Actively Recruiting
A Study of ASP-1929 Photoimmunotherapy Combined With Pembrolizumab Versus Standard Care for First-Line Treatment of Locoregional Recurrent Squamous Cell Carcinoma of the Head and Neck Without Distant Metastases
Led by Rakuten Medical, Inc. · Updated on 2025-10-15
412
Participants Needed
22
Research Sites
N/A
Total Duration
On this page
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 2:2:1 ratio to one of three treatment groups: ASP-1929 PIT at a dose of 320 mg/m² plus pembrolizumab, ASP-1929 PIT at 640 mg/m² plus pembrolizumab, or a control group receiving standard care with either pembrolizumab alone or pembrolizumab plus chemotherapy according to the physician's 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
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.
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - Up to 24 months
Participants receive assigned treatments which may include ASP-1929 photoimmunotherapy combined with pembrolizumab or standard care treatments involving pembrolizumab alone or with chemotherapy. Treatments are administered through intravenous infusions and photoimmunotherapy light illumination. Treatment duration is up to 24 months.
Pembrolizumab infusions every 3 weeks for the first 6 cycles, then every 6 weeks as decided by the investigator; ASP-1929 photoimmunotherapy repeated every 4 to 6 weeks depending on clinical judgement; chemotherapy (if assigned) given every 3 weeks for up to 6 cycles
Duration - Up to approximately 48 months
Participants are monitored for safety and long-term outcomes after completion or discontinuation of treatment.
Visits scheduled according to study protocol for survival and response assessments
Trial Site Locations
Total: 22 locations
1
City of Hope
Duarte, California, United States, 91010
Actively Recruiting
2
University of Miami
Miami, Florida, United States, 33136
Actively Recruiting
3
Tampa General Hospital
Tampa, Florida, United States, 33606
Actively Recruiting
4
University of Kentucky Medical Center
Lexington, Kentucky, United States, 40536
Withdrawn
5
Thomas Jefferson University, Sidney Kimmel Cancer Center
Philadelphia, Pennsylvania, United States, 19107
Actively Recruiting
6
Rhode Island Hospital
Providence, Rhode Island, United States, 02903
Actively Recruiting
7
Avera Cancer Institute
Sioux Falls, South Dakota, United States, 57105
Actively Recruiting
8
University of Texas, MD Anderson Cancer Center
Houston, Texas, United States, 77030
Actively Recruiting
9
Aichi Cancer Center
Aichi, Japan, 464-8681
Actively Recruiting
10
Hiroshima University Hospital
Hiroshima, Japan, 734-8551
Actively Recruiting
11
Kyoto Prefectural University of Medicine
Kyoto, Japan, 602-8566
Actively Recruiting
12
Tokyo Medical University Hospital
Tokyo, Japan, 160-0023
Actively Recruiting
13
Tottori University Hospital
Yonago, Japan, 683-8504
Actively Recruiting
14
Kaohsiung Medical University Chung-Ho Memorial Hospital
Kaohsiung City, Taiwan, 807377
Actively Recruiting
15
China Medical University
Taichung, Taiwan, 404327
Actively Recruiting
16
Taichung Veterans General Hospital
Taichung, Taiwan, 407219
Actively Recruiting
17
Chi Mei Hospital
Tainan, Taiwan, 736402
Actively Recruiting
18
National Taiwan University Hospital
Taipei, Taiwan, 100225
Actively Recruiting
19
MacKay Memorial Hospital
Taipei, Taiwan, 104217
Actively Recruiting
20
Taipei Veterans General Hospital
Taipei, Taiwan, 112201
Actively Recruiting
21
Taipei Municipal Wanfang Hospital
Taipei, Taiwan, 116081
Actively Recruiting
22
Linkou Chang Gung Memorial Hospital
Taoyuan City, Taiwan, 333423
Actively Recruiting
Research Team
A
ASP-1929-381 Study Team
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
3
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