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.
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.
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
Parallel
ASP-1929 Photoimmunotherapy
Combination productASP-1929 IV infusion followed by illumination with light dose of 50 J/cm\^2 for superficial lesions and 100 J/cm for interstitial lesions within 24 +/- 4 hours after the end of ASP-1929 infusion (up to 24 months)
Pembrolizumab
Biological/Vaccine200 mg Q3W or 400 mg Q6W, IV infusion over 30 minutes (up to 24 months)
Carboplatin
DrugArea under the curve (AUC) 5 mg/mL/min IV infusion, Q3W up to 6 cycles
Cisplatin
Drug100 mg/m\^2 IV infusion, Q3W up to 6 cycles
5-fluorouracil
Drug1000 mg/m\^2 per day from Days 1-4 of each cycle, IV infusion, Q3W up to 6 cycles
Paclitaxel
Drug100 mg/m\^2 IV infusion given on Days 1 and 8, Q3W up to 6 cycles or 175 mg/m\^2 IV infusion given on Day 1, Q3W up to 6 cycles
Docetaxel
Drug75 mg/m\^2 IV Infusion, Q3W up to 6 cycles
Overall survival (OS)
OS is defined as the time from randomization until death due to any cause.
Complete response rate (CRR) per modified Response Evaluation Criteria in Solid Tumors, version 1.1 (RECIST 1.1) as assessed by central reviewer
CRR is defined as the proportion of patients with best overall response of confirmed CR
Overall response rate (ORR) per modified RECIST 1.1 as assessed by central reviewer
ORR is defined as the proportion of patients with best overall response of confirmed CR or confirmed partial response (PR)
Progression-free survival (PFS) per modified RECIST 1.1 as assessed by central reviewer
PFS is defined as the time from randomization to the first documented tumor progression or death due to any cause, whichever occurs first.
OS rates at 12, 18, and 24 months
OS rates at 12, 18, and 24 months are defined as the proportions of patients who are alive at these time points
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