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Spots Global Cancer Trial Database for Testing Atezolizumab in People 2-17 Years Old With Clear Cell Sarcoma or Advanced Chondrosarcoma

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Trial Identification

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

Study Description

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.

Keywords

Eligibility

Minimum Age: 2 Years

Eligible Ages: CHILD, ADULT, OLDER_ADULT

Sex: ALL

Healthy Volunteers: No

Locations

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

Contact Details

Name: A P Chen

Affiliation: National Cancer Institute LAO

Role: PRINCIPAL_INVESTIGATOR

Useful links and downloads for this trial

Clinicaltrials.gov

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