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Terminated Phase 2 Interventional Results available

Activity and Safety of Danvatirsen and Pembrolizumab in HNSCC

ClinicalTrials.gov ID: NCT05814666

Public ClinicalTrials.gov record NCT05814666. Field values are reproduced from the official study page; the official ClinicalTrials.gov record remains the source of truth for eligibility, enrollment, and contact information.

ClinicalTrials.gov public records Last synced Oct 19, 2026, 12:30 PM EDT

Data is sourced from official ClinicalTrials.gov public API records. Always review the official ClinicalTrials.gov record for the latest information.

Official title

An Open-Label, Phase II, Randomized, Controlled Study of Danvatirsen Plus Pembrolizumab Compared to Pembrolizumab Alone in Recurrent or Metastatic Head and Neck Squamous Cell Carcinoma (HNSCC)

Brief summary

Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.

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.

Study identification

NCT ID
NCT05814666
Recruitment status
Terminated
Study type
Interventional
Phase
Phase 2
Lead sponsor
Flamingo Therapeutics NV
Industry
Enrollment
69 participants

Conditions and interventions

Conditions

Interventions

Drug

Eligibility (public fields only)

Age range
18 Years and older
Sex
All
Healthy volunteers
Healthy volunteers not accepted

This page does not interpret eligibility. Detailed inclusion and exclusion criteria are on the official ClinicalTrials.gov record.

Study timeline

Start date
May 30, 2023 (Actual)
Primary completion
Aug 14, 2025 (Actual)
Completion
Aug 14, 2025 (Actual)
Last update posted
Jan 30, 2026

2023 – 2025

United States locations

U.S. sites
21
U.S. states
15
U.S. cities
20
Facility City State ZIP Site status
The University of Arizona Cancer Center Tucson Arizona 85719 —
University of California Irvine (UCI) Irvine California 92617 —
TMPN Hunt Cancer Care Torrance California 90505 —
University of California Los Angeles Westwood, Los Angeles California 90024 —
University of Colorado Hospital (UCH) Anschutz Cancer Pavilion Aurora Colorado 80045 —
Miami Cancer Institute Miami Florida 33176 —
Emory University Hospital Midtown Atlanta Georgia 30308 —
University of Illinois Cancer Center Chicago Illinois 60612 —
AMR Kansas City Oncology Merriam Kansas 66204 —
University of Kansas Medical Center Westwood Kansas 66205 —
Mary Bird Perkins Cancer Center Baton Rouge Louisiana 70809 —
University of Maryland Baltimore, Greenebaum Comprehensive Cancer Center Baltimore Maryland 21201 —
Comprehensive Cancer Centers of Nevada Las Vegas Nevada 89169 —
Morristown Medical Center Morristown New Jersey 07960 —
Mount Sinai New York New York 10029 —
Stony Brook Cancer Center Stony Brook New York 11794 —
The Christ Hospital Cancer Center Cincinnati Ohio 45219 —
University of Cincinnati Medical Center Cincinnati Ohio 45229 —
University Hospitals Cleveland Cleveland Ohio 44106 —
Prisma Health Cancer Institute Greenville South Carolina 29605 —
UT Southwestern Medical Center/Simmons Comprehensive Cancer Center Dallas Texas 75390 —

Site contact phone numbers, emails, and investigator names are intentionally not displayed here. Open the official ClinicalTrials.gov record for site contact information.

Non-U.S. locations

This page focuses on the U.S. directory. The official record also lists 11 non-U.S. sites.

About this trial record page

What this page shows
Public field values for ClinicalTrials.gov record NCT05814666, including study identification, conditions, interventions, eligibility (age, sex, healthy volunteer), timeline, and U.S. site list.
What this page does not do
No medical advice, eligibility judgments, treatment recommendations, study quality scoring, or AI-generated medical summaries. No site contact phone numbers, emails, or investigator names.
Where the data comes from
Sourced from the official ClinicalTrials.gov public API. The official record is the source of truth.
Last refresh
Last update posted Jan 30, 2026 · Synced Oct 19, 2026

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Open the official record

The complete public registry record, listed eligibility criteria, and available contact information for NCT05814666 live on ClinicalTrials.gov.

View official ClinicalTrials.gov record →