Clinical Trial TitleThe PATHWay study: A randomized, double-blind phase II study of pembrolizumab versus placebo in patients with head and neck cancers at high risk for recurrence or low-volume residual disease.
Clinical Trial Protocol Description:
Study for pembrolizumab given versus placebo for subjects with head and neck cancers and to collect additional data on treatment safety.
Clinical Trial Eligibility Criteria:
In order to participate you must meet the following criteria:
- Have histologically confirmed head and neck cancer (squamous cell histology as well as HPV+ and/or EBV+ head and neck tumors), stages IVA, IVB, and select cases of stage III (see additional criteria below).
- Have completed curative intent therapy, without additional standard of care curative intent therapy feasible (see below for additional details).
- Have availability of tumor tissue (≥10 slides) for PD-L1, gene expression profiling (GEP), and additional testing.
- Have a performance status of 0 or 1 on the ECOG Performance Scale. An ECOG performance status of 2 is acceptable if the patient was ECOG 0/1 prior to curative intent therapy and is in the midst of recovery from curative intent therapy
You will be excluded from the study if any of the following criteria apply to you:
- Have measurable disease that is amenable to curative intent therapy, or amenable to standard of care systemic/palliative therapy (e.g. platinum containing chemotherapy, cetuximab, pembrolizumab or other approved options).
- Have a diagnosis of immunodeficiency or is receiving systemic steroid therapy (>10mg of prednisone equivalent) or any other form of immunosuppressive therapy within 7 days prior to the first dose of trial treatment.
- Are currently participating and receiving study therapy or have participated in a study of an investigational agent and received study therapy or used an investigational device within 2 weeks of the first dose of treatment.
- Have a known history of active TB (Bacillus Tuberculosis).
This is a partial list of inclusion and exclusion criteria.