://www.frontiersin.org/articles/10.3389/fimmu.2025.1530262/full
Tags: Add Tag
No Tags, Be the first to tag this record!
Description
Summary:BackgroundThere is no neoadjuvant immunotherapy for early-stage oral cancer patients. We report a single-arm, open-label, pilot clinical trial assessing the efficacy and safety of topical toll-like receptor-7 (TLR-7) agonist, imiquimod, utilized in a neoadjuvant setting in early-stage oral squamous cell carcinoma (OSCC).MethodsThe primary endpoint is reduction in tumor cell counts assessed by quantitative multiplex immunofluorescence and the immune-related pathologic response. The secondary endpoint is safety.Results60% of patients experienced a 50% reduction or greater in tumor cell count post-treatment (95% CI = 32% to 84%). Similarly, 60% of patients had immune-related major pathologic response (irMPR) with two complete pathologic responses, and 40% had partial response (PR) with the percent residual viable tumor ranging from 25% to 65%. An increase in functional helper and cytotoxic T-cells significantly contributed to a reduction in tumor (R=0.54 and 0.55, respectively). The treatment was well tolerated with the application site mucositis being the most common adverse event (grades 1-3), and no grade 4 life-threatening event. The median follow-up time was 17 months (95% CI = 16 months - not reached), and one-year recurrence-free survival was 93% of evaluable patients.ConclusionNeoadjuvant imiquimod immunotherapy could be safe and promising regimen for early-stage oral cancer.Trial registrationClinicalTrials.gov, Identifier NCT04883645.
ISSN:1664-3224

Similar Items