Clinical Trial TitleA phase III, randomized, open-label study to evaluate pembrolizumab as neoadjuvant therapy and in combination with standard of care as adjuvant therapy for stage III-IVA resectable locoregionally advanced head and neck squamous cell carcinoma (LA HNSCC).
Clinical Trial Protocol Description:
Study for subjects with stage III-IVA resectable locoregionally advanced head and neck cancer will benefit from pembrolizumab as neoadjuvant therapy and in combination with standard of care as adjuvant therapy 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 new diagnosis of resectable, non-metastatic, squamous cell carcinoma as assessed by the investigator based on baseline imaging and clinical assessment that is either:
- Stage III oropharyngeal p16 positive that is T4 (N0-N2), M0
- Stage III or IVA oropharyngeal p16 negative
- Stage III or IVA larynx/hypopharynx/oral cavity (independent of p16)
Note: Participants with newly diagnosed HNSCC who underwent partial surgical resection and have gross residual disease are eligible for the study if additional surgery and adjuvant treatment is required.
Note: Participants with multiple primary HNSCC tumors are eligible for the study if at least one of the tumors meets eligibility criteria based on staging after consultation with and approval by the sponsor.
- Are eligible for primary surgery based on investigator decision and per local practice.
- Have evaluable tumor burden (measurable and/or non-measurable tumor lesions) assessed by computed tomography (CT) scan or magnetic resonance imaging (MRI), based on RECIST 1.1 as assessed by the local site investigator/radiology.
- Have provided archival tumor tissue sample or newly obtained core or excisional biopsy of a tumor lesion not previously irradiated for PD-L1 biomarker analysis from a core or excisional biopsy (fine needle aspirate [FNA] is not adequate). Formalin-fixed, paraffin embedded tissue blocks are preferred to slides. Newly obtained biopsies are preferred to archived tissue.
You will be excluded from the study if any of the following criteria apply to you:
- Have stage T4B and/or N3 LA HNSCC and/or distant metastases.
- Have cancer outside of the oropharynx, larynx, and hypopharynx or oral cavity, such as nasopharyngeal, sinus, other para-nasal, or other unknown primary HNC.
- Are a woman of childbearing potential who has a positive urine pregnancy test within 72 hours prior to randomization or within 24 hours prior to the start of RT ± cisplatin. If the urine test is positive or cannot be confirmed as negative, a serum pregnancy test will be required. In such cases, the participant must be excluded from participation if the serum pregnancy result is positive.
- Have received prior therapy with an anti-PD-1, anti-PD-L1, or anti-PD-L2 agent or with an agent directed to another co-inhibitory T-cell receptor (eg, CTLA-4, OX-40, CD137).
This is a partial list of inclusion and exclusion criteria.