PDE5 Inhibition Via Tadalafil to Enhance Anti-Tumor Mucin 1 (MUC1) Vaccine Efficacy in Patients With HNSCC

Phase 1 Completed 16 enrolled Donald T. Weed, MD, FACS

RandomizedParallel-groupDouble-blindTreatment

Summary

The investigators hypothesize that Tadalafil treatment, by lowering Myeloid Derived Suppressor Cells (MDSCs) and regulatory T cells (Tregs), can prime an antitumor immune response and promote a permissive environment that should increase the efficacy of anti-tumor vaccine in a setting of minimal residual disease.

Timeline

Start: 2016-04-25
Primary completion: 2019-06-02
Completion: 2021-06-08

Publications

Results Weed DT, Zilio S, Reis IM, Sargi Z, Abouyared M, Gomez-Fernandez CR, Civantos FJ, Rodriguez CP, Serafini P. The Reversal of Immune Exclusion Mediated by Tadalafil and an Anti-tumor Vaccine Also Induces PDL1 Upregulation in Recurrent Head and Neck Squamous Cell Carcinoma: Interim Analysis of a Phase I Clinical Trial. Front Immunol. 2019 May 31;10:1206. doi: 10.3389/fimmu.2019.01206. eCollection 2019.

Drugs

Evaluation	Drug	Modality	Dose	Route
Subject	Flublok	Vaccine	0.3 ml	Intramuscular
Subject	Hiltonol	Other / unclassified	0.3 ml	Intramuscular
Subject	Tadalafil	Small molecule	10 mg	Oral
Subject	Tadalafil	Small molecule	20 mg	Oral

PDE5 Inhibition Via Tadalafil to Enhance Anti-Tumor Mucin 1 (MUC1) Vaccine Efficacy in Patients With HNSCC

Summary

Timeline

Publications

Drugs

Indications