Oral Decitabine (ASTX727) and Durvalumab in Recurrent and/or Metastatic Head and Neck Cancer Patients

Summary

This is a non-randomized, open-label, Phase Ib study to assess the safety and efficacy of a DNA methyltransferase inhibitor and immune checkpoint inhibitor(s) (durvalumab and/or tremelimumab) combination therapy in the treatment of patients with recurrent and/or metastatic squamous cell carcinoma of the head and neck (SCCHN) who have progressed during or after treatment with anti-PD-1, anti-PD-L1, or anti-CTLA-4 monotherapy for recurrent and/or metastatic disease. The clinical trial is studying drugs that can boost the participant's immune system against the cancer cells as a possible treatment for head and neck cancer. The study interventions involved in this study are: * Oral Decitabine (ASTX 727) and 5' Azacytidine * Durvalumab (MEDI4736) and Tremelimumab

Timeline

Start

2017-03-20

Primary completion

2024-09-24

Completion

2024-09-24

Publications

• Results Qin T, Mattox AK, Campbell JS, Park JC, Shin KY, Li S, Sadow PM, Faquin WC, Micevic G, Daniels AJ, Haddad R, Garris CS, Pittet MJ, Mempel TR, ONeill A, Sartor MA, Pai SI. Epigenetic therapy sensitizes anti-PD-1 refractory head and neck cancers to immunotherapy rechallenge. J Clin Invest. 2025 Mar 17;135(6):e181671. doi: 10.1172/JCI181671.

Drugs

Indications