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Combining ASP-1929 photoimmunotherapy with pembrolizumab for treating recurrent head and neck cancer

A Phase 3 Multicenter, Randomized, Open-label Study of ASP-1929 Photoimmunotherapy in Combination With Pembrolizumab Versus Standard of Care in the First-line Treatment of Patients With Locoregional Recurrence of Squamous Cell Carcinoma of the Head and Neck (HNSCC) With No Distant Metastases

Phase 3 Interventional Rakuten Medical, Inc. · NCT06699212

This study is testing if a new light-based treatment combined with pembrolizumab can help people with recurring head and neck cancer live longer compared to standard treatments.

Quick facts

PhasePhase 3
Study typeInterventional
Enrollment412 (estimated)
Ages18 Years and up
SexAll
SponsorRakuten Medical, Inc. Industry-sponsored
Drugs / interventionspembrolizumab, cetuximab, chemotherapy, radiation, prednisone
Locations22 sites (Duarte, California and 21 other locations)
Trial IDNCT06699212 on ClinicalTrials.gov

What this trial studies

This clinical trial evaluates the effectiveness and safety of ASP-1929 photoimmunotherapy (PIT) in combination with pembrolizumab for patients with locoregional recurrent squamous cell carcinoma of the head and neck that has not spread to distant sites. Participants will be randomly assigned to receive either the combination treatment or standard of care, which includes pembrolizumab alone or with chemotherapy. The study aims to determine if the combination therapy improves overall survival compared to the control group. An interim analysis will be conducted to optimize dosing during the trial.

Who should consider this trial

Good fit: Ideal candidates are adults with recurrent head and neck squamous cell carcinoma who have not experienced distant metastases and are eligible for first-line treatment.

Not a fit: Patients with distant metastatic disease or those who have previously received anti-PD-1 or anti-PD-L1 treatments may not benefit from this study.

Why it matters

Potential benefit: If successful, this treatment could significantly improve survival rates for patients with recurrent head and neck cancer.

How similar studies have performed: Other studies have shown promising results with similar immunotherapy approaches, indicating potential for success in this trial.

Eligibility criteria

Show full inclusion / exclusion criteria 
Inclusion Criteria:

* 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 Criteria:

* 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 this trial is running

Duarte, California and 21 other locations

Study contacts

How to participate

  1. Review the eligibility criteria above with your treating physician.
  2. Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
  3. Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
View on ClinicalTrials.gov → Find more trials like this →
Conditions Recurrent Head and Neck Squamous Cell CarcinomaHNSCCSquamous Cell Carcinoma of Head and NeckHead and Neck Squamous Cell CarcinomaOral Cavity Squamous Cell CarcinomaSquamous Cell Carcinoma of the Head and Neckimmunotherapymedical device
Last reviewed 2026-06-13 by the Find a Trial editorial team. Information on this page is for educational purposes and is not medical advice. Always consult qualified healthcare professionals about clinical trial participation.