Clinical trialNCT06699212RecruitingPhase 3Interventional

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

SponsorRakuten Medical, Inc.Enrollment412Recurrent Head and Neck Squamous Cell Carcinoma

View the registry record on ClinicalTrials.gov

Summary

The lay summary the sponsor registered on ClinicalTrials.gov.

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.

clinicaltrials.gov ↗

Investigators

The overall officials registered on this study. Names that resolve to a findmyKOL profile link to it; the rest are shown as registered.

Ethan Chen, MD
Rakuten Medical, Inc.
Study Director
clinicaltrials.gov ↗
Rebecca Cheng, MD
Rakuten Medical, Inc.
Study Director
clinicaltrials.gov ↗

A profile link is shown only when the registered name resolves to a person record with a confident, namesake-checked match; ambiguous names stay unlinked.

Sites

22 registered facilities, with the per-site recruitment status where the registry publishes one. ClinicalTrials.gov does not publish per-site enrollment counts.

Japan

Aichi Cancer Center
Aichi, Japan
Nobuhiro Hanai, MD
Recruiting
Hiroshima University Hospital
Hiroshima, Japan
Tsutomu Ueda, MD
Recruiting
Kyoto Prefectural University of Medicine
Kyoto, Japan
Shigeru Hirano, MD
Recruiting
Tokyo Medical University Hospital
Tokyo, Japan
Kiyoaki Tsukahara, MD
Recruiting
Tottori University Hospital
Yonago, Japan
Kazunori Fujiwara, MD
Recruiting

Taiwan

Kaohsiung Medical University Chung-Ho Memorial Hospital
Kaohsiung City, Taiwan
Hui-Ching Wang, MD
Recruiting
China Medical University
Taichung, Taiwan
Ming-Yu Lien, MD
Recruiting
Taichung Veterans General Hospital
Taichung, Taiwan
Chen-Chi Wang, MD
Recruiting
Chi Mei Hospital
Tainan, Taiwan
Cheng-Yao Lin, MD
Recruiting
Mackay Memorial Hospital
Taipei, Taiwan
Yi-Shing Leu, MD
Recruiting
National Taiwan University Hospital
Taipei, Taiwan
Pei-Jen Lou, MD
Recruiting
Taipei Municipal Wanfang Hospital
Taipei, Taiwan
Kuan-Chou Lin, MD
Recruiting
Taipei Veterans General Hospital
Taipei, Taiwan
Cheng-Hsien Wu, MD
Recruiting
Linkou Chang Gung Memorial Hospital
Taoyuan City, Taiwan
Kai-Ping Chang, MD
Recruiting

United States

City of Hope
Duarte, California, United States
Krupal Patel, MD
Recruiting
University of Miami
Miami, Florida, United States
Francisco Jose Civantos, MD
Recruiting
Tampa General Hospital
Tampa, Florida, United States
Matthew Mifsud, MD
Recruiting
University of Kentucky Medical Center
Lexington, Kentucky, United States
Withdrawn
Thomas Jefferson University, Sidney Kimmel Cancer Center
Philadelphia, Pennsylvania, United States
David Cognetti, MD
Recruiting
Rhode Island Hospital
Providence, Rhode Island, United States
Ariel Birnbaum, MD
Recruiting
Avera Cancer Institute
Sioux Falls, South Dakota, United States
William Spanos, MD
Recruiting
University of Texas, Md Anderson Cancer Center
Houston, Texas, United States
Ann Gillenwater, MD
Recruiting

Site investigator names are published by ClinicalTrials.gov only while a study recruits, so completed studies list sites without them.

Drugs studied

The drug and biological interventions registered on this study, normalized to their RxNorm ingredient where possible.

Fluorouracil →Carboplatin →Cisplatin →Docetaxel →Paclitaxel →Pembrolizumab →

Linked drugs open the directory filtered to KOLs working with them.clinicaltrials.gov ↗

Registration & key dates

Registry attributes as recorded on the ClinicalTrials.gov study record.

Start: 24 Dec 2024
Primary completion: 30 Sept 2028
Completion: 30 Sept 2028
Last update posted: 15 Oct 2025
Registered enrollment: 412
Registry id: NCT06699212

clinicaltrials.gov ↗

Source: ClinicalTrials.gov, via the CTTI AACT database, data as of 24 Aug 2026. Registry facts are shown as registered by the study sponsor; findmyKOL does not interpret them.