Georgia's Online Cancer Information Center

Find A Clinical Trial

A Phase 2 Study of Anti-PD-L1 Antibody (Atezolizumab) in Alveolar Soft Part Sarcoma

Status
Active
Cancer Type
Bone and Soft Tissue (including Sarcoma)
Trial Phase
Phase II
Eligibility
6 and over, Male and Female
Study Type
Treatment
NCD ID
NCT03141684
Protocol IDs
10005 (primary)
NCI-2016-01040
17-C-007
CC 17-C-0074
17-C-0074
Study Sponsor
National Cancer Institute

Summary

This phase II trial studies how well atezolizumab works in treating patients with alveolar soft part sarcoma that has not been treated, has spread from where it started to other places in the body and cannot be removed by surgery. Monoclonal antibodies, such as atezolizumab, may allow the immune system cells to find and kill the tumor cells.

Objectives

PRIMARY OBJECTIVES:

I. Determine the objective response rate (ORR) using Response Evaluation Criteria in Solid Tumors (RECIST) version (v) 1.1 of atezolizumab in patients with advanced alveolar soft part sarcoma (ASPS) in adult subjects >= 18 years and in pediatric/adolescent subjects >= 6 years.

SECONDARY OBJECTIVES:

I. Determine duration of response (DOR) using RECIST v 1.1 and/or change in clinical symptoms.

II. Measure progression-free survival (PFS) time as determined by investigator using RECIST v 1.1.

III. At the Clinical Center, National Cancer Institute (NCI), only: correlate response with expression of potential immune biomarkers in paired biopsies.

IV. Compare the RECIST v 1.1 versus (vs) the immune-related response criteria (irRC) in patients with ASPS on atezolizumab.

OUTLINE:

Patients receive atezolizumab intravenously (IV) over 30-60 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 for 4 weeks.

Treatment Sites in Georgia

Emory University Hospital - Midtown


550 Peachtree Street NE
Atlanta, GA 30308
404-686-4411
www.emoryhealthcare.org

Georgia CORE

 

Hearts and Minds Dedicated to Improving Cancer Care

Georgia CORE is a public-private partnership that creates collaboration among the state’s cancer organizations and institutions to connect more Georgians to quality, personalized cancer care. We welcome you to this one-of-a-kind online information center for all things related to cancer and survivorship care in Georgia.