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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 of ASP-1929 Photoimmunotherapy and Pembrolizumab for Recurrent Head and Neck Cancer", "This study is testing a new combination treatment for recurrent head and neck squamous cell carcinoma (HNSCC) that has not spread to distant parts of the body. Researchers want to see if combining ASP-1929 photoimmunotherapy (a treatment using light to activate a drug) with pembrolizumab (an immunotherapy drug) is more effective than pembrolizumab alone or pembrolizumab with chemotherapy. The main goal is to find out if this combination improves how long people live (overall survival). You may be eligible if you have HNSCC that has come back and are suitable for standard first-line treatment with pembrolizumab, with or without chemotherapy. The study is currently recruiting about 412 participants, but its exact status is unclear.", "design": "This is a randomized study, meaning participants are assigned by chance to one of three treatment groups: ASP-1929 photoimmunotherapy with pembrolizumab (at two different doses) or standard of care (pembrolizumab alone or with chemotherapy).", "commitments": "You would receive ASP-1929 via IV infusion followed by light treatment, and pembrolizumab via IV infusion, for up to 24 months. If in the standard of care group, you would receive pembrolizumab and/or chemotherapy (carboplatin, cisplatin, or 5-fluorouracil) via IV infusion for up to 6 cycles.", "compensation": "Not stated in the trial record.", "follow_up": "Your overall survival will be measured for up to approximately 48 months after treatment.", }

Study design
Not specified.
What's involved
Not specified in the trial record.
Compensation
Not stated in the trial record.
Follow-up
Not specified.

AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.

NCT06699212

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
PHASE3Ages 18+InterventionalTreatment
Rakuten Medical, Inc.
~412 participants
Updated 2025-10-15 on ClinicalTrials.gov
What's tested:ASP-1929 PhotoimmunotherapyPembrolizumabCarboplatinCisplatin5-fluorouracilPaclitaxel

At a glance

Recruiting sites
21 of 22 listed sites are recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Overall survival (OS)
Measured over Up to approximately 48 months

Conditions

Recurrent Head and Neck Squamous Cell Carcinoma

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Head and Neck Squamous Cell CarcinomaHPVProgrammed Cell Death 1 Ligand 1Programmed Cell Death Protein 1Soluble Epidermal Growth Factor Receptor

Where it's being run

22 sites across 9 states
Taiwan9
Japan5
Florida2
California1
Kentucky1
Pennsylvania1
Rhode Island1
South Dakota1

Study leadership

  • Ethan Chen, MD · STUDY_DIRECTOR · Rakuten Medical, Inc.
  • Rebecca Cheng, MD · STUDY_DIRECTOR · Rakuten Medical, Inc.

Who to contact

ASP-1929-381 Study Team
[email protected]
858-207-3113
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Eligibility criteria

Inclusion

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.

Exclusion

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

What this trial measures

  • Overall survival (OS)Up to approximately 48 months

    OS is defined as the time from randomization until death due to any cause.