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

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.

Timeline

Start

2017-08-10

Primary completion

2019-07-30

Completion

2022-09-08

Publications

• Luginbuhl AJ, Johnson JM, Harshyne LA, Linnenbach AJ, Shukla SK, Alnemri A, Kumar G, Cognetti DM, Curry JM, Kotlov N, Antysheva Z, Degryse S, Mannion K, Gibson MK, Netterville J, Brown B, Axelrod R, Zinner R, Tuluc M, Gargano S, Leiby BE, Shimada A, Mahoney MG, Martinez-Outschoorn U, Rodeck U, Kim YJ, South AP, Argiris A. Tadalafil Enhances Immune Signatures in Response to Neoadjuvant Nivolumab in Resectable Head and Neck Squamous Cell Carcinoma. Clin Cancer Res. 2022 Mar 1;28(5):915-927. doi: 10.1158/1078-0432.CCR-21-1816.

Drugs

Indications