Light-Activated drug combo takes on recurrent head and neck cancer in major trial

NCT ID NCT06699212

Recruiting now Disease control Sponsor: Rakuten Medical, Inc. Source: ClinicalTrials.gov ↗

First seen Jun 24, 2026 · Last updated Jun 27, 2026 · Updated 1 time

Summary

This phase 3 trial tests whether a new treatment called ASP-1929 photoimmunotherapy (a light-activated drug) combined with the immunotherapy pembrolizumab works better than standard care for people with recurrent head and neck cancer that hasn't spread to other parts of the body. About 412 participants will be randomly assigned to receive either the new combination or standard treatment (pembrolizumab alone or with chemotherapy). The main goal is to see if the new combination helps people live longer.

What this could mean

Our plain-language read of the trial. This is informational only — not medical advice or a prediction.

Active substance: ASP-1929 photoimmunotherapy (cetuximab sarotalocan) plus pembrolizumab
What this could lead to: If it works, this could offer a new first-line treatment option for people with recurrent head and neck cancer that hasn't spread, potentially improving survival.
What could go wrong: This is a phase 3 trial, but the combination is experimental. It may not prove better than current treatments, and photoimmunotherapy can cause side effects like pain, swelling, or skin reactions at the treatment site.

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Conditions

The condition(s) this trial relates to.

head and neck squamous cell carcinoma Squamous Cell Carcinoma of Head and Neck

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

RECURRENT HEAD AND NECK SQUAMOUS CELL CARCINOMA

Contacts and locations

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Study contacts

Contact

Email: •••••@•••••

Locations

Aichi Cancer Center
RECRUITING

Aichi, 464-8681, Japan
Avera Cancer Institute
RECRUITING

Sioux Falls, South Dakota, 57105, United States

Contact Email: •••••@•••••
Chi Mei Hospital
RECRUITING

Tainan, 736402, Taiwan
China Medical University
RECRUITING

Taichung, 404327, Taiwan
City of Hope
RECRUITING

Duarte, California, 91010, United States
Hiroshima University Hospital
RECRUITING

Hiroshima, 734-8551, Japan
Kaohsiung Medical University Chung-Ho Memorial Hospital
RECRUITING

Kaohsiung City, 807377, Taiwan
Kyoto Prefectural University of Medicine
RECRUITING

Kyoto, 602-8566, Japan
Linkou Chang Gung Memorial Hospital
RECRUITING

Taoyuan City, 333423, Taiwan
MacKay Memorial Hospital
RECRUITING

Taipei, 104217, Taiwan
National Taiwan University Hospital
RECRUITING

Taipei, 100225, Taiwan
Rhode Island Hospital
RECRUITING

Providence, Rhode Island, 02903, United States
Taichung Veterans General Hospital
RECRUITING

Taichung, 407219, Taiwan
Taipei Municipal Wanfang Hospital
RECRUITING

Taipei, 116081, Taiwan
Taipei Veterans General Hospital
RECRUITING

Taipei, 112201, Taiwan
Tampa General Hospital
RECRUITING

Tampa, Florida, 33606, United States
Thomas Jefferson University, Sidney Kimmel Cancer Center
RECRUITING

Philadelphia, Pennsylvania, 19107, United States
Tokyo Medical University Hospital
RECRUITING

Tokyo, 160-0023, Japan
Tottori University Hospital
RECRUITING

Yonago, 683-8504, Japan
University of Kentucky Medical Center
WITHDRAWN

Lexington, Kentucky, 40536, United States
University of Miami
RECRUITING

Miami, Florida, 33136, United States
University of Texas, MD Anderson Cancer Center
RECRUITING

Houston, Texas, 77030, United States

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