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

Recruiting now · Phase 3

Conditions studied: Recurrent Head and Neck Squamous Cell Carcinoma

In brief

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.

Key facts

Study ID: NCT06699212
Run by: Rakuten Medical, Inc.
People needed: 412
Starts: 2024-12-24
Expected to finish: 2028-09-01
Last updated by the study team: 2025-10-15

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

Histological or cytological evidence of squamous cell carcinoma of a head and neck primary site (per American Joint Committee on Cancer [AJCC], other than nasopharynx or cuSCC).
Appropriate for SOC first-line treatment of their recurrent head and neck cancer with pembrolizumab ± chemotherapy.
No known history of any distant metastatic disease (M1 by AJCC eighth edition).
Tumors with at least one PIT-accessible and RECIST 1.1 measurable lesion as assessed by investigator.
Anti-PD-1 and anti-PD-L1-treatment naïve.
Combined positive score (CPS) ≥ 1 as determined locally by an FDA-approved test
Have results from testing of human papillomavirus (HPV) status for oropharyngeal cancer
Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1 at the time of screening
Adequate hematologic, renal, and hepatic organ function
Women of childbearing potential (WOCBP) must have a negative pregnancy test at screening and must be willing to use a highly effective birth control while on study or be surgically sterile or abstain from heterosexual sexual activity for the course of the study through 180 days after the last dose of study treatment. Male patients must agree to use a highly effective method of contraception starting with the first dose of study medication through 120 days after the last dose of study treatment.

You may not qualify if…

Diagnosed and/or treated for additional malignancy within 2 years before randomization except for those with a negligible risk of metastasis or death (such as adequately treated carcinoma in situ of the cervix, basal cell skin cancer, localized prostate cancer, or ductal carcinoma in situ). Patients with a history of other prior cancer treated with complete surgical resection and with no evidence of disease may be eligible based on discussion with the Medical Monitor.
History of significant (Grade ≥ 3) cetuximab infusion reactions
Prior allogeneic tissue/solid organ transplant
Known or active central nervous system metastases and/or carcinomatous meningitis
Life expectancy of less than 3 months
Active autoimmune disease that has required systemic treatment in past 2 years (i.e., with use of disease modifying agents, corticosteroids, or immunosuppressive drugs); replacement therapy (e.g., thyroxine, insulin, or physiologic corticosteroid replacement therapy for adrenal or pituitary insufficiency) is not considered a form of systemic treatment.
Evidence of interstitial lung disease or current active, noninfectious pneumonitis
Active infection requiring systemic therapies such as antibiotic, antifungal, or antiviral intervention
Known or active bacterial, viral, or fungal infection including tuberculosis, Hepatitis B (e.g., HBV DNA is detected), or Hepatitis C (e.g., RNA [qualitative] is detected)
Known history of testing positive for human immunodeficiency virus or acquired immunodeficiency syndrome (AIDS)-related illness
Prior or ongoing Grade ≥ 3 tumor hemorrhage within 12 weeks of randomization
Uncontrolled intercurrent illness including, but not limited to, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia, or psychiatric illness/social situations that would limit compliance with study requirements
Prior systemic chemotherapy or targeted small molecule therapy or radiation therapy within 2 weeks of C1D1 or has not recovered (i.e., Grade ≤ 1 or at baseline) from adverse events (AEs) due to previously administered agent
Prior anticancer monoclonal antibody therapy or investigational agent or intervention within 4 weeks of C1D1 or has not recovered (i.e., Grade ≤ 1 or at baseline) from AEs due to previously administered agent
Prior receipt of ASP-1929 at any time
Receiving chronic systemic steroid therapy (in doses exceeding 10 mg per day of prednisone equivalent) or any other form of immunosuppressive therapy within 14 days prior to randomization
Received a live vaccine within 4 weeks of randomization; seasonal influenza vaccines for injection are generally inactivated flu vaccines and are allowed; however intranasal influenza vaccines (e.g., Flu-Mist®) are live attenuated vaccines, and are not allowed
Requiring future examinations or treatments within 4 weeks after an ASP-1929 PIT treatment exposing the patient to significant light (e.g., eye examinations, surgical procedures, endoscopy) that is unrelated to the ASP-1929 PIT treatment
Major surgery or significant traumatic injury within 4 weeks before randomization, or anticipation of the need for major surgery during the course of study treatment

Where it is running

Linkou Chang Gung Memorial Hospital — Taoyuan City, Taiwan (enrolling)
University of Miami — Miami, Florida, United States (enrolling)
Tampa General Hospital — Tampa, Florida, United States (enrolling)
City of Hope — Duarte, California, United States (enrolling)
Thomas Jefferson University, Sidney Kimmel Cancer Center — Philadelphia, Pennsylvania, United States (enrolling)
Rhode Island Hospital — Providence, Rhode Island, United States (enrolling)
Avera Cancer Institute — Sioux Falls, South Dakota, United States (enrolling)
University of Texas, MD Anderson Cancer Center — Houston, Texas, United States (enrolling)
Aichi Cancer Center — Aichi, Japan (enrolling)
Hiroshima University Hospital — Hiroshima, Japan (enrolling)
Kyoto Prefectural University of Medicine — Kyoto, Japan (enrolling)
Tokyo Medical University Hospital — Tokyo, Japan (enrolling)
Tottori University Hospital — Yonago, Japan (enrolling)
Kaohsiung Medical University Chung-Ho Memorial Hospital — Kaohsiung City, Taiwan (enrolling)
China Medical University — Taichung, Taiwan (enrolling)
Taichung Veterans General Hospital — Taichung, Taiwan (enrolling)
Chi Mei Hospital — Tainan, Taiwan (enrolling)
National Taiwan University Hospital — Taipei, Taiwan (enrolling)
MacKay Memorial Hospital — Taipei, Taiwan (enrolling)
Taipei Veterans General Hospital — Taipei, Taiwan (enrolling)
Taipei Municipal Wanfang Hospital — Taipei, Taiwan (enrolling)
University of Kentucky Medical Center — Lexington, Kentucky, United States

Full record on ClinicalTrials.gov

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