NCT03993353

Tadalafil and Pembrolizumab in Recurrent or Metastatic Head and Neck Cancer

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

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 7 (actual)
• Sponsor: University of California, San Diego · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

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

Type	Name	Description
DRUG	Pembrolizumab	200 mg intravenously every 3 weeks
DRUG	Tadalafil	10 mg by mouth daily

Timeline

• Start date: 2020-04-07
• Primary completion: 2022-04-16
• Completion: 2024-01-09
• First posted: 2019-06-20
• Last updated: 2026-02-12
• Results posted: 2026-02-12

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated drug study