Activity and Safety of Danvatirsen and Pembrolizumab in HNSCC

Stopped early · Phase 2

Conditions studied: HNSCC

In brief

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.

Key facts

Study ID

NCT05814666

Run by

Flamingo Therapeutics NV

People needed

69

Starts

2023-05-30

Expected to finish

2025-08-14

Last updated by the study team

2026-01-30

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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

You may not qualify if…

• Prior therapy for metastatic HNSCC.
• Has disease suitable for local therapy with curative intent.
• Primary tumor of the nasopharynx.
• Has received prior therapy with an anti-programmed death 1 (PD-1), anti PD L1, or anti-programmed death-ligand-2 (PD-L2).
• Radiation therapy (or other non-systemic therapy) within 2 weeks of Day 1 of study treatment.
• Known autoimmune disease that has required systemic treatment
• Known immunodeficiency or receiving systemic steroid therapy that would be the equivalent of >10 mg prednisone daily
• Prior allogeneic tissue/solid organ transplant.
• Has significant cardiovascular disease
• Has received a live vaccine within 30 days
• Active infection requiring systemic antiviral or antimicrobial therapy
• History of (non-infectious) pneumonitis that required steroids or current pneumonitis.
• History of other malignancies
• Active HIV infection except patients who are currently stable on antiretroviral therapy for at least 4 weeks
• Active hepatitis B virus (HBV) or hepatitis C virus (HCV) infection.
• Treated or untreated parenchymal brain metastases or leptomeningeal disease.
• 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.
• Hypersensitivity to any component of danvatirsen or pembrolizumab.

Where it is running

• 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

Full record on ClinicalTrials.gov

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