What is ASP-1929 photoimmunotherapy studying for head and neck squamous cell carcinoma?

ASP-1929 photoimmunotherapy is being studied in combination with pembrolizumab to see if it can improve survival for patients with recurrent head and neck squamous cell carcinoma without distant metastases. The trial compares this combination to pembrolizumab alone or with chemotherapy. Rakuten Medical, Inc. sponsors the study to assess both treatment effectiveness and safety.

Who may be eligible for this recurrent head and neck cancer clinical trial?

Adults 18 years or older with recurrent squamous cell carcinoma of the head and neck, no distant metastases, and no prior anti-PD-1 or anti-PD-L1 treatment may be eligible. Participants must have tumors accessible for photoimmunotherapy and good overall health. The trial accepts all genders. Please review eligibility criteria for more details.

Is there any cost to participate in this recurrent head and neck cancer clinical trial?

Study-related care, including the study drugs and all visits, is provided at no cost. However, personal travel expenses may vary and are not guaranteed to be covered. Participants should consider their own travel and accommodation costs when planning to join the trial.

Actively Recruiting

Phase 3

Age: 18Years +

All Genders

ID06699212

Phase 3 Study of ASP-1929 Photoimmunotherapy Plus Pembrolizumab Compared to Standard Treatment for Recurrent Head and Neck Squamous Cell Carcinoma Without Distant Spread

Led by Rakuten Medical, Inc. · Updated on 2025-10-15

412

Participants Needed

Research Sites

N/A

Total Duration

AI-Summary

What this Trial Is About

Researchers are evaluating whether combining ASP-1929 photoimmunotherapy PIT with pembrolizumab improves treatment outcomes for patients with locoregional recurrent squamous cell carcinoma of the head and neck HNSCC without distant metastases. This phase 3 randomized study aims to compare the effectiveness and safety of ASP-1929 PIT plus pembrolizumab against pembrolizumab alone or pembrolizumab combined with chemotherapy as first-line treatments. The main goal is to see if the combination improves overall survival for eligible patients. Participants will be randomly assigned in a 221 ratio to one of three treatment groups ASP-1929 PIT at a dose of 320 mgm plus pembrolizumab, ASP-1929 PIT at 640 mgm plus pembrolizumab, or a control group receiving standard care with either pembrolizumab alone or pembrolizumab plus chemotherapy according to the physicians choice. ASP-1929 PIT involves an intravenous infusion followed by illumination of the tumor with red light using a special laser system. Pembrolizumab is given as an intravenous infusion every 3 or 6 weeks. Chemotherapy options include carboplatin, cisplatin, 5-fluorouracil, paclitaxel, or docetaxel for up to 6 cycles. Treatment with ASP-1929 PIT and pembrolizumab may continue for up to 24 months. During the study, participants will undergo regular assessments including imaging evaluations to measure tumor response, safety monitoring for adverse events, and quality of life questionnaires. Researchers will track overall survival and other outcomes such as response rates and progression-free survival for up to about 48 months. Pharmacokinetic and immunogenicity tests will also be conducted in the experimental arms. Participants will have ongoing evaluations throughout the treatment period and follow-up to monitor effectiveness and safety.

CONDITIONS

Brief Title

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

Who Can Participate

Age: 18Years +

All Genders

Eligibility Criteria

You may qualify if you...

Histological or cytological proof of squamous cell carcinoma of a head and neck primary site (excluding nasopharynx or cutaneous squamous cell carcinoma).
Suitable for first-line standard treatment with pembrolizumab with or without chemotherapy.
No known distant metastatic disease (M1 by AJCC eighth edition).
Tumors must have at least one lesion accessible for photoimmunotherapy and measurable by RECIST 1.1.
No prior treatment with anti-PD-1 or anti-PD-L1 therapies.
Combined positive score (CPS) of 1 or higher by FDA-approved test.
HPV status results available for oropharyngeal cancer.
Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1.
Adequate blood, kidney, and liver function.
Women of childbearing potential must have a negative pregnancy test and agree to use effective birth control or abstain from heterosexual activity during the study and for 180 days after last dose.
Men must agree to use effective contraception from first dose through 120 days after last dose.

You will not qualify if you...

Diagnosis or treatment of another malignancy within 2 years before randomization except low-risk cancers or those surgically removed with no evidence of disease.
History of severe (Grade 3 or higher) reaction to cetuximab infusion.
Prior allogeneic tissue or solid organ transplant.
Known or active brain metastases or carcinomatous meningitis.
Life expectancy under 3 months.
Active autoimmune disease requiring systemic treatment within past 2 years.
Evidence of interstitial lung disease or active noninfectious pneumonitis.
Active infection needing systemic therapy.
Known infection with HIV, hepatitis B or C.
Recent Grade 3 or higher tumor bleeding within 12 weeks.
Uncontrolled serious illness or conditions limiting study compliance.
Recent chemotherapy, targeted therapy, radiation, monoclonal antibodies, or investigational agents within specified timeframes.
Prior receipt of ASP-1929.
Chronic systemic steroid or immunosuppressive therapy within 14 days before randomization.
Recent live vaccine within 4 weeks before randomization.
Planned examinations or treatments involving significant light exposure within 4 weeks after ASP-1929 PIT treatment.
Major surgery or severe injury within 4 weeks before randomization or planned during study treatment.

Research Team

ASP-1929-381 Study Team

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Phase 3 Study of ASP-1929 Photoimmunotherapy Plus Pembrolizumab Compared to Standard Treatment for Recurrent Head and Neck Squamous Cell Carcinoma Without Distant Spread

On this page

AI-Summary

What this Trial Is About

Brief Title

Who Can Participate

Eligibility Criteria

Research Team

Not the Right Trial for You?

On this page

Who Can Participate

Eligibility Criteria