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

Conditions

• Larynx
• Lip, Oral Cavity and Pharynx

Eligibility Criteria

Sex

ALL

Age

18 Years - N/A

Healthy Volunteers

Not accepted

Interventions

• Nivolumab — BIOLOGICAL
  Given IV
• Tadalafil — DRUG
  Given orally
• Therapeutic Conventional Surgery — PROCEDURE
  Undergo surgery

Study Details

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.

Key Dates

Start date

Aug 10, 2017

Status verified

Apr 2025

Primary completion

Jul 30, 2019

Completion

Sep 8, 2022

Study Design

Enrollment

50 participants (actual)

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Arms

• Active Comparator: Arm I (nivolumab)
  Patients receive nivolumab IV over 60 minutes on days 3 and 17 and undergo surgery on day 31.
• Experimental: Arm II (nivolumab, tadalafil)
  Patients receive nivolumab IV over 60 minutes on days 3 and 17 and tadalafil PO QD on days 3-31. Patients then undergo surgery on day 31.

Primary Outcome Measure

Change in immune cell polarization (Th1/Th2; M1/M2) in peripheral blood and tumor specimens using multiplex cytokine analysis [ Time Frame: Baseline up to day 31 of treatment ]

Locations (2)

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