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 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 bein

Trial Details

NCT ID
NCT06699212
Phase
PHASE3
Sponsor
Rakuten Medical, Inc.
Status
RECRUITING
Cancer Type
Head and Neck Cancer
Interventions
  • ASP-1929 Photoimmunotherapy
  • Pembrolizumab
  • Carboplatin
  • Cisplatin
  • 5-fluorouracil
  • Paclitaxel
Locations (sample)
  • Duarte, California, United States|34.13945,-117.97729
  • Miami, Florida, United States|25.77427,-80.19366
  • Tampa, Florida, United States|27.94752,-82.45843
  • Lexington, Kentucky, United States|37.98869,-84.47772
  • Philadelphia, Pennsylvania, United States|39.95238,-75.16362

Key Eligibility Criteria

  • Histological or cytological evidence of squamous cell carcinoma of a head and neck primary site (per American Joint Committee on Cancer \[AJCC\], o…
  • 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.

For full eligibility, visit ClinicalTrials.gov.

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