Activity and Safety of Danvatirsen and Pembrolizumab in HNSCC
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.
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
- Enrollment
- 69 participants
Conditions and interventions
Conditions
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 29, 2023
- Primary completion
- Aug 13, 2025
- Completion
- Aug 13, 2025
- Last update posted
- Jan 29, 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 29, 2026 · Synced Sep 3, 2026
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Open the official record
The complete protocol, eligibility criteria, and contact information for NCT05814666 live on ClinicalTrials.gov.