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Experimental combo for head and neck cancer shows promise, but trial halted early

NCT ID NCT05814666

Disease control Sponsor: Flamingo Therapeutics NV Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early This study
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 27, 2026 · Last updated Jun 27, 2026

Summary

This Phase 2 trial tested whether adding danvatirsen to the standard immunotherapy pembrolizumab helps people with recurrent or metastatic head and neck squamous cell carcinoma. About 69 adults with PD-L1 positive tumors were randomly assigned to receive the combination or pembrolizumab alone. The study was terminated early, so its findings are limited.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
danvatirsen and pembrolizumab
What this could lead to
If it works, this combination could offer a new treatment option for people with advanced head and neck cancer that has returned or spread.
What could go wrong
The trial was terminated early, so results are limited. It is a small Phase 2 study, and the combination may not prove more effective or safe than pembrolizumab alone.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Phase 2

Tests whether the treatment actually works, and watches for side effects, in a larger group.

Participants

69 people

The number who actually took part.

Started

May 2023

Finished

Aug 2025

Lead sponsor

A company

The lead sponsor is a pharmaceutical, biotech, or medical-device company.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

18 years and older

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

Inclusion Criteria: 1. Must have given written informed consent (signed and dated). 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: 1. Prior therapy for metastatic HNSCC. 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.

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Conditions

The condition(s) this trial relates to.

head and neck squamous cell carcinoma Squamous Cell Carcinoma of Head and Neck

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

HNSCC

Contacts and locations

Locations

  • AMR Kansas City Oncology

    Merriam, Kansas, 66204, United States

  • Barts Health MHS Trust (Barts and The London NHS Trust) - St Bartholomew's (Barts) Hospital

    London, EC1A 7BE, United Kingdom

  • Comprehensive Cancer Centers of Nevada

    Las Vegas, Nevada, 89169, United States

  • Dong-A University Hospital

    Busan, 49201, South Korea

  • East and North Hertfordshire NHS Trust, Lister Hospital

    Northwood, HA6 2RN, United Kingdom

  • Emory University Hospital Midtown

    Atlanta, Georgia, 30308, United States

  • Gyeongsang National University Hospital

    Jinju, 52727, South Korea

  • Korea University Medical Center (KUMC)

    Seoul, 02841, South Korea

  • Kosin University College of Medicine - Kosin University Gospel Hospital (KUGH)

    Busan, 602-702, South Korea

  • Mary Bird Perkins Cancer Center

    Baton Rouge, Louisiana, 70809, United States

  • Miami Cancer Institute

    Miami, Florida, 33176, United States

  • Morristown Medical Center

    Morristown, New Jersey, 07960, United States

  • Mount Sinai

    New York, New York, 10029, United States

  • Prisma Health Cancer Institute

    Greenville, South Carolina, 29605, United States

  • Saint James's University Hospital (SJUH) - St James's Institute of Oncology

    Leeds, United Kingdom

  • Stony Brook Cancer Center

    Stony Brook, New York, 11794, United States

  • TMPN Hunt Cancer Care

    Torrance, California, 90505, United States

  • The Catholic University of Korea - Eunpyeong St. Mary's Hospital

    Seoul, South Korea

  • The Christ Hospital Cancer Center

    Cincinnati, Ohio, 45219, United States

  • The Clatterbridge Cancer Centre NHS Foundation Trust

    Liverpool, United Kingdom

  • The Royal Marsden NHS Foundation Trust

    London, SW3 6JJ, United Kingdom

  • The Royal Marsden NHS Foundation Trust

    Sutton, SM2 5PT, United Kingdom

  • The University of Arizona Cancer Center

    Tucson, Arizona, 85719, United States

  • UT Southwestern Medical Center/Simmons Comprehensive Cancer Center

    Dallas, Texas, 75390, United States

  • University Hospitals Cleveland

    Cleveland, Ohio, 44106, United States

  • University of California Irvine (UCI)

    Irvine, California, 92617, United States

  • University of California Los Angeles

    Westwood, Los Angeles, California, 90024, United States

  • University of Cincinnati Medical Center

    Cincinnati, Ohio, 45229, United States

  • University of Colorado Hospital (UCH) Anschutz Cancer Pavilion

    Aurora, Colorado, 80045, United States

  • University of Illinois Cancer Center

    Chicago, Illinois, 60612, United States

  • University of Kansas Medical Center

    Westwood, Kansas, 66205, United States

  • University of Maryland Baltimore, Greenebaum Comprehensive Cancer Center

    Baltimore, Maryland, 21201, United States

More trials for these conditions

Other studies related to the condition(s) this trial covers.