NCT06762808

Phase II Study of Atezolizumab and Tiragolumab With ctDNA for HPV-positive SCC

Phase II Trial of Atezolizumab and Tiragolumab for Patients With Detectable Circulating Tumor DNA After Definitive Treatment for HPV-positive Squamous Cell Carcinoma

• Status: Withdrawn
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 0 (actual)
• Sponsor: M.D. Anderson Cancer Center · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

A single-arm, phase II study for patients with detectable HPV CtDNA at 12 weeks or longer after completion of definitive therapy for non-metastatic, HPV+ squamous cell carcinoma.

Detailed description

Primary Objective: To estimate the 1-year disease-free survival (DFS) for patients treated with atezolizumab plus tiragolumab for detectable HPV ctDNA following definitive therapy for HPV+ squamous cell carcinoma. Secondary Objectives: To describe local recurrence at 1 year for patients treated with atezolizumab plus tiragolumab for detectable HPV ctDNA after following definitive therapy for HPV+ squamous cell carcinoma. To describe rate of distant metastatic disease occurrence for patients treated with atezolizumab plus tiragolumab for detectable HPV ctDNA after following definitive therapy for HPV+ squamous cell carcinoma. To estimate 1-year overall survival for patients treated with atezolizumab plus tiragolumab for detectable HPV ctDNA after following definitve therapy for HPV+ squamous cell carcinoma. To summarize safety and toxicity (CTCAE v5) for patients treated with atezolizumab plus tiragolumab for detectable HPV ctDNA ater following definitve therapy for HPV+ squamous cell carcinoma. To determine HPV ctDNA clearance rates for patients treated with atezolizumab plus tiragolumab for detectable HPV ctDNA after following definitive therapy for HPV+ squamous cell carcinoma.

Conditions

• Squamous Cell Carcinoma

Interventions

Type	Name	Description
DRUG	Atezolizumab	Given by IV infusion
DRUG	Talazoparib	Given by IV infusion

Timeline

• Start date: 2025-05-01
• Primary completion: 2025-08-08
• Completion: 2025-08-08
• First posted: 2025-01-08
• Last updated: 2025-08-15

Regulatory

• FDA-regulated drug study