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 Trial1

Principal Investigators: Donald T. Weed, MD, FACS, University of Miami

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Description: For this randomized, phase 1/2 study, researchers are evaluating whether tadalafil improves the response to vaccination among patients with recurrent head and neck squamous cell carcinoma. Patients in whom a second primary tumor is detected are also eligible.

Tadalafil lowers myeloid derived suppressor cells and regulatory T cells, which may improve the immunoresponse among vaccine-treated patients with minimal residual disease.

Patients will be randomized to 1 of 3 groups: in the first, patients will receive tadalafil, an anti-MUC1 vaccine, and an anti-influenza vaccine, in the second, patients will receive tadalafil and a placebo vaccine, and in the third patient will receive tadalafil placebo and both an anti-MUC1 vaccine and an anti-influenza vaccine.

There will also be a non-randomized group in which eligible patients are unwilling to receive the experimental treatment. These patients will undergo standard resection and will be followed for recurrence.

The primary phase 1 outcomes include toxicity; the primary phase 2 outcomes include tumor-specific immune response. Secondary outcomes include recurrence-free survival.

For more study information, including inclusion and exclusion criteria, study locations, and contact information, visit https://clinicaltrials.gov/ct2/show/NCT02544880.

Status: This study is open and recruiting patients as of April 11, 2017.


  1. Clinicaltrials.gov. PDE5 inhibition via tadalafil to enhance anti-tumor mucin 1 (MUC1) vaccine efficacy in patients with HNSCC. NCT02544880. https://clinicaltrials.gov/ct2/show/NCT02544880. Accessed April 11, 2017.