NCT06699212 · Rakuten Medical, Inc.
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
(ECLIPSE)
What this study 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.
View original scientific description
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.
Interventions
COMBINATION_PRODUCT
ASP-1929 Photoimmunotherapy
ASP-1929 IV infusion followed by illumination with light dose of 50 J/cm\^2 for superficial lesions and 100 J/cm for interstitial lesions within 24 +/- 4 hours after the end of ASP-1929 infusion (up to 24 months)
BIOLOGICAL
Pembrolizumab
200 mg Q3W or 400 mg Q6W, IV infusion over 30 minutes (up to 24 months)
DRUG
Carboplatin
Area under the curve (AUC) 5 mg/mL/min IV infusion, Q3W up to 6 cycles
DRUG
Cisplatin
100 mg/m\^2 IV infusion, Q3W up to 6 cycles
DRUG
5-fluorouracil
1000 mg/m\^2 per day from Days 1-4 of each cycle, IV infusion, Q3W up to 6 cycles
DRUG
Paclitaxel
100 mg/m\^2 IV infusion given on Days 1 and 8, Q3W up to 6 cycles or 175 mg/m\^2 IV infusion given on Day 1, Q3W up to 6 cycles
DRUG
Docetaxel
75 mg/m\^2 IV Infusion, Q3W up to 6 cycles
Primary outcome measures
Overall survival (OS)
Time frame: Up to approximately 48 months
OS is defined as the time from randomization until death due to any cause.
Who can participate
This study lists these criteria on ClinicalTrials.gov. A study coordinator reviews eligibility during screening — this page does not determine whether you qualify.
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 h
Where
- Duarte, California
- Miami, Florida
- Tampa, Florida
- Lexington, Kentucky
- Philadelphia, Pennsylvania
- Providence, Rhode Island
- Sioux Falls, South Dakota
- Houston, Texas
Related conditions & keywords
Frequently asked questions
What is a clinical trial?
A clinical trial is a research study that tests new medical treatments, drugs, devices, or procedures to determine their safety and effectiveness. Trials are carefully designed and monitored to protect participants while advancing medical knowledge.
Is it safe to participate?
Clinical trials follow strict safety guidelines and ethical standards. Trials must be reviewed and approved, and participants are closely monitored by medical professionals throughout the study. You can withdraw at any time if you choose.
Will I be compensated?
Many clinical trials offer compensation for your time, travel expenses, and inconvenience. The specific compensation varies by study and will be discussed during the screening process. All study-related medical care is typically provided at no cost to participants.
Will I receive a placebo instead of treatment?
When effective treatment exists, participants typically receive either the standard treatment plus the study intervention, or the standard treatment plus placebo. You would not be denied effective care. Placebos are primarily used when no proven treatment is available, or in addition to standard care. Your trial consent form will clearly explain what treatments you may receive.
Can I leave a trial if I change my mind?
Absolutely. Participation in clinical trials is completely voluntary. You have the right to withdraw from the study at any time, for any reason, without penalty or loss of benefits to which you are otherwise entitled.
How long does a clinical trial last?
Trial duration varies widely depending on the study design and purpose. Some trials last just a few weeks, while others may continue for months or years. The study coordinator will provide specific timeline information during your screening call.
Data: ClinicalTrials.gov · synced Oct 15, 2025 · Source of record for eligibility and locations