Squamous Cell Carcinoma of the Head and Neck (SCCHN)Phase 2NCT05057247
Duvelisib Plus Docetaxel In Recurrent/Metastatic HNSCC
A Phase 2 study testing Duvelisib and Docetaxel in people with Squamous Cell Carcinoma of the Head and Neck (SCCHN) and Recurrent Squamous Cell Carcinoma of the Head and Neck, run by Kartik Sehgal, MD at 1 site in United States.
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Squamous Cell Carcinoma of the Head and Neck (SCCHN), Recurrent Squamous Cell Carcinoma of the Head and Neck, Metastatic Head and Neck Cancer
- What is being tested?
- Duvelisib and Docetaxel
- Type of treatment
- Pill or oral medicine, Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 26 participants
- Where
- 1 siteUnited States
- Study dates
- 14 Oct 2021to 13 Jun 2024
- Phase
- Phase 2
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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).
Show all 21Show fewer
- 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
- serum creatinine ≤ 1.5x ULN OR creatinine clearance ≥ 60 mL/min/1.73 m2 for participants with creatinine levels above 1.5x ULN
- coagulation profile INR ≤ 1.5x ULN unless the participant is receiving an anticoagulant
- Baseline tumor measurements must be documented from imaging within 28 days prior to study registration.
- Female subjects of childbearing potential should have a negative urine or serum pregnancy test within 7 days of study registration. Female subjects of childbearing potential should have a negative urine or serum pregnancy test repeated within 72 hours prior to receiving the first dose of study medication. If the urine test is positive or cannot be confirmed as negative, a serum pregnancy test will be required.
- Female and male subjects of childbearing potential must agree to use an adequate method of contraception (hormonal or barrier method of birth control; abstinence) prior to study entry, for the duration of study participation, and 4 months after completion of stud drug administration. Contraception is required before starting the first dose of study medication through 120 days after the last dose of study medication. Note: Abstinence is acceptable if this is the usual lifestyle and preferred contraception for the subject.
- Be willing and able to provide written informed consent for the trial.
Who cannot join
- 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.
Show all 9Show fewer
- 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.
Trial locations and contacts
1 site in 1 country.
United States1 site
Dana Farber Cancer Institute
Boston, Massachusetts, 02115
About this study
Official title: A Phase II Study of Duvelisib Plus Docetaxel in PD-1 Inhibitor Experienced Patients With Incurable Head and Neck Squamous Cell Carcinoma
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
Read the 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
- Being tested
- Duvelisib, Docetaxel
- 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
- Medical subject headings
- Squamous Cell Carcinoma of Head and Neck, Head and Neck Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
DuvelisibDrug
Also called VS-0145
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.
DocetaxelDrug
Also called Taxotere
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
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Drug: Duvelisib; Drug: Docetaxel |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Median time on treatment was 2.3 months (range 0.7-21.9 months)
Secondary outcomes (5)
Median Overall Survival (OS)
OS based on the Kaplan-Meier method was defined as the time from registration to death due to any cause, or censored at date last known alive.
Measured: The median follow-up time was 6.5 months (range 0.7 - 26 months).
Median Progression Free Survival (PFS)
PFS based on the Kaplan-Meier method was defined as the time from registration to the earlier of progression or death due to any cause. Participants alive without disease progression are censored at date of last disease evaluation. Per RECIST 1.1 for target lesions: PD is at least a 20% increase in sum LD, taking as reference the smallest sum on study with at least 5 mm absolute increase. For non-target lesions, progression-free means no new lesions or unequivocal progression on existing non-target lesions or not evaluated.
Measured: Median follow-up time was 2.3 months (range 0.7-21.9 months)
Duration of Response (DOR)
DOR was measured from the time measurement criteria are met for CR or PR (whichever is first recorded) until the first date that recurrent or progressive disease is objectively documented (taking as reference for progressive disease the smallest measurements recorded since the treatment started. Per Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0) for target lesions and assessed by MRI: Complete Response (CR), Disappearance of all target lesions; Partial Response (PR), >=30% decrease in the sum of the longest diameter of target lesions; Overall Response (OR) = CR + PR.
Measured: 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
The number of participants who experienced the treatment-related adverse events per CTCAE 5.0 during the time of treatment.
Measured: 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
The QLQ H\&N35 incorporates seven multi-item scales that assess pain, swallowing, senses (taste and smell), speech, social eating, social contact and sexuality. There are also eleven single items. The score range from 0 to 100.
For all items and scales, high scores indicate more problems, so negative difference indicates better QoL (less problems) at C4D1 compared to C1D1.
Measured: Up to 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Sep 2021
- Study start14 Oct 2021
- Primary completion1 Oct 2023
- Study completion13 Jun 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Squamous Cell Carcinoma of the Head and Neck (SCCHN)Studies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 26 participants (actual)
Sponsor and investigators
- Lead sponsor
- Kartik Sehgal, MD
- Sponsor type
- University, hospital or other
- Collaborators
- Secura Bio, Inc.
- Responsible party
- Sponsor-investigator, Kartik Sehgal, MD, Dana-Farber Cancer Institute
- Investigators
- Kartik Sehgal, MD, Principal investigator, Dana-Farber Cancer Institute
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05057247
- Sponsor's protocol ID
- 21-393
- Status last verified
- Sep 2026
- First submitted
- 8 Sep 2021
- Last updated
- 29 Sep 2026
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- Yes: The Dana-Farber / Harvard Cancer Center encourages and supports the responsible and ethical sharing of data from clinical trials. De-identified participant data from the final research dataset used in the published manuscript may only be shared under the terms of a Data Use Agreement. Requests may be directed to Sponsor Investigator or designee. The protocol and statistical analysis plan will be made available on Clinicaltrials.gov only as required by federal regulation or as a condition of awards and agreements supporting the research.