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ASP-1929 Photoimmunotherapy Combined With Pembrolizumab in Patients With Recurrent Head and Neck Cancer, With or Without Metastases

Head and Neck Cancer Clinical Trial

Official title:
A Phase 2 Single-arm Study of ASP-1929 Photoimmunotherapy Combined With Pembrolizumab in Patients With Locoregional Recurrent Squamous Cell Carcinoma of the Head and Neck, With or Without Metastases, Not Amenable to Curative Local Treatment

Clinical Trial Summary

A Phase 2 Single-arm Study of ASP-1929 Photoimmunotherapy Combined With Pembrolizumab in Patients With Locoregional Recurrent Squamous Cell Carcinoma of the Head and Neck, With or Without Metastases, Not Amenable to Curative Local Treatment

Clinical Trial Description

A Single-arm Study of ASP-1929 Photoimmunotherapy Combined With Pembrolizumab. Patients will receive the approved label dose of pembrolizumab, which is administered every 3 weeks on days 1 and 22 of each treatment cycle. On Day 8 of each cycle, patients will receive ASP-1929 followed by illumination at accessible tumor sites using the investigational PIT690 Laser System on Day 9. Each treatment cycle, which is driven by ASP-1929 PIT frequency of administration, will last 42 days. Patients will be treated with ASP-1929 PIT and pembrolizumab for up to 12 months with a maximum of 8 treatment cycles. ;

Study Design

Related Conditions & MeSH terms

Clinical Trial Details
NCT number NCT05265013
Study type Interventional
Source Rakuten Medical, Inc.
Contact
Status Terminated
Phase Phase 2
Start date April 19, 2022
Completion date March 29, 2024
View Details
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