Title: A Phase 2 Study in First Line Metastatic or Unresectable, Recurrent Head and Neck Squamous Cell Carcinoma to Evaluate Intratumoral MK-1454 in Combination with IV Pembrolizumab vs IV Pembrolizumab Monotherapy
Description: The purpose of this study is to test the safety of the study drug, MK-1454, given as an intratumoral (IT) injection (a shot into your tumor or lesion) together with pembrolizumab compared to pembrolizumab alone, see if the study drug given as an IT injection together with pembrolizumab controls head and neck squamous cell carcinoma (HNSCC) better and helps patients live longer compared to pembrolizumab alone and see how well patients tolerate the study drug as an IT injection together with pembrolizumab compared to pembrolizumab alone.
MK-1454 that has not been approved for sale. Pembrolizumab (MK-3475), also known as KEYTRUDA®, has been approved by certain health authorities for the treatment of various cancers. However, it may not be approved for your exact type of cancer in your country.
• Male or Female, 18 years or greater at the time of signing consent.
• Has histologically or cytologically confirmed diagnosis of metastatic or unresectable, recurrent HNSCC that is considered incurable by local therapies.
• Has not had prior systemic therapy administered in the recurrent or metastatic setting. Systemic therapy which was completed more than 6 months prior to signing consent, if
given as part of multimodal treatment for locally advanced disease, is allowed.
• The eligible primary tumor must be located in oropharynx, oral cavity, hypopharynx, or larynx. Participants may not have a primary tumor site of nasopharynx (any histology).
• Has at least 1 measurable lesion which is amenable to injection. IT injection for cutaneous lesions may be performed via visual inspection. IT injection for subcutaneous lesions may be performed via ultrasound guidance or via palpation.
• Patients with progressive disease within 6 months of completion of curatively intended treatment for locoregionally advanced HNSCC will be excluded.
• Patients with disease that is suitable for local therapy administered with curative intent will be excluded.