NCT04710498

Neoadjuvant Atezolizumab in Surgically Resectable Advanced Cutaneous Squamous Cell Carcinoma

ML42362: Neoadjuvant Atezolizumab in Surgically Resectable Advanced Cutaneous Squamous Cell Carcinoma

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 20 (actual)
• Sponsor: Stanford University · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

The purpose of this research is to evaluate whether the administration of atezolizumab before surgical resection of the tumor is feasible and to evaluate the treatment response, safety, and tolerability of atezolizumab.

Detailed description

Primary Objective: Determine the feasibility of three doses of atezolizumab prior to surgery in patients with advanced cutaneous squamous cell carcinoma Secondary Objectives: * Assess response rates to neoadjuvant atezolizumab * Objective response rate following completion of neoadjuvant therapy based on RECIST 1.1 criteria * Pathological response rate (major and complete pathological response) in final surgical resection specimen * Assess change in surgical margins or vital structures preserved following neoadjuvant treatment * Assess safety and tolerability of neoadjuvant atezolizumab

Conditions

• Cutaneous Squamous Cell Carcinoma

Interventions

Type	Name	Description
DRUG	Atezolizumab	Atezolizumab administered intravenous (IV) infusion at a fixed dose of 1200 mg

Timeline

• Start date: 2021-06-22
• Primary completion: 2024-02-07
• Completion: 2024-02-15
• First posted: 2021-01-14
• Last updated: 2025-02-03
• Results posted: 2025-02-03

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated drug study