Combination Therapy With NC-6004 and Pembrolizumab in Head and Neck Cancer Subjects Who Have Failed Platinum Regimen

Inclusion Criteria:

• Be willing and able to provide written informed consent for the trial.
• Males or females aged ≥18 years at screening.
• Have an Eastern Cooperative Oncology Group (ECOG) Performance Status of 0 or 1.
• Have histologically- or cytologically-confirmed HNSCC.
• Have recurrent disease not amenable to curative treatment with local or systemictherapy, or metastatic (disseminated) HNSCC of the oral cavity, oropharynx,hypopharynx, or larynx that is considered incurable by local therapies.
• Having prior platinum failure.

Exclusion Criteria:

• Subjects with carcinoma of the nasopharynx, squamous cell carcinoma of unknown primaryorigination, squamous cell carcinoma that originates from the skin and salivary glandor paranasal sinus, nonsquamous histologies.
• Have disease that is suitable for locoregional treatment administered with curativeintent or refuses curative intent.
• Have no more than 15% body weight loss due to the underlying condition in the last 3months from signing of informed consent in Part 1 of the study and from randomizationin to Part 2.
• Are currently participating in or have participated in a study of an investigationalagent or are using an investigational device within 4 weeks prior to the first dose oftrial treatment.
• Were previously treated with 3 or more lines of systemic therapies administered forrecurrent and/or metastatic disease.