A Phase 3 Multicenter, Randomized, Open-label Study of ASP-1929 Photoimmunotherapy in Combination With Pembrolizumab Versus Standard of Care in the First-line Treatment of Patients With Locoregional Recurrence of Squamous Cell Carcinoma of the Head and Neck (HNSCC) With No Distant Metastases
Locoregional Recurrence of Squamous Cell Carcinoma of the Head and Neck (HNSCC)
Investigational medicinal product(s)
5-FU medac 50 mg/mlInjektionslösungPaclitaxel Ribosepharm 6 mg/ml Konzentrat zur Herstellung einer InfusionslösungCarboplatin Hikma 10 mg/ml Konzentrat zur Herstellung einer InfusionslösungCisplatinum Accord1 mg/mlkoncentrat do sporządzania roztworu do infuzji.ASP-1929KEYTRUDA 25 mg/mL concentrate for solution for infusion.Docetaxel Hikma 80 mg/4 ml Konzentrat zur Herstellung einer Infusionslösung
Eligibility
Age group
18-64 years, 65+ years
Sex
Female, Male
Primary endpoint
Overall Survival (OS): OS is defined as the time from randomisation to death from any cause.
Endpoint detail
Key Secondary: • Complete Response Rate: CRR is defined as the proportion of patients with best overall response of confirmed CR per modified RECIST 1.1 as assessed by central reviewer. • Objective Response Rate: ORR is defined as the proportion of patients with best overall response of confirmed CR or confirmed PR per modified RECIST 1.1 as assessed by central reviewer.
Official registry record
This page summarises publicly available CTIS data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.
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