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Spots Global Cancer Trial Database for Testing Atezolizumab Alone or Atezolizumab Plus Bevacizumab in People With Advanced Alveolar Soft Part Sarcoma

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Trial Identification

Brief Title: Testing Atezolizumab Alone or Atezolizumab Plus Bevacizumab in People With Advanced Alveolar Soft Part Sarcoma

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

Study ID: NCT03141684

Study Description

Brief Summary: This phase II trial studies how well atezolizumab or atezolizumab plus bevacizumab 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 (advanced) and cannot be removed by surgery (unresectable). Atezolizumab works by unblocking the immune system, allowing the immune system cells to recognize and then attack tumor cells. Bevacizumab works by controlling the growth of new blood vessels. Giving atezolizumab alone or atezolizumab with bevacizumab may shrink the cancer.

Detailed Description: 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 \>= 2 years. II. Determine the ORR using RECIST v 1.1 of atezolizumab and bevacizumab in subjects \>= 18 years old with advanced ASPS that has progressed on atezolizumab monotherapy. SECONDARY OBJECTIVES: I. Determine duration of response (DOR) to atezolizumab monotherapy or atezolizumab plus bevacizumab using RECIST v 1.1 and/or change in clinical symptoms. II. Measure progression-free survival (PFS) time for patients receiving atezolizumab monotherapy or atezolizumab plus bevacizumab as determined by investigator using RECIST v 1.1. III. Assess the number of activated CD8+ T cells infiltrating the tumor before and after treatment with atezolizumab monotherapy or atezolizumab plus bevacizumab, and correlate treatment-induced changes with clinical response. IV. Measure and describe the atezolizumab pharmacokinetics (PK) and anti-drug antibodies (ADA) in patients ages 2-11 years old. EXPLORATORY OBJECTIVES: I. Compare RECIST v 1.1 vs immune RECIST (iRECIST) in patients with ASPS on atezolizumab and atezolizumab + bevacizumab. II. Assess the post-progression response rate among patients who progress while on treatment holiday and then resume treatment. III. Analyze the genomic and immune profiles of tumors expressing type 1 or type 2 ASPL-TFE3 fusions and correlate findings with response to atezolizumab or atezolizumab in combination with bevacizumab. IV. Measure and describe the atezolizumab pharmacokinetics (PK) in patients \>= 12 years old. OUTLINE: Patients are assigned to 1 of 2 arms. ARM I: 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 in arm I who do achieve disease progression may cross-over to arm II. Patients also undergo computed tomography (CT) imaging, and collection of blood and urine at baseline. ARM II: Patients receive atezolizumab IV over 30-60 minutes and bevacizumab IV over 30-90 minutes on day 1. Cycles repeat every 21 days in the absence of disease progression or unacceptable toxicity. Patients also undergo CT imaging, and collection of blood and urine at baseline. After completion of study treatment, patients are followed up for 27-30 days. Patients who are progression-free at the end of a 2-year treatment holiday are followed every 6 months.

Keywords

Eligibility

Minimum Age: 2 Years

Eligible Ages: CHILD, ADULT, OLDER_ADULT

Sex: ALL

Healthy Volunteers: No

Locations

Mayo Clinic Hospital in Arizona, Phoenix, Arizona, United States

Mayo Clinic in Arizona, Scottsdale, Arizona, United States

Keck Medicine of USC Buena Park, Buena Park, California, United States

Keck Medicine of USC Koreatown, Los Angeles, California, United States

Los Angeles General Medical Center, Los Angeles, California, United States

USC / Norris Comprehensive Cancer Center, Los Angeles, California, United States

USC Norris Oncology/Hematology-Newport Beach, Newport Beach, California, United States

Keck Medical Center of USC Pasadena, Pasadena, California, United States

University of California Davis Comprehensive Cancer Center, Sacramento, California, United States

Smilow Cancer Hospital-Derby Care Center, Derby, Connecticut, United States

Smilow Cancer Hospital Care Center-Fairfield, Fairfield, Connecticut, United States

Smilow Cancer Hospital Care Center - Guilford, Guilford, Connecticut, United States

Smilow Cancer Hospital Care Center at Saint Francis, Hartford, Connecticut, United States

Smilow Cancer Center/Yale-New Haven Hospital, New Haven, Connecticut, United States

Yale University, New Haven, Connecticut, United States

Yale-New Haven Hospital North Haven Medical Center, North Haven, Connecticut, United States

Smilow Cancer Hospital-Orange Care Center, Orange, Connecticut, United States

Smilow Cancer Hospital-Torrington Care Center, Torrington, Connecticut, United States

Smilow Cancer Hospital Care Center-Trumbull, Trumbull, Connecticut, United States

Smilow Cancer Hospital-Waterbury Care Center, Waterbury, Connecticut, United States

Smilow Cancer Hospital Care Center - Waterford, Waterford, Connecticut, United States

Mayo Clinic in Florida, Jacksonville, Florida, United States

Emory University Hospital Midtown, Atlanta, Georgia, United States

University of Iowa/Holden Comprehensive Cancer Center, Iowa City, Iowa, United States

Johns Hopkins University/Sidney Kimmel Cancer Center, Baltimore, Maryland, 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

Massachusetts General Hospital Cancer Center, Boston, Massachusetts, United States

Brigham and Women's Hospital, Boston, Massachusetts, United States

Beth Israel Deaconess Medical Center, Boston, Massachusetts, United States

Dana-Farber Cancer Institute, Boston, Massachusetts, United States

Mayo Clinic in Rochester, Rochester, Minnesota, United States

Siteman Cancer Center at West County Hospital, Creve Coeur, Missouri, United States

Washington University School of Medicine, Saint Louis, Missouri, United States

Siteman Cancer Center-South County, Saint Louis, Missouri, United States

Children's Hospital and Medical Center of Omaha, Omaha, Nebraska, United States

University of Nebraska Medical Center, Omaha, Nebraska, United States

NYP/Columbia University Medical Center/Herbert Irving Comprehensive Cancer Center, New York, New York, United States

Duke University Medical Center, Durham, North Carolina, United States

Ohio State University Comprehensive Cancer Center, Columbus, Ohio, United States

University of Pittsburgh Cancer Institute (UPCI), Pittsburgh, Pennsylvania, United States

Vanderbilt Breast Center at One Hundred Oaks, Nashville, Tennessee, United States

Vanderbilt University/Ingram Cancer Center, Nashville, Tennessee, United States

M D Anderson Cancer Center, Houston, Texas, United States

Contact Details

Name: Alice P Chen

Affiliation: National Cancer Institute LAO

Role: PRINCIPAL_INVESTIGATOR

Useful links and downloads for this trial

Clinicaltrials.gov

Google Search Results

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