Activity and Safety of Danvatirsen and Pembrolizumab in HNSCC
NCT ID: NCT05814666
Last Updated: 2026-01-30
Study Results
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View full resultsBasic Information
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TERMINATED
PHASE2
69 participants
INTERVENTIONAL
2023-05-30
2025-08-14
Brief Summary
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Detailed Description
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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.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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Danvatirsen plus pembrolizumab
Danvatirsen dosing:
Week 1: Danvatirsen intravenously (IV) on Days 1, 3, and 5
Week 2 and subsequent weeks: Danvatirsen IV weekly
Pembrolizumab dosing:
Pembrolizumab every 3 weeks after the Danvatirsen dose.
Danvatirsen
Danvatirsen is a STAT3 targeting drug.
Pembrolizumab
Pembrolizumab is a monoclonal antibody that binds to the PD-1 receptor and blocks its interaction with PD-L1 and PD-L2
Pembrolizumab
Pembrolizumab IV every 3 weeks
Pembrolizumab
Pembrolizumab is a monoclonal antibody that binds to the PD-1 receptor and blocks its interaction with PD-L1 and PD-L2
Interventions
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Danvatirsen
Danvatirsen is a STAT3 targeting drug.
Pembrolizumab
Pembrolizumab is a monoclonal antibody that binds to the PD-1 receptor and blocks its interaction with PD-L1 and PD-L2
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
2. Aged ≥18 years at the time of informed consent.
3. 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.
4. Presence of measurable tumor per RECIST v1.1 criteria.
5. 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.
6. Baseline fresh tumor biopsy or archival specimen.
7. ECOG performance status of 0 or 1.
8. Adequate organ function within 10 days of study treatment,
9. Oxygen saturation on room air ≥92% by pulse oximetry.
10. Females must be non-pregnant and non-lactating and either be postmenopausal or agree to adequate birth control.
11. Males must be surgically sterile or agree to adequate birth control.
12. Has an estimated life expectancy of at least 3 months.
13. Has recovered from all complications or surgery and all toxicities of prior therapy
Exclusion Criteria
2. Has disease suitable for local therapy with curative intent.
3. Primary tumor of the nasopharynx.
4. Has received prior therapy with an anti-programmed death 1 (PD-1), anti PD L1, or anti-programmed death-ligand-2 (PD-L2).
5. Radiation therapy (or other non-systemic therapy) within 2 weeks of Day 1 of study treatment.
6. Known autoimmune disease that has required systemic treatment
7. Known immunodeficiency or receiving systemic steroid therapy that would be the equivalent of \>10 mg prednisone daily
8. Prior allogeneic tissue/solid organ transplant.
9. Has significant cardiovascular disease
10. Has received a live vaccine within 30 days
11. Active infection requiring systemic antiviral or antimicrobial therapy
12. History of (non-infectious) pneumonitis that required steroids or current pneumonitis.
13. History of other malignancies
14. Active HIV infection except patients who are currently stable on antiretroviral therapy for at least 4 weeks
15. Active hepatitis B virus (HBV) or hepatitis C virus (HCV) infection.
16. Treated or untreated parenchymal brain metastases or leptomeningeal disease.
17. Treatment with another investigational drug, biological agent, or device within 1 month of screening, or 5 half-lives of investigational agent (if known), whichever is longer.
18. Hypersensitivity to any component of danvatirsen or pembrolizumab.
18 Years
ALL
No
Sponsors
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Flamingo Therapeutics NV
INDUSTRY
Responsible Party
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Principal Investigators
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Nabil Saba, MD
Role: STUDY_CHAIR
Emory University
Locations
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The University of Arizona Cancer Center
Tucson, Arizona, United States
University of California Irvine (UCI)
Irvine, California, United States
TMPN Hunt Cancer Care
Torrance, California, United States
University of California Los Angeles
Westwood, Los Angeles, California, United States
University of Colorado Hospital (UCH) Anschutz Cancer Pavilion
Aurora, Colorado, United States
Miami Cancer Institute
Miami, Florida, United States
Emory University Hospital Midtown
Atlanta, Georgia, United States
University of Illinois Cancer Center
Chicago, Illinois, United States
AMR Kansas City Oncology
Merriam, Kansas, United States
University of Kansas Medical Center
Westwood, Kansas, United States
Mary Bird Perkins Cancer Center
Baton Rouge, Louisiana, United States
University of Maryland Baltimore, Greenebaum Comprehensive Cancer Center
Baltimore, Maryland, United States
Comprehensive Cancer Centers of Nevada
Las Vegas, Nevada, United States
Morristown Medical Center
Morristown, New Jersey, United States
Mount Sinai
New York, New York, United States
Stony Brook Cancer Center
Stony Brook, New York, United States
The Christ Hospital Cancer Center
Cincinnati, Ohio, United States
University of Cincinnati Medical Center
Cincinnati, Ohio, United States
University Hospitals Cleveland
Cleveland, Ohio, United States
Prisma Health Cancer Institute
Greenville, South Carolina, United States
UT Southwestern Medical Center/Simmons Comprehensive Cancer Center
Dallas, Texas, United States
Dong-A University Hospital
Busan, , South Korea
Kosin University College of Medicine - Kosin University Gospel Hospital (KUGH)
Busan, , South Korea
Gyeongsang National University Hospital
Jinju, , South Korea
Korea University Medical Center (KUMC)
Seoul, , South Korea
The Catholic University of Korea - Eunpyeong St. Mary's Hospital
Seoul, , South Korea
Saint James's University Hospital (SJUH) - St James's Institute of Oncology
Leeds, , United Kingdom
The Clatterbridge Cancer Centre NHS Foundation Trust
Liverpool, , United Kingdom
Barts Health MHS Trust (Barts and The London NHS Trust) - St Bartholomew's (Barts) Hospital
London, , United Kingdom
The Royal Marsden NHS Foundation Trust
London, , United Kingdom
East and North Hertfordshire NHS Trust, Lister Hospital
Northwood, , United Kingdom
The Royal Marsden NHS Foundation Trust
Sutton, , United Kingdom
Countries
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Provided Documents
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Document Type: Study Protocol
Document Type: Statistical Analysis Plan
Other Identifiers
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FLM-6774-201
Identifier Type: -
Identifier Source: org_study_id
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