Activity and Safety of Danvatirsen and Pembrolizumab in HNSCC

Active:	Yes
Cancer Type:	Head and Neck Cancer	NCT ID:	NCT05814666
Trial Phases:	Phase II	Protocol IDs:	FLM-6774-201 (primary) NCI-2023-08785
Eligibility:	18 Years and older, Male and Female	Study Type:	Treatment
Study Sponsor:	Flamingo Therapeutics NV
NCI Full Details:	http://clinicaltrials.gov/show/NCT05814666

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.

Treatment Sites in Georgia

Winship Cancer Institute of Emory University
1365 Clifton Road NE
Building C
Atlanta, GA 30322
winshipcancer.emory.edu

**Clinical trials are research studies that involve people. These studies test new ways to prevent, detect, diagnose, or treat diseases. People who take part in cancer clinical trials have an opportunity to contribute to scientists’ knowledge about cancer and to help in the development of improved cancer treatments. They also receive state-of-the-art care from cancer experts... Click here to learn more about clinical trials.