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)
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.
• 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