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Combining danvatirsen and pembrolizumab for treating advanced head and neck cancer

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)

Phase 2 Interventional Flamingo Therapeutics NV · NCT05814666

This study is testing if combining two treatments, danvatirsen and pembrolizumab, can help people with advanced head and neck cancer do better than just using pembrolizumab alone.

Quick facts

PhasePhase 2
Study typeInterventional
Enrollment81 (estimated)
Ages18 Years and up
SexAll
SponsorFlamingo Therapeutics NV Industry-sponsored
Drugs / interventionspembrolizumab, Radiation, prednisone
Locations32 sites (Tucson, Arizona and 31 other locations)
Trial IDNCT05814666 on ClinicalTrials.gov

What this trial studies

This Phase II clinical trial evaluates the effectiveness and safety of danvatirsen in combination with pembrolizumab compared to pembrolizumab alone for patients with recurrent or metastatic head and neck squamous cell carcinoma (HNSCC). Patients will be randomly assigned to receive either the combination treatment or pembrolizumab monotherapy, with treatment cycles lasting 21 days. The study will assess clinical and biological activity through tumor assessments every six weeks until disease progression or other criteria for discontinuation are met. Eligible participants must provide a tumor sample and meet specific health criteria.

Who should consider this trial

Good fit: Ideal candidates are adults aged 18 and older with recurrent or metastatic HNSCC that is not amenable to local therapy and has detectable PD-L1 expression.

Not a fit: Patients with non-squamous cell carcinoma or those who do not express PD-L1 may not benefit from this study.

Why it matters

Potential benefit: If successful, this treatment combination could provide a new first-line therapy option for patients with advanced HNSCC.

How similar studies have performed: Previous studies have shown promise in using immunotherapy combinations for HNSCC, suggesting potential for success in this approach.

Eligibility criteria

Show full inclusion / exclusion criteria 
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.

Where this trial is running

Tucson, Arizona and 31 other locations

Study contacts

How to participate

  1. Review the eligibility criteria above with your treating physician.
  2. Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
  3. Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
View on ClinicalTrials.gov → Find more trials like this →
Conditions HNSCC
Last reviewed 2026-06-13 by the Find a Trial editorial team. Information on this page is for educational purposes and is not medical advice. Always consult qualified healthcare professionals about clinical trial participation.