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

Status

Not yet recruiting

Phases

Phase 3

Study type

Interventional

Source

EU CTIS

Registry ID

CTIS2025-523017-28-00

Enrollment

Registered

2026-04-03

Start date

Unknown

Completion date

Unknown

Last updated

2026-04-03

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Locoregional Recurrence of Squamous Cell Carcinoma of the Head and Neck (HNSCC)

Brief summary

Overall Survival (OS): OS is defined as the time from randomisation to death from any cause.

Detailed description

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.

Interventions

DRUGKEYTRUDA 25 mg/mL concentrate for solution for infusion.

DRUGCisplatinum Accord

DRUG1 mg/ml

DRUGkoncentrat do sporządzania roztworu do infuzji.

DRUGDocetaxel Hikma 80 mg/4 ml Konzentrat zur Herstellung einer Infusionslösung

DRUG5-FU medac 50 mg/ml

DRUGInjektionslösung

DRUGCarboplatin Hikma 10 mg/ml Konzentrat zur Herstellung einer Infusionslösung

DRUGPaclitaxel Ribosepharm 6 mg/ml Konzentrat zur Herstellung einer Infusionslösung

DRUGASP-1929

Eligibility

Sex/Gender

All

Age

18 Years to No maximum

Design outcomes

Primary

Measure	Time frame
Overall Survival (OS): OS is defined as the time from randomisation to death from any cause.	—

Secondary

Measure	Time frame
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.	—

Outcome results

None listed

Source: EU CTIS · Data processed: Apr 4, 2026