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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
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.
Minimum Age: 2 Years
Eligible Ages: CHILD, ADULT, OLDER_ADULT
Sex: ALL
Healthy Volunteers: No
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
Name: Alice P Chen
Affiliation: National Cancer Institute LAO
Role: PRINCIPAL_INVESTIGATOR