NCT05057247

Duvelisib Plus Docetaxel In Recurrent/Metastatic HNSCC

A Phase II Study of Duvelisib Plus Docetaxel in PD-1 Inhibitor Experienced Patients With Incurable Head and Neck Squamous Cell Carcinoma

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 26 (actual)
• Sponsor: Glenn J. Hanna · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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

Detailed 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.

Conditions

• Squamous Cell Carcinoma of the Head and Neck (SCCHN)
• Recurrent Squamous Cell Carcinoma of the Head and Neck
• Metastatic Head and Neck Cancer
• Advanced Head and Neck Cancer
• Advanced Head and Neck Squamous Cell Carcinoma

Interventions

Type	Name	Description
DRUG	Duvelisib	Duvelisib capsules should be swallowed whole with a glass of water (approximately 8 ounces). Advise patients not to open, break, or chew the capsules. Duvelisib may be administered without regard to meals; however, subjects should avoid grapefruit and grapefruit juice while on duvelisib. continue for up to 24 months.
DRUG	Docetaxel	Docetaxel chemotherapy once every 21 days (by intravenous infusion) over about 30- 60 minutes at each visit. This will continue for up to 24 months

Timeline

• Start date: 2021-10-14
• Primary completion: 2023-10-01
• Completion: 2024-06-13
• First posted: 2021-09-27
• Last updated: 2025-10-31
• Results posted: 2025-03-05

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated drug study