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Clinical Trial Summary

This trial that is investigating a medication called duvelisib in combination with docetaxel for the treatment of squamous cell carcinoma of the head and neck (SCCHN) that has returned or spread outside the head and neck area. The names of the study drugs involved in this study are: - Duvelisib (PI3K inhibitor) - Docetaxel chemotherapy

Clinical Trial Description

This multicenter, phase II open-label, single-arm trial will enroll participants with recurrent or metastatic (R/M), incurable squamous cell carcinoma of the head and neck (SCCHN) who have failed or discontinued PD-1 blockade in the first-line (1L) advanced disease setting, regardless of human papillomavirus (HPV) and smoking status, or PI3K pathway alteration status. This research study involves the oral (taken by mouth) agent duvelisib with the intravenous (IV) chemotherapy agent docetaxel. The names of the study drugs involved in this study are: - Duvelisib (PI3K inhibitor) - Docetaxel chemotherapy The research study procedures include screening for eligibility and study treatment including evaluations and follow up visits. Participants will receive study treatment for up to 2 years and will be followed for 3 years. It is expected that about 30 people will take part in this research. This research study is a Phase II clinical trial. Phase II clinical trials test the safety and effectiveness of an investigational drug (duvelisib) to learn whether it works in treating a specific disease. "Investigational" means that the drug is being studied. The U.S. Food and Drug Administration (FDA) has not approved duvelisib for this specific disease but has approved it for other uses (such as certain types of blood cancers). The FDA has approved docetaxel as a treatment option for head and neck cancer, as well as other cancer types. ;

Study Design

Related Conditions & MeSH terms

NCT number NCT05057247
Study type Interventional
Source Dana-Farber Cancer Institute
Contact Glenn J. Hanna, MD
Phone (617) 632-3090
Email [email protected]
Status Not yet recruiting
Phase Phase 2
Start date January 2022
Completion date September 1, 2023

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