Ignite Creation Date:
2025-12-24 @ 11:10 PM
Ignite Modification Date:
2026-02-12 @ 3:40 AM
Study NCT ID:
NCT02921269
Status:
COMPLETED
Last Update Posted:
2023-02-21
First Post:
2016-09-30
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Atezolizumab and Bevacizumab in Treating Patients With Recurrent, Persistent, or Metastatic Cervical Cancer
Sponsor:
National Cancer Institute (NCI)
Organization:
Study Overview
Official Title:
A Phase 2 Study of Atezolizumab (MPDL3280A) in Combination With Bevacizumab in Patients With Recurrent, Persistent or Metastatic Cervical Cancer
Status:
COMPLETED
Status Verified Date:
2023-01
Last Known Status:
None
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:
None
Brief Summary:
This phase II trial studies how well atezolizumab and bevacizumab work in treating patients with cervical cancer that has come back, remains despite treatment, or has spread to other places in the body. Monoclonal antibodies, such as atezolizumab and bevacizumab, may shrink tumor cell and interfere with the ability of tumor cells to grow and spread.
Detailed Description:
PRIMARY OBJECTIVES:
I. To assess the anti-tumor activity (proportion of patients with objective response by Response Evaluation Criteria in Solid Tumors version 1.1 \[RECIST 1.1\] criteria) of atezolizumab and bevacizumab in patients with recurrent, persistent or metastatic cervical cancer.
SECONDARY OBJECTIVES:
I. To estimate the duration of progression free survival (PFS) and overall survival (OS).
II. To assess safety by Common Terminology Criteria for Adverse Events version 5.0 (CTCAE v.5.0).
III. To describe the efficacy of the combination of atezolizumab and bevacizumab as measured by objective response, by PD-L1 expression on tumor and immune cells measured by semi-quantitative immunohistochemistry (IHC).
IV. To describe the efficacy of the combination of atezolizumab and bevacizumab as measured by objective response, by intratumoral and peripheral T-cell receptor (TCR) clonality and tumor infiltrating lymphocyte proportion.
OUTLINE:
Patients receive atezolizumab intravenously (IV) over 30-60 minutes and bevacizumab IV over 30-90 minutes on day 1. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity.
After completion of study treatment, patients are followed up every 3 months for 2 years.
I. To assess the anti-tumor activity (proportion of patients with objective response by Response Evaluation Criteria in Solid Tumors version 1.1 \[RECIST 1.1\] criteria) of atezolizumab and bevacizumab in patients with recurrent, persistent or metastatic cervical cancer.
SECONDARY OBJECTIVES:
I. To estimate the duration of progression free survival (PFS) and overall survival (OS).
II. To assess safety by Common Terminology Criteria for Adverse Events version 5.0 (CTCAE v.5.0).
III. To describe the efficacy of the combination of atezolizumab and bevacizumab as measured by objective response, by PD-L1 expression on tumor and immune cells measured by semi-quantitative immunohistochemistry (IHC).
IV. To describe the efficacy of the combination of atezolizumab and bevacizumab as measured by objective response, by intratumoral and peripheral T-cell receptor (TCR) clonality and tumor infiltrating lymphocyte proportion.
OUTLINE:
Patients receive atezolizumab intravenously (IV) over 30-60 minutes and bevacizumab IV over 30-90 minutes on day 1. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity.
After completion of study treatment, patients are followed up every 3 months for 2 years.
Study Oversight
Has Oversight DMC:
False
Is a FDA Regulated Drug?:
True
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?: