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
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.
Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Healthy Volunteers: f
View:
• 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
• Adequate hematologic, renal, and hepatic organ function
• Women of childbearing potential (WOCBP) must have a negative pregnancy test at screening and must be willing to use a highly effective birth control while on study or be surgically sterile or abstain from heterosexual sexual activity for the course of the study through 180 days after the last dose of study treatment. Male patients must agree to use a highly effective method of contraception starting with the first dose of study medication through 120 days after the last dose of study treatment.
Locations
United States
California
City of Hope
RECRUITING
Duarte
Florida
University of Miami
RECRUITING
Miami
Tampa General Hospital
RECRUITING
Tampa
Kentucky
University of Kentucky Medical Center
WITHDRAWN
Lexington
Pennsylvania
Thomas Jefferson University, Sidney Kimmel Cancer Center
RECRUITING
Philadelphia
Rhode Island
Rhode Island Hospital
RECRUITING
Providence
South Dakota
Avera Cancer Institute
RECRUITING
Sioux Falls
Texas
University of Texas, MD Anderson Cancer Center
RECRUITING
Houston
Other Locations
Japan
Aichi Cancer Center
RECRUITING
Aichi
Hiroshima University Hospital
RECRUITING
Hiroshima
Kyoto Prefectural University of Medicine
RECRUITING
Kyoto
Tokyo Medical University Hospital
RECRUITING
Tokyo
Tottori University Hospital
RECRUITING
Yonago
Taiwan
Kaohsiung Medical University Chung-Ho Memorial Hospital
ASP-1929 320 mg/m\^2 IV infusion followed by illumination with 690 nm red light at accessible tumor sites using the investigational PIT690 Laser System (24 ± 4 hours after end of ASP-1929 infusion). Treatment with ASP-1929 PIT will be repeated every 4 to 6 weeks depending on clinical judgement of investigators.~Pembrolizumab: 200 mg every 3 weeks (Q3W) IV infusion over 30 minutes for the first 6 cycles. After the first 6 cycles, pembrolizumab dosing regimen can be converted from 200 mg Q3W to 400 mg every 6 weeks (Q6W) at the investigator's discretion.~Treatment in the experimental arm will start with the infusion of pembrolizumab on Cycle 1 Day 1 (C1D1) after which ASP-1929 Photoimmunotherapy will follow 7 days later, on Treatment 1 Day 1 (T1D1). Patients will be treated with ASP-1929 PIT and pembrolizumab for up to 24 months.
ASP-1929 640 mg/m\^2 IV infusion followed by illumination with 690 nm red light at accessible tumor sites using the investigational PIT690 Laser System (24 ± 4 hours after end of ASP-1929 infusion). Treatment with ASP-1929 PIT will be repeated every 4 to 6 weeks depending on clinical judgement of investigators.~Pembrolizumab: 200 mg every 3 weeks (Q3W) IV infusion over 30 minutes for the first 6 cycles. After the first 6 cycles, pembrolizumab dosing regimen can be converted from 200 mg Q3W to 400 mg every 6 weeks (Q6W) at the investigator's discretion.~Treatment in the experimental arm will start with the infusion of pembrolizumab on Cycle 1 Day 1 (C1D1) after which ASP-1929 Photoimmunotherapy will follow 7 days later, on Treatment 1 Day 1 (T1D1). Patients will be treated with ASP-1929 PIT and pembrolizumab for up to 24 months.
Active_comparator: Pembrolizumab or pembrolizumab + chemotherapy (Control)
Patients in the control arm will receive physician's choice SOC. Patients randomized to SOC may only be treated with one of the following SOC options:~1. Pembrolizumab alone~2. Pembrolizumab + platinum (cisplatin or carboplatin) + 5-fluorouracil (5-FU) or taxane (paclitaxel or docetaxel)~Pembrolizumab: 200 mg Q3W IV infusion over 30 minutes for the first 6 cycles. After the first 6 cycles, pembrolizumab administration can be switched from 200 mg Q3W to 400 mg Q6W at the investigator's discretion.~Cisplatin or carboplatin: AUC 5 mg/mL/min or 100 mg/m\^2 IV infusion on Day 1 of each cycle, Q3W for up to 6 cycles~5-FU: 1000 mg/m\^2 IV infusion per day from Days 1-4 of each cycle, Q3W for up to 6 cycles~Paclitaxel: At investigator's choice, 100 mg/m\^2 IV infusion on Day 1 and Day 8 of each 21-day cycle or paclitaxel 175 mg/m\^2 IV infusion on Day 1 of each 21-day cycle for up to 6 cycles~Docetaxel: 75 mg/m\^2 IV infusion on Day 1 of each cycle, Q3W for up to 6 cycles
Who is this study for: Patients with unresectable recurrent, or metastatic head and neck squamous cell carcinoma which is positive for human papilloma virus 16 and expresses PD-L1