NCT03238365

Window of Opportunity Trial of Nivolumab and Tadalafil in Patients With Squamous Cell Carcinoma of the Head and Neck

• Status: Completed
• Phase: EARLY_Phase 1
• Study type: Interventional
• Enrollment: 50 (actual)
• Sponsor: Sidney Kimmel Comprehensive Cancer Center at Thomas Jefferson University · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

This randomized pilot early phase I trial studies how well nivolumab with or without tadalafil work in treating patients with head and neck squamous cell carcinoma that has come back and can be removed by surgery. Monoclonal antibodies, such as nivolumab, may interfere with the ability of tumor cells to grow and spread. Tadalafil may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth. Giving nivolumab and tadalafil may work better in treating patients head and neck squamous cell carcinoma.

Detailed description

PRIMARY OBJECTIVES: I. To investigate whether adding the PDE5 inhibitor, tadalafil, to nivolumab therapy affects intratumoral and systemic anti-tumor immunity. SECONDARY OBJECTIVES: I. Characterize the combined effects of nivolumab and tadalafil on safety, exosome composition and function, the composition of intratumoral immune cell populations, wound healing, and tumor radiographic response.

Conditions

• Lip, Oral Cavity and Pharynx
• Larynx

Interventions

Type	Name	Description
BIOLOGICAL	Nivolumab	Given IV
DRUG	Tadalafil	Given orally
PROCEDURE	Therapeutic Conventional Surgery	Undergo surgery

Timeline

• Start date: 2017-08-10
• Primary completion: 2019-07-30
• Completion: 2022-09-08
• First posted: 2017-08-03
• Last updated: 2025-04-29

Locations

2 sites across 1 country: United States

Regulatory

• FDA-regulated drug study