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NCT06699212 · ClinicalTrials.gov registry record · Phase 3
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
A Phase 3 study of Recurrent Head and Neck Squamous Cell Carcinoma, sponsored by Rakuten Medical.
- Recruiting
- Registry status
- Phase 3
- Development phase
- 412
- Enrollment target
- 20
- Study locations
NCT06699212: Recruiting Phase 3 study of Recurrent Head and Neck Squamous Cell Carcinoma, sponsored by Rakuten Medical.
NCT06699212 is a Phase 3 study of Recurrent Head and Neck Squamous Cell Carcinoma that is actively recruiting participants, run by Rakuten Medical. The registered enrollment target is 412 participants, above the 103-participant average among 24 other Recurrent Head and Neck Squamous Cell Carcinoma trials with a reported enrollment target (300% higher). The trial reports 20 study locations across 8 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT06699212, a Phase 3 study of Recurrent Head and Neck Squamous Cell Carcinoma, is actively recruiting participants, sponsored by Rakuten Medical.
- RECRUITING
- Registry status
- Phase 3
- Development phase
- 412 participants
- Enrollment target
- 20
- Study locations
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.
Primary Outcome
OS is defined as the time from randomization until death due to any cause.
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 |
What NCT06699212 shows while recruiting
NCT06699212 is an interventional study that assigns participants to a tested intervention. The registered 412 participants enrollment target is mid-sized for trials with a published cap, above the 103-participant average among 24 other Recurrent Head and Neck Squamous Cell Carcinoma trials with a reported enrollment target (300% higher).
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.
NCT06699212 names 20 study sites across 8 states, led by Other, Florida, California.
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.
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).
Who is sponsoring clinical trial NCT06699212?
This trial is sponsored by Rakuten Medical, which has 5 total clinical trials registered on ClinicalTrials.gov.
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.
Learn More About Clinical Trials
Similar trials for Recurrent Head and Neck Squamous Cell Carcinoma
Matched on the same primary condition, ranked to surface studies in the same phase first, then by recruiting status, no relevance scoring or editorial curation.
Where NCT06699212's enrollment target sits among peer trials
412 3rd of 24 higher than 22 of 24 other Recurrent Head and Neck Squamous Cell Carcinoma trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Recurrent Head and Neck Squamous Cell Carcinoma trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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