Clinical Trials Directory

Trials / Completed

CompletedNCT02921269

Atezolizumab and Bevacizumab in Treating Patients With Recurrent, Persistent, or Metastatic Cervical Cancer

A Phase 2 Study of Atezolizumab (MPDL3280A) in Combination With Bevacizumab in Patients With Recurrent, Persistent or Metastatic Cervical Cancer

Status
Completed
Phase
Phase 2
Study type
Interventional
Enrollment
11 (actual)
Sponsor
National Cancer Institute (NCI) · NIH
Sex
Female
Age
18 Years
Healthy volunteers
Not accepted

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.

Conditions

Interventions

TypeNameDescription
DRUGAtezolizumabGiven IV
BIOLOGICALBevacizumabGiven IV
OTHERLaboratory Biomarker AnalysisCorrelative studies

Timeline

Start date
2017-03-10
Primary completion
2020-10-01
Completion
2021-01-13
First posted
2016-10-03
Last updated
2023-02-21
Results posted
2023-02-21

Locations

22 sites across 1 country: United States

Regulatory

Source: ClinicalTrials.gov record NCT02921269. Inclusion in this directory is not an endorsement.