Clinical Trial

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

Study acronym: ECLIPSE
Recruiting Phase 3
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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.
Protocol Amendment History 6 amendments
This ClinicalTrials.gov record has been amended 6 times since 2024-11-18; most recent amendment 2025-10-13.
Status change: Not Yet Recruiting → Recruiting 2025-01-03
Trial Details
NCT Number NCT06699212
Lead Sponsor Rakuten Medical, Inc.
Conditions Recurrent Head and Neck Squamous Cell Carcinoma
Enrollment 412 participants
Start Date 2024-12-24
Primary Completion 2028-09 (estimated)
Study Completion 2028-09 (estimated)
Updated on ClinicalTrials.gov 2025-10-15