NCT03818061

Atezolizumab and Bevacizumab in Patients With Recurrent or Metastatic Squamous-cell Carcinoma of the Head and Neck

A European, Multi-centre Phase II Trial of Atezolizumab and Bevacizumab in Patients With Recurrent or Metastatic Squamous-cell Carcinoma of the Head and Neck (HNSCC)

• Status: Unknown
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 33 (actual)
• Sponsor: Centre Leon Berard · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

This proof-of-concept study aims to assess the clinical and biological effects of Atezolizumab combined with Bevacizumab in advanced previously treated squamous-cell carcinoma of the head and neck (HNSCC).

Detailed description

Patients will receive the combination of Atezolizumab 1200 mg and Bevacizumab 15 mg/kg by IV infusion every 3 weeks. Treatment will be continued until disease progression, unacceptable toxicity or voluntary withdrawal. In the absence of unacceptable toxicity, patients who meet criteria for disease progression per RECIST v1.1 while receiving study treatment will be permitted to continue the study treatment if they meet all of the following criteria: * Evidence of clinical benefit, as determined by the investigator following a review of all available data * Absence of symptoms and signs (including laboratory values, such as new or worsening hypercalcemia) indicating unequivocal progression of disease * Absence of decline in ECOG Performance Status that can be attributed to disease progression * Absence of tumor progression at critical anatomical sites (e.g., leptomeningeal disease) that cannot be managed by protocol-allowed medical interventions.

Conditions

• Head and Neck Neoplasms

Interventions

Type	Name	Description
DRUG	Atezolizumab	Patients will receive the combination of Atezolizumab 1200 mg and Bevacizumab 15 mg/kg by IV infusion every 3 weeks.
DRUG	Bevacizumab	Patients will receive the combination of Atezolizumab 1200 mg and Bevacizumab 15 mg/kg by IV infusion every 3 weeks.

Timeline

• Start date: 2019-03-26
• Primary completion: 2024-03-01
• Completion: 2024-03-01
• First posted: 2019-01-28
• Last updated: 2023-09-28

Locations

7 sites across 1 country: France