OncoMatch/Clinical Trials/NCT06699212
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
Is NCT06699212 recruiting? Yes, currently enrolling (May 2026). This Phase 3 trial studies multiple treatments for recurrent head and neck squamous cell carcinoma.
Treatment: ASP-1929 Photoimmunotherapy · Pembrolizumab · Carboplatin · Cisplatin · 5-fluorouracil · Paclitaxel · Docetaxel — 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.
Check if I qualifyExtracted eligibility criteria
Cancer type
Head and Neck Squamous Cell Carcinoma
Biomarker criteria
Required: PD-L1 (CD274) combined positive score (CPS) ≥ 1 (CPS ≥ 1)
Combined positive score (CPS) ≥ 1 as determined locally by an FDA-approved test
Performance status
ECOG 0–1(Restricted strenuous activity)
Prior therapy
Cannot have received: anti-PD-1 therapy
Anti-PD-1 and anti-PD-L1-treatment naïve
Cannot have received: anti-PD-L1 therapy
Anti-PD-1 and anti-PD-L1-treatment naïve
Cannot have received: systemic chemotherapy
Exception: within 2 weeks of C1D1 or not recovered (i.e., Grade ≤ 1 or at baseline) from adverse events
Prior systemic chemotherapy or targeted small molecule therapy or radiation therapy within 2 weeks of C1D1 or has not recovered (i.e., Grade ≤ 1 or at baseline) from adverse events (AEs) due to previously administered agent
Cannot have received: targeted small molecule therapy
Exception: within 2 weeks of C1D1 or not recovered (i.e., Grade ≤ 1 or at baseline) from adverse events
Prior systemic chemotherapy or targeted small molecule therapy or radiation therapy within 2 weeks of C1D1 or has not recovered (i.e., Grade ≤ 1 or at baseline) from adverse events (AEs) due to previously administered agent
Cannot have received: radiation therapy
Exception: within 2 weeks of C1D1 or not recovered (i.e., Grade ≤ 1 or at baseline) from adverse events
Prior systemic chemotherapy or targeted small molecule therapy or radiation therapy within 2 weeks of C1D1 or has not recovered (i.e., Grade ≤ 1 or at baseline) from adverse events (AEs) due to previously administered agent
Cannot have received: anticancer monoclonal antibody therapy
Exception: within 4 weeks of C1D1 or not recovered (i.e., Grade ≤ 1 or at baseline) from adverse events
Prior anticancer monoclonal antibody therapy or investigational agent or intervention within 4 weeks of C1D1 or has not recovered (i.e., Grade ≤ 1 or at baseline) from AEs due to previously administered agent
Cannot have received: investigational agent or intervention
Exception: within 4 weeks of C1D1 or not recovered (i.e., Grade ≤ 1 or at baseline) from adverse events
Prior anticancer monoclonal antibody therapy or investigational agent or intervention within 4 weeks of C1D1 or has not recovered (i.e., Grade ≤ 1 or at baseline) from AEs due to previously administered agent
Cannot have received: ASP-1929 (ASP-1929)
Prior receipt of ASP-1929 at any time
Lab requirements
Blood counts
Kidney function
Liver function
Structured fields extracted by AI. May contain errors — verify against the official protocol.
US trial 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
Showing up to 5 US sites. See all sites on ClinicalTrials.gov →
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