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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
NCT06699212 · View on ClinicalTrials.gov ↗
Study Summary
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 Studied
Interventions
- BIOLOGICAL Pembrolizumab
- DRUG Carboplatin
- DRUG Cisplatin
- DRUG 5-fluorouracil
- COMBINATION_PRODUCT ASP-1929 Photoimmunotherapy
Study Locations (20)
Other
- Aichi Cancer Center — Aichi
- Hiroshima University Hospital — Hiroshima
- Kyoto Prefectural University of Medicine — Kyoto
- Tokyo Medical University Hospital — Tokyo
- Tottori University Hospital — Yonago
- Kaohsiung Medical University Chung-Ho Memorial Hospital — Kaohsiung City
- China Medical University — Taichung
- Taichung Veterans General Hospital — Taichung
- Chi Mei Hospital — Tainan
- National Taiwan University Hospital — Taipei
- MacKay Memorial Hospital — Taipei
- Taipei Veterans General Hospital — Taipei
Florida
- University of Miami — Miami
- Tampa General Hospital — Tampa
California
- City of Hope — Duarte
Kentucky
- University of Kentucky Medical Center — Lexington
Pennsylvania
- Thomas Jefferson University, Sidney Kimmel Cancer Center — Philadelphia
Rhode Island
- Rhode Island Hospital — Providence
South Dakota
- Avera Cancer Institute — Sioux Falls
Texas
- University of Texas, MD Anderson Cancer Center — Houston
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 412 participants |
| Start Date | 2024-12-24 |
| Est. Completion | 2028-09 |
| Phase | Phase 3 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT06699212
The ClinicalTrials.gov registry entry for NCT06699212 describes a study currently listed as recruiting. It is categorized as Phase 3, which is the standard way researchers label where a study sits along the investigational pathway from early safety work through later efficacy and post-marketing evaluation. The registered enrollment target is 412 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Rakuten Medical, which has 4 total studies on file at ClinicalTrials.gov, and sponsors are the parties responsible for study design, oversight, and regulatory filings.
The record links to 1 condition, with Recurrent Head and Neck Squamous Cell Carcinoma appearing as the primary indexed condition, and to 5 interventions — of which Pembrolizumab is the first listed. Interventions can include drugs, devices, procedures, behavioral programs, or observational arms, and each is tracked as a separate registry field so that downstream queries can filter accurately. When a trial lists multiple interventions, it usually reflects a multi-arm design or a comparison protocol rather than a single treatment being tested in isolation. The brief summary published in the registry is the clearest source of protocol intent and should be read before drawing conclusions from any sidebar tags.
Geographic footprint matters for practical reasons: NCT06699212 reports 20 study locations spanning 8 distinct geographic areas — top geographies include Other, Florida, California. A larger site network tends to correlate with broader recruitment capacity, but it does not imply anything about study quality, and site-level enrollment status can diverge from the overall registry status shown above. Every data point on this page comes from the public ClinicalTrials.gov dataset and is reproduced here for reference only; it is not a medical recommendation, an endorsement of the sponsor, or an invitation to enroll. Verify current status, eligibility criteria, and contact details directly at ClinicalTrials.gov, and discuss any participation decision with your own healthcare provider.
Frequently Asked Questions
What is clinical trial NCT06699212 about?
NCT06699212 is a clinical study titled "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". 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 pembrolizu...
What is the current status of trial NCT06699212?
This trial is currently recruiting. It is a Phase 3 study. The enrollment target is 412 participants. The study started on 2024-12-24. Estimated completion is 2028-09.
What conditions does trial NCT06699212 study?
This clinical trial studies the following conditions: Recurrent Head and Neck Squamous Cell Carcinoma. These conditions were identified from the trial registry and reflect the primary focus areas of the research.
What interventions are being tested in trial NCT06699212?
The interventions under investigation include: Pembrolizumab (BIOLOGICAL), Carboplatin (DRUG), Cisplatin (DRUG), 5-fluorouracil (DRUG), ASP-1929 Photoimmunotherapy (COMBINATION_PRODUCT). Each intervention is being evaluated for safety and efficacy as part of this clinical study.
Who is sponsoring clinical trial NCT06699212?
This trial is sponsored by Rakuten Medical, which has 4 total clinical trials registered on ClinicalTrials.gov. The sponsor is responsible for the study's design, funding, and regulatory compliance.
Where is trial NCT06699212 being conducted?
This trial has 20 study locations across California, Florida, Kentucky, Pennsylvania, Rhode Island. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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