Protocol Title: An Open-Label, Phase II, Randomized, Controlled Study of Danvatirsen Plus Pembrolizumab Compared to Pembrolizumab Alone in Recurrent or Metastatic Head and Neck Sqaumous Cell Carcinoma (HNSCC)

Sponsor: Flamingo

Protocol Number: FLM-6774-201

Key Criteria

  • Patient has recurrent/metastatic histologically/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
    • larynx
  • Patient’s tumor is measurable per RECIST 1.1 criteria
  • PD-L1 expression in tumor is detectable (defined as CPS > 20 determined by a FDA-approved test)Baseline fresh tumor biopsy or archival specimen is available. Patient’s oxygen saturation on room air ≥92% by pulse oximetry
  • Patient has life expectancy of at least 3 months
  • Excluded if
    • Patient has received prior therapy for metastatic HNSCC.
      • Systemic therapy for locoregionally recurrent HNSCC completed more than 6 months before signing consent is allowed If it was given as multimodal treatment for locally advanced disease
    • Patient has disease that is suitable for local therapy with curative intent
    • Patient has a primary tumor of the nasopharynx
    • Patient has been treated with an anti-PD-1, anti-PD-L1, or anti-PD-L2.
    • Patient has a known autoimmune disease requiring systemic treatment in the past year
    • Patient has known immunodeficiency or is receiving systemic steroid therapy ( > 10 mg prednisone QD) within a week before first dose of study treatment
    • Patient is an allogenic tissue/solid organ transplant recipient
    • Patient has history of non-infectious pneumonitis requiring steroids or currently has pneumonitis
    • Patient has history of other malignancies  (with some exceptions)Patient has received treatment for or is untreated for parenchymal brain metastases or leptomeningeal disease

Talking Points

  • Study objective: This study will compare the response rate, efficacy and safety of combination of danvatirsen with pembrolizumab versus pembrolizumab alone as first line treatment option in patients with metastatic or unresectable, recurrent HNSCC with tumors expressing PD-L1
    • Study duration: until disease progression, unacceptable toxicity or voluntary withdrawal
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