Ignite Creation Date:
2025-12-24 @ 11:52 AM
Ignite Modification Date:
2026-01-08 @ 7:03 PM
Study NCT ID:
NCT03818061
Status:
UNKNOWN
Last Update Posted:
2023-09-28
First Post:
2019-01-21
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Atezolizumab and Bevacizumab in Patients With Recurrent or Metastatic Squamous-cell Carcinoma of the Head and Neck
Sponsor:
Centre Leon Berard
Organization:
Study Overview
Official Title:
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
Status Verified Date:
2023-09
Last Known Status:
ACTIVE_NOT_RECRUITING
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
ATHENA
Brief 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.
* 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.
Study Oversight
Has Oversight DMC:
True
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: