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
Eligible age
18+ yrs
Accepts
All genders
Locations
7 states
Healthy volunteers
No
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About this study
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.
Sponsor: Rakuten Medical, Inc.
You may qualify if…
- ✓ Histological or cytological evidence of squamous cell carcinoma of a head and neck primary site (per American Joint Committee on Cancer \[AJCC\], other than nasopharynx or cuSCC).
- ✓ 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.
- ✓ Anti-PD-1 and anti-PD-L1-treatment naïve.
- ✓ Combined positive score (CPS) ≥ 1 as determined locally by an FDA-approved test
- ✓ Have results from testing of human papillomavirus (HPV) status for oropharyngeal cancer
- ✓ Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1 at the time of screening
You may not qualify if…
- ✕ Diagnosed and/or treated for additional malignancy within 2 years before randomization except for those with a negligible risk of metastasis or death (such as adequately treated carcinoma in situ of the cervix, basal cell skin cancer, localized prostate cancer, or ductal carcinoma in situ). Patients with a history of other prior cancer treated with complete surgical resection and with no evidence of disease may be eligible based on discussion with the Medical Monitor.
- ✕ History of significant (Grade ≥ 3) cetuximab infusion reactions
- ✕ Prior allogeneic tissue/solid organ transplant
- ✕ Known or active central nervous system metastases and/or carcinomatous meningitis
- ✕ Life expectancy of less than 3 months
- ✕ Active autoimmune disease that has required systemic treatment in past 2 years (i.e., with use of disease modifying agents, corticosteroids, or immunosuppressive drugs); replacement therapy (e.g., thyroxine, insulin, or physiologic corticosteroid replacement therapy for adrenal or pituitary insufficiency) is not considered a form of systemic treatment.
- ✕ Evidence of interstitial lung disease or current active, noninfectious pneumonitis
- ✕ Active infection requiring systemic therapies such as antibiotic, antifungal, or antiviral intervention
Where it's recruiting
Duarte
Miami · Tampa
Lexington
Philadelphia
Providence
Sioux Falls
Houston
Source: ClinicalTrials.gov · NCT06699212 · last updated 2025-10-15