Activity and Safety of Danvatirsen and Pembrolizumab in HNSCC
18 Years and older, Male and Female
FLM-6774-201 (primary)
NCI-2023-08785
Summary
Open-label, Phase II, randomized, controlled study evaluating the efficacy and safety of
danvatirsen in combination with pembrolizumab compared with pembrolizumab alone as
first-line treatment of patients with recurrent/metastatic (R/M) HNSCC. Two-thirds of
patients will be randomized to receive danvatirsen and pembrolizumab and one-third will
be randomized to receive pembrolizumab alone.
Objectives
This is a multicenter, open-label, Phase II, randomized, controlled study to determine
the efficacy, safety, and other indicators of clinical and biological activity of the
combination of danvatirsen and pembrolizumab as first-line treatment for R/M HNSCC.
After providing informed consent, patients will be assessed for eligibility during the
screening phase of the study. All patients must be willing and able to provide a formalin
fixed paraffin-embedded (FFPE) archival or fresh tumor sample collected during the
screening period; a fresh biopsy is preferred if safe and feasible to obtain and
consented to by the patient. Following the screening period, eligible patients will be
randomized in a 2:1 ratio to danvatirsen + pembrolizumab or pembrolizumab monotherapy,
respectively. Patients will receive treatment in 21-day cycles. Patients assigned to the
pembrolizumab monotherapy arm will receive treatment until a criterion for
discontinuation is met or a maximum of 24 months of treatment. Patients assigned to
combination therapy will receive both treatments until a criterion for discontinuation is
met or the patient has received a maximum of 24 months of treatment, after which they may
remain on danvatirsen monotherapy.
Patients in both treatment arms will have radiologic tumor assessments every 6 weeks (±1
week), regardless of treatment delays, until objective disease progression, initiation of
new anticancer treatment, death, withdrawal of consent, or end of study, whichever occurs
first.
All patients who discontinue study treatment for any reason will have a safety follow-up
visit 30 days (+7 days) after the last dose of study treatment and a follow-up for AEs 90
days (+7 days) after the last dose of pembrolizumab. Patients will be followed for
survival at 12 week (±7 days) intervals until death or withdrawal of consent, whichever
occurs first. Survival follow-up will continue until at least 15 months after the last
patient is randomized in the study.
Eligibility
- Must have given written informed consent (signed and dated).
- Aged =18 years at the time of informed consent.
- Recurrent/metastatic histologically or cytologically proven squamous cell carcinoma of the head and neck that is considered incurable by local therapy. Eligible primary tumor locations are oropharynx, oral cavity, hypopharynx, and larynx.
- Presence of measurable tumor per RECIST v1.1 criteria.
- Detectable PD-L1 expression in tumor, defined as CPS =1 determined by a FDA or national regulatory agency of the country in which the patient resides.-approved test.
- Baseline fresh tumor biopsy or archival specimen.
- ECOG performance status of 0 or 1.
- Adequate organ function within 10 days of study treatment,
- Oxygen saturation on room air =92% by pulse oximetry.
- Females must be non-pregnant and non-lactating and either be postmenopausal or agree to adequate birth control.
- Males must be surgically sterile or agree to adequate birth control.
- Has an estimated life expectancy of at least 3 months.
- Has recovered from all complications or surgery and all toxicities of prior therapy
Treatment Sites in Georgia
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