Locally Advanced Head and Neck Squamous Cell Carcinoma Treatment Study
Study for pembrolizumab given concomitantly with chemoradiation and as maintenance therapy versus chemoradiation alone in subjects with locally advanced head and neck squamous cell carcinoma and to collect additional data on treatment safety.
In order to participate you must meet the following criteria:
Have a pathologically proven new diagnosis of squamous cell carcinoma of: a. Oropharyngeal p16 positive T4 (N0-N3), M0 or N3 (T1-T4), M0 OR b. Oropharyngeal p16 negative any T3-4 (N0-N3), M0 or any N2a-3 (T1-T4), M0 OR Larynx/hypopharynx/oral cavity (independent of p16) any T3-4 (N0-N3), M0 ; or any N2a-3 (T1-T4), M0.
Note: Subjects with oral cavity tumors need to have unresectable disease.
Have results from (local) testing of HPV status for oropharyngeal cancer defined as p16 IHC testing using CINtec® p16 Histology assay and a 70% cutoff point. If HPV status was previously tested using this method, no additional testing is required.
Note: Tumor p16 expression must be evaluated by assessment of IHC analysis with CINtec® p16 Histology assay (Ventana Medical Systems Inc., Tucson AZ) using ‘Benchmark Ultra’ autostainer (Ventana, Tucson, AZ) and standard protocol. Positive p16 expression is defined as strong and diffuse nuclear and cytoplasmic staining in 70% or more of the tumor cells.
Note: HPV stratification in this trial will be performed using local testing of HPV status in subjects with oropharynx cancer using the specified method.
Note: If local p16 testing results are not available, or cannot be assessed locally by the specified method, a tumor tissue sample may be submitted for p16 testing at the designated central laboratory.
Note: Oral cavity, hypopharynx, and larynx cancer are not required to undergo HPV testing by p16 IHC as by convention these tumor locations are assumed to be HPV-negative.
Have provided adequate tissue in terms of quality and quantity for PD-L1 biomarker analysis from a core or excisional biopsy (fine needle aspirate [FNA] is not adequate). Repeat samples may be required if adequate tissue is not provided.
Note: Central pathological review for p16 or PD-L1 will not be performed before inclusion. Formalin-fixed paraffin embedded (FFPE) tumor tissue sample blocks are preferred. If submitting unstained cut slides, freshly cut slides should be submitted to the testing laboratory within 14 days from the date slides are cut.
- Have evaluable tumor burden (measurable and/or non-measurable tumor lesions) assessed by CT scan or MRI, based on RECIST version 1.1.
You will be excluded from the study if any of the following criteria apply to you:
- Have current participation or treatment with an investigational agent or use of an investigational device within 4 weeks of the first dose of trial treatment.
- Have received prior therapy with an anti-PD-1, anti-PD-L1, anti-PD-L2 agent or with an agent directed to another co-inhibitory T-cell receptor (e.g., CTLA-4, OX-40, CD137 or other immune checkpoint inhibitors) or has previously participated in Merck MK-3475 clinical trials.
- Have received a live vaccine within 30 days prior to the first dose of study treatment.
- Have cancer outside of the oropharynx, larynx, and hypopharynx or oral cavity, such as nasopharyngeal, sinus, other para-nasal, or other unknown primary HNC.
This is a partial list of inclusion and exclusion criteria.