A Study of ASP-1929 Photoimmunotherapy in Combination With Pembrolizumab in First-line Treatment of Locoregional Recurrent Squamous Cell Carcinoma of the Head and Neck With No Distant Metastases
Trial Parameters
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Brief Summary
The goal of this clinical trial is to learn if ASP-1929 photoimmunotherapy (PIT) in combination with pembrolizumab works to treat recurrent squamous cell cancer of the head and neck (HNSCC) with no distant metastases. It will also learn about the safety of ASP-1929 PIT in combination with pembrolizumab. Researchers will compare ASP-1929 PIT in combination with pembrolizumab to pembrolizumab alone or pembrolizumab plus chemotherapy (carboplatin or cisplatin, plus 5-fluorouracil or paclitaxel or docetaxel) according to physician's choice (control arm). The overall primary study hypothesis being tested is whether ASP-1929 PIT plus pembrolizumab combination treatment improves the overall survival (OS) of the population defined by the inclusion/exclusion criteria over the control arm.
Eligibility Criteria
Inclusion Criteria: * Histological or cytological evidence of squamous cell carcinoma of a head and neck primary site (per American Joint Committee on Cancer \[AJCC\], other than nasopharynx or cuSCC). * Appropriate for SOC first-line treatment of their recurrent head and neck cancer with pembrolizumab ± chemotherapy. * No known history of any distant metastatic disease (M1 by AJCC eighth edition). * Tumors with at least one PIT-accessible and RECIST 1.1 measurable lesion as assessed by investigator. * Anti-PD-1 and anti-PD-L1-treatment naïve. * Combined positive score (CPS) ≥ 1 as determined locally by an FDA-approved test * Have results from testing of human papillomavirus (HPV) status for oropharyngeal cancer * Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1 at the time of screening * Adequate hematologic, renal, and hepatic organ function * Women of childbearing potential (WOCBP) must have a negative pregnancy test at screening and must be willing to use a hi