Duvelisib Plus Docetaxel In Recurrent/Metastatic HNSCC (NCT05057247) | Clinical Trial Compass
CompletedPhase 2
Duvelisib Plus Docetaxel In Recurrent/Metastatic HNSCC
United States26 participantsStarted 2021-10-14
Plain-language 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
Who can participate
Age range18 Years
SexALL
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Inclusion Criteria:
* 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 c…
What they're measuring
1
Best Overall Response (BOR) Rate
Timeframe: Median time on treatment was 2.3 months (range 0.7-21.9 months)