Actively Recruiting
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
Led by Rakuten Medical, Inc. · Updated on 2025-10-15
412
Participants Needed
22
Research Sites
192 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official 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 the head and neck (excluding nasopharynx or cutaneous SCC).
- Suitable for first-line standard treatment with pembrolizumab with or without chemotherapy.
- No known distant metastatic disease.
- Tumor has at least one measurable lesion accessible to photoimmunotherapy.
- No prior treatment with anti-PD-1 or anti-PD-L1 therapies.
- Combined positive score (CPS) of 1 or higher by FDA-approved local test.
- HPV status results available for oropharyngeal cancer.
- ECOG performance status of 0 or 1 at screening.
- Adequate blood, kidney, and liver function.
- Women of childbearing potential must have a negative pregnancy test and agree to effective contraception during study and for 180 days after last dose; male patients must agree to effective contraception during study and for 120 days after last dose.
You will not qualify if you...
- Diagnosed or treated for another cancer within 2 years before randomization, except for low-risk cancers or fully treated cancers without disease evidence.
- History of severe (Grade 3 or higher) cetuximab infusion reactions.
- Prior allogeneic tissue or organ transplant.
- Known or active brain metastases or carcinomatous meningitis.
- Life expectancy less than 3 months.
- Active autoimmune disease needing systemic treatment in past 2 years.
- Evidence of interstitial lung disease or active noninfectious pneumonitis.
- Active infection requiring systemic antibiotics, antifungals, or antivirals.
- Known positive for HIV/AIDS.
- Prior or ongoing Grade 3 or higher tumor bleeding within 12 weeks before randomization.
- Uncontrolled illnesses such as heart failure, unstable angina, arrhythmia, or psychiatric/social conditions limiting compliance.
- Recent chemotherapy, targeted therapy, monoclonal antibody, investigational treatment, or radiation within 2 to 4 weeks before starting study without recovery.
- Prior treatment with ASP-1929.
- Use of systemic steroids above 10 mg prednisone equivalent or other immunosuppressive therapy within 14 days prior to randomization.
- Received live vaccine within 4 weeks before randomization (some influenza vaccines allowed).
- Expected need for procedures involving significant light exposure within 4 weeks after ASP-1929 treatment unrelated to study.
- Major surgery or serious injury within 4 weeks before randomization or expected during study treatment.
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
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
CONTACT
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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