Spots Global Cancer Trial Database for PDE5 Inhibition Via Tadalafil to Enhance Anti-Tumor Mucin 1 (MUC1) Vaccine Efficacy in Patients With HNSCC

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Trial Identification

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

Official Title: PDE5 Inhibition Via Tadalafil (Cialis®) to Enhance Anti-Tumor MUC1 Vaccine Efficacy in Patients With Resectable, and Recurrent or Second Primary Head and Neck Squamous Cell Carcinoma (HNSCC): A Phase I/II Clinical Trial

Study ID: NCT02544880

Conditions

Head and Neck Squamous Cell Carcinoma

Head and Neck Cancer

Interventions

Tadalafil

Anti-MUC1 Vaccine

Anti-Influenza Vaccine

Tadalafil Placebo

Anti-MUC1 Vaccine Placebo

Standard of Care Treatment

Anti-Influenza Vaccine Placebo

Study Description

Brief 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.

Detailed Description: This study is halting accrual at the end of the phase 1 portion of the study as data from the phase I study suggest that an alternative approach for the phase 2 portion of the study be undertaken. A newly designed Phase II trial is being developed and will be submitted as a new study protocol.