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Study identifier: NCT06699212 Synced from ClinicalTrials.gov · July 29, 2026
● Recruiting

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

Condition: Recurrent Head and Neck Squamous Cell Carcinoma  ·  Sponsor: Rakuten Medical, Inc.

PhasePhase 3
Planned participants412
Who can joinAll sexes, 18 Years to no upper limit
Healthy volunteersNo

About this study

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.

This description comes directly from the study's public registry record.

Talk to the study team

ASP-1929-381 Study Team  ·  858-207-3113  ·  clinicaltrialinfo@rakuten-med.com

Always discuss trial participation with your own doctor first.

Locations (22)

City of HopeDuarte, California, United StatesRecruiting
University of MiamiMiami, Florida, United StatesRecruiting
Tampa General HospitalTampa, Florida, United StatesRecruiting
University of Kentucky Medical CenterLexington, Kentucky, United StatesWithdrawn
Thomas Jefferson University, Sidney Kimmel Cancer CenterPhiladelphia, Pennsylvania, United StatesRecruiting
Rhode Island HospitalProvidence, Rhode Island, United StatesRecruiting
Avera Cancer InstituteSioux Falls, South Dakota, United StatesRecruiting
University of Texas, MD Anderson Cancer CenterHouston, Texas, United StatesRecruiting
Aichi Cancer CenterAichi, JapanRecruiting
Hiroshima University HospitalHiroshima, JapanRecruiting
Kyoto Prefectural University of MedicineKyoto, JapanRecruiting
Tokyo Medical University HospitalTokyo, JapanRecruiting

+ 10 more locations — full list on the registry record.

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Source record: clinicaltrials.gov/study/NCT06699212