Spots Global Cancer Trial Database for Tadalafil and Pembrolizumab in Recurrent or Metastatic Head and Neck Cancer

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Trial Identification

Brief Title: Tadalafil and Pembrolizumab in Recurrent or Metastatic Head and Neck Cancer

Official Title: A Phase II Study of Tadalafil and Pembrolizumab in Recurrent or Metastatic Head and Neck Squamous Cell Carcinoma

Study ID: NCT03993353

Conditions

Head and Neck Cancer

Head and Neck Squamous Cell Carcinoma

Head and Neck Carcinoma

Head and Neck Cancer Stage III

Head and Neck Cancer Stage IV

Head and Neck Cancer Metastatic

Cancer

Cancer of Esophagus

Cancer, Metastatic

Cancer of Head and Neck

Cancer of Mouth

Cancer of Neck

Interventions

Pembrolizumab

Tadalafil

Study Description

Brief Summary: This study will examine the combination of pembrolizumab and tadalafil for safety and efficacy in advanced head and neck cancer.

Detailed Description: Immune competent animal models of HNSCC demonstrate that combination PDE-5 inhibitor (tadalafil) and PD-1 inhibitor therapy is more effective than either therapy alone based on the concept of targeting multiple immune repressive abnormalities simultaneously (PD-1 checkpoint and myeloid suppressive pathways). This trial will test the hypothesis that combination PD-1 inhibition and PDE-5 inhibition can be safely co-administered, and secondarily test the hypothesis that the combination of both therapies will be more effective than PD-1 inhibition alone in recurrent/metastatic HNSCC.