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Brief Title: Testing Atezolizumab in People 2-17 Years Old With Clear Cell Sarcoma or Advanced Chondrosarcoma
Official Title: A Phase 2 Study of Anti-PD-L1 Antibody (Atezolizumab) in Chondrosarcoma and Clear Cell Sarcoma
Study ID: NCT04458922
Brief Summary: This phase II trial studies how well atezolizumab works in treating patients with chondrosarcoma or clear cell sarcoma that is newly diagnosed, cannot be removed by surgery (unresectable), or has spread to other places in the body (metastatic). Immunotherapy with monoclonal antibodies, such as atezolizumab, may help the body's immune system attack the cancer, and may interfere with the ability of tumor cells to grow and spread.
Detailed Description: PRIMARY OBJECTIVE: I. Determine the objective response rates (ORR) using Response Evaluation Criteria in Solid Tumors (RECIST) version (v) 1.1 of atezolizumab in adult (\>= 18 years) patients with clear cell sarcoma (CCS) and chondrosarcoma (CS). SECONDARY OBJECTIVES: I. Determine duration of response (DOR) using RECIST v 1.1 and/or change in clinical symptoms (time frame: baseline until disease progression, death, loss to follow-up, initiation of another anti-cancer treatment, withdrawal of consent, or study termination). II. Measure progression-free survival (PFS) time (time frame: baseline until disease progression, death, loss to follow-up, initiation of another anti-cancer treatment, withdrawal of consent, or study termination). III. Assess the number of activated CD8+ T cells infiltrating the tumor before and after atezolizumab treatment, and correlate treatment-induced changes with clinical response. EXPLORATORY OBJECTIVES: I. Compare RECIST v 1.1 versus (vs) immune RECIST (iRECIST) in patients with CCS and CS on atezolizumab. II. Examine changes in PD-1/PD-L1 expression in the tumor microenvironment before and after atezolizumab treatment, and correlate treatment-induced changes with clinical response. III. Evaluate potential associations between atezolizumab activity and tumor genomic alterations. OUTLINE: Patients receive atezolizumab intravenously (IV) over 30-60 minutes on day 1. Cycles repeat every 21 days in the absence of disease progression or unacceptable toxicity. Patients undergo computed tomography (CT) scans and undergo biopsy and collection of blood samples on study. After completion of study treatment, patients are followed up to 90 days.
Minimum Age: 2 Years
Eligible Ages: CHILD, ADULT, OLDER_ADULT
Sex: ALL
Healthy Volunteers: No
USC / Norris Comprehensive Cancer Center, Los Angeles, California, United States
University of Florida Health Science Center - Gainesville, Gainesville, Florida, United States
Emory University Hospital Midtown, Atlanta, Georgia, United States
Emory University Hospital/Winship Cancer Institute, Atlanta, Georgia, United States
National Cancer Institute Developmental Therapeutics Clinic, Bethesda, Maryland, United States
National Institutes of Health Clinical Center, Bethesda, Maryland, United States
NCI - Center for Cancer Research, Bethesda, Maryland, United States
Dana-Farber Cancer Institute, Boston, Massachusetts, United States
Washington University School of Medicine, Saint Louis, Missouri, United States
Siteman Cancer Center-South County, Saint Louis, Missouri, United States
Ohio State University Comprehensive Cancer Center, Columbus, Ohio, United States
University of Pittsburgh Cancer Institute (UPCI), Pittsburgh, Pennsylvania, United States
Vanderbilt University/Ingram Cancer Center, Nashville, Tennessee, United States
M D Anderson Cancer Center, Houston, Texas, United States
University Health Network-Princess Margaret Hospital, Toronto, Ontario, Canada
Name: A P Chen
Affiliation: National Cancer Institute LAO
Role: PRINCIPAL_INVESTIGATOR