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

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

• Status: Recruiting
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 412 (estimated)
• Sponsor: Rakuten Medical, Inc. · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

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.

Detailed description

This is a phase 3 multicenter, randomized study designed to evaluate the efficacy and safety of ASP-1929 photoimmunotherapy (PIT) in combination with pembrolizumab versus pembrolizumab-based standard of care (SOC) as first-line treatment of locoregional recurrent HNSCC in patients with no distant metastases. Patients will be enrolled into the study starting with 3 treatment arms, ASP-1929 PIT at doses of 320 mg/m\^2 or 640 mg/m\^2 in combination with pembrolizumab treatment arms or a SOC treatment arm in which patients may receive pembrolizumab alone or pembrolizumab plus chemotherapy according to physician's choice. Treatment assignment within the SOC treatment arm will be based on the decision of the site investigator. To ensure that the SOC treatment arm is appropriately balanced, a 50% enrollment cap will be imposed on pembrolizumab monotherapy and pembrolizumab plus chemotherapy, so that approximately the same number of patients will have been treated within each category. At the start of the study all patients will be randomized 2:2:1 ratio to ASP-1929 PIT 320 mg/m\^2 plus pembrolizumab versus ASP-1929 PIT 640 mg/m\^2 plus pembrolizumab versus SOC (pembrolizumab alone or pembrolizumab plus chemotherapy according to physician's choice). An interim analysis (IA) will be conducted for this study as part of the dose optimization process. Patient enrollment will continue during the period of preparation and conduct of this IA. Based on the findings from the first interim analysis (IA1), the Sponsor will have the option to close one of the two ASP-1929 PIT treatment arms for enrollment. The final decision on the optimized ASP-1929 PIT dose for this study will be made in agreement with the US Food and Drug Administration (FDA).

Conditions

• Recurrent Head and Neck Squamous Cell Carcinoma

Interventions

Type	Name	Description
COMBINATION_PRODUCT	ASP-1929 Photoimmunotherapy	ASP-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)
BIOLOGICAL	Pembrolizumab	200 mg Q3W or 400 mg Q6W, IV infusion over 30 minutes (up to 24 months)
DRUG	Carboplatin	Area under the curve (AUC) 5 mg/mL/min IV infusion, Q3W up to 6 cycles
DRUG	Cisplatin	100 mg/m\^2 IV infusion, Q3W up to 6 cycles
DRUG	5-fluorouracil	1000 mg/m\^2 per day from Days 1-4 of each cycle, IV infusion, Q3W up to 6 cycles
DRUG	Paclitaxel	100 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
DRUG	Docetaxel	75 mg/m\^2 IV Infusion, Q3W up to 6 cycles

Timeline

• Start date: 2024-12-24
• Primary completion: 2028-09-01
• Completion: 2028-09-01
• First posted: 2024-11-21
• Last updated: 2025-10-15

Locations

22 sites across 3 countries: United States, Japan, Taiwan

Regulatory

• FDA-regulated drug study
• FDA-regulated device study