Duvelisib Plus Docetaxel In Recurrent/Metastatic HNSCC

NCT05057247 | Completed Phase 2 Results DMC FDA Drug

• 1 other identifier: 21-393
• Study Type: interventional
• Target: 26
• Locations: 1 country
• Sites: 1

Brief 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

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

Keywords

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

Outcome Measures

Primary Outcomes (1)

• Best Overall Response (BOR) Rate

  BOR rate was defined as the proportion of participants that experienced complete response (CR) or partial response (PR) on treatment based on RECIST 1.1 criteria. Per RECIST 1.1 for target lesions: CR is complete disappearance of all target lesions and PR is at least a 30% decrease in the sum of longest diameter (LD) of target lesions, taking as reference baseline sum LD. PR or better overall response assumes at a minimum incomplete response/stable disease (SD) for the evaluation of non-target lesions and absence of new lesions.

  Median time on treatment was 2.3 months (range 0.7-21.9 months)

Secondary Outcomes (5)

• Median Overall Survival (OS)

  The median follow-up time was 6.5 months (range 0.7 - 26 months).

• Median Progression Free Survival (PFS)

  Median follow-up time was 2.3 months (range 0.7-21.9 months)

• Duration of Response (DOR)

  Median follow-up time was 2.3 months (range 0.7-21.9 months)

• Number of Participants With Treatment Related Adverse Events Per CTCAE 5.0

  Median follow-up time was 2.3 months (range 0.7-21.9 months)

• Change of QLQ H&N 35 From Cycle 1 to Cycle 4

  Up to 3 months

Study Arms (1)

Duvelisib plus Docetaxel chemotherapy

EXPERIMENTAL

Participants will receive duvelisib by mouth twice daily,dosage per protocol continuously (days 1-21 of a 21-day cycle) with a 7-day lead-in planned prior to the start of taxane therapy. Docetaxel at via IV will be delivered on day 1 of each 21-day cycle. Treatment will continue for 24-months or until unacceptable toxicity, progression, or death.

Drug: Duvelisib; Drug: Docetaxel

Interventions

Duvelisib DRUG

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.

Also known as: VS-0145

Duvelisib plus Docetaxel chemotherapy

Docetaxel DRUG

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

Also known as: Taxotere

Duvelisib plus Docetaxel chemotherapy

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Participants must meet the following criteria on screening examination to be eligible to participate in the study:
• Participants must have histologically confirmed squamous cell carcinoma of the head and neck (SCCHN) with evidence of recurrent, metastatic (R/M) or advanced, incurable disease from any mucosal subsite including oral cavity, oropharynx, larynx, hypopharynx, nasal cavity, and the paranasal sinuses.
• Participants must have at least one RECIST v1.1 measurable lesion, as defined as at least one lesion that can be accurately measured in at least one dimension (longest diameter to be recorded for non-nodal lesions and short axis for nodal lesions) ≥1 cm with CT scans or MR imaging.
• Must have had at least 1, but no more than 2, prior lines of prior systemic therapy for R/M SCCHN; one of these lines should have included PD-1/L1 blockade
• Platinum-based therapy as part of definitive/adjuvant or curative-intent treatment can count as 1 prior line of therapy if the subject progressed within 6 months of receiving therapy.
• At least 2 weeks must have elapsed since the end of prior chemotherapy, biological agents (3 weeks for anti-cancer monoclonal antibody containing regimens) or any investigational drug product, with adequate recovery of treatment-related toxicity to NCI CTCAE Version 5.0 grade ≤1 (or tolerable grade 2) or back to baseline (except for alopecia or peripheral neuropathy).
• Be ≥18 years of age on the day of signing informed consent.
• Must provide prior data on tumor PD-L1 expression status and HPV status, if available
• Have a performance status of 0 or 1 on the ECOG Performance Scale
• Participants must have adequate organ and marrow function as defined below (within 14 days prior to study registration):
• absolute neutrophil count ≥ 1,000/mcL
• hemoglobin ≥ 9 g/dL
• platelets ≥ 100,000/mcL
• total bilirubin ≤ upper limit of normal (ULN)
• AST(SGOT)/ALT(SGPT) ≤ 2.5x institutional ULN (or ≤ 1.5x institutional ULN if concomitant with alkaline phosphatase \>2.5x institutional ULN) or ≤ 5x ULN for those with liver metastases

You may not qualify if:

• Participants who exhibit any of the following conditions at screening will not be eligible for admission into the study.
• Have been previously treated with 3 or more lines of systemic therapy for R/M SCCHN.
• \-- Have received treatment with a prior PI3K pathway inhibitor
• Have received radiation therapy (RT) within 14 days of the first dose of duvelisib on study.
• Participant has known active central nervous system (CNS) metastases and/or carcinomatous meningitis. Subjects with previously treated brain metastases may participate provided they are stable (without evidence of progression by imaging and off systemic steroids for at least 4 weeks prior to the first dose of study treatment), and have no evidence of new or enlarging brain metastases. This exception does not include carcinomatous meningitis which is excluded regardless of clinical stability, because of the poor prognosis and progressive neurologic dysfunction that would confound the evaluation of neurologic and other adverse events.
• Concurrent administration of other cancer specific therapy or investigational agents during the course of this study.
• Uncontrolled intercurrent illness including but not limited to ongoing or active infection; evidence of symptomatic congestive heart failure, unstable angina pectoris, stroke, or ventricular arrhythmia within 6 months of enrollment.
• Have received a live or live attenuated vaccine within 4 weeks of the first dose of duvelisib.
• Have received medications or consumed foods that are strong inhibitors or inducers of cytochrome P450 (CYP3A) within 2 weeks of, or while on, duvelisib.

Sponsors & Collaborators

• Glenn J. Hanna: lead
• Secura Bio, Inc.: collaborator

Study Sites (1)

Dana Farber Cancer Institute

Boston, Massachusetts, 02115, United States

Location

MeSH Terms

Conditions

Squamous Cell Carcinoma of Head and Neck; Head and Neck Neoplasms

Interventions

duvelisib; Docetaxel

Condition Hierarchy (Ancestors)

Carcinoma, Squamous Cell; Carcinoma; Neoplasms, Glandular and Epithelial; Neoplasms by Histologic Type; Neoplasms; Neoplasms by Site

Intervention Hierarchy (Ancestors)

Taxoids; Cyclodecanes; Cycloparaffins; Hydrocarbons, Alicyclic; Hydrocarbons, Cyclic; Hydrocarbons; Organic Chemicals; Diterpenes; Terpenes

Results Point of Contact

• Title: Glenn J. Hanna, M.D.
• Organization: Dana-Farber Cancer Institute

glenn_hanna@dfci.harvard.edu

617-632-309

Study Officials

• Glenn J. Hanna, MD

  Dana-Farber Cancer Institute

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Sponsor Investigator

Study Record Dates

• First Submitted: September 8, 2021
• First Posted: September 27, 2021
• Study Start: October 14, 2021
• Primary Completion: October 1, 2023
• Study Completion: June 13, 2024
• Last Updated: October 31, 2025
• Results First Posted: March 5, 2025

Record last verified: 2025-10

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP
• Time Frame: Data can be shared no earlier than 1 year following the date of publication
• Access Criteria: Contact the Belfer Office for Dana-Farber Innovations (BODFI) at innovation@dfci.harvard.edu

Locations

US (1)