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)
A Phase 3 Multicenter, Randomized, Open-label Study of ASP-1929 Photoimmunotherapy in Combination With Pembrolizumab Versus Standard of Care in the First-line Treatment of Patients With Locoregional Recurrence of Squamous Cell Carcinoma of the Head and Neck (HNSCC) With No Distant Metastases
🩺 Plain-English Summary (8th-Grade Level)
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.
Who can join: Review the eligibility criteria below.
Location: City of Hope — Duarte, California
Age range: 18 Years
🧪 Interventions in This Study
📋 "Do I Qualify?" — 1-Minute Self Screener
Instant ChecklistFull eligibility criteria are available on the official NIH protocol. View the criteria ↗
📍 All Participating Trial Locations (22 Sites)
- City of Hope — Duarte, California
- University of Miami — Miami, Florida
- Tampa General Hospital — Tampa, Florida
- University of Kentucky Medical Center — Lexington, Kentucky
- Thomas Jefferson University, Sidney Kimmel Cancer Center — Philadelphia, Pennsylvania
- Rhode Island Hospital — Providence, Rhode Island
- Avera Cancer Institute — Sioux Falls, South Dakota
- University of Texas, MD Anderson Cancer Center — Houston, Texas
- 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,
- Taipei Municipal Wanfang Hospital — Taipei,
- Linkou Chang Gung Memorial Hospital — Taoyuan City,
📞 Contact the Study Coordinator
Phone: (858) 207-3113
Email: clinicaltrialinfo@rakuten-med.com
Coordinator details come directly from the registered NIH protocol. Confirm the study is still recruiting before traveling.
💰 Cost, Insurance & Patient Rights
- 100% Free Items: The investigational treatment and protocol-required procedures are supplied at zero cost by the sponsor.
- Routine Patient Care: Under federal law (ACA § 2709) and many state statutes, routine care costs are covered during participation.
- Voluntary Participation: You may withdraw at any time without affecting your standard medical care.
More studies in Recurrent Head and Neck Squamous Cell Carcinoma
- An Open-label Study Using ASP-1929 Photoimmunotherapy in Combination With Anti-PD1 Therapy in EGFR Expressing Advanced Solid Tumors — Miami, Florida
- Olaparib in Combination With Pembrolizumab and Carboplatin as First-Line Treatment of Recurrent or Metastatic Head and Neck Squamous-Cell Carcinoma — St Louis, Missouri
- Testing What Happens When an Immunotherapy Drug (Pembrolizumab) is Given by Itself Compared to the Usual Treatment of Chemotherapy With Radiation After Surgery for Recurrent Head and Neck Squamous Cell Carcinoma — Birmingham, Alabama
Explore by condition: All Recurrent Head and Neck Squamous Cell Carcinoma clinical trials
💡 How to Participate
- Check the checklist above to see if you may qualify.
- Contact the study coordinator using the phone/email above.
- Ask about the visit schedule, what is covered at no cost, and any travel support.
- Confirm with your own doctor before making a decision.