Testing Atezolizumab Alone or Atezolizumab Plus Bevacizumab in People With Advanced Alveolar Soft Part Sarcoma
A Phase 2 Study of Anti-PD-L1 Antibody (Atezolizumab) in Alveolar Soft Part Sarcoma
5 other identifiers
interventional
63
1 country
42
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for phase_2
Started Apr 2017
Longer than P75 for phase_2
42 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
April 25, 2017
CompletedFirst Submitted
Initial submission to the registry
May 3, 2017
CompletedFirst Posted
Study publicly available on registry
May 5, 2017
CompletedPrimary Completion
Last participant's last visit for primary outcome
October 31, 2026
ExpectedStudy Completion
Last participant's last visit for all outcomes
October 31, 2026
April 13, 2026
April 1, 2026
9.5 years
May 3, 2017
April 9, 2026
Conditions
Outcome Measures
Primary Outcomes (1)
Objective response rate
Will be evaluated using Response Evaluation Criteria in Solid Tumors version 1.1. If at least 3 responses (at least 12.5%) are observed among the 24 evaluable patients, this regimen would be considered worthy of further testing in this disease.
Up to 4 weeks after the last dose of study treatment
Secondary Outcomes (5)
Duration of response
Baseline until disease progression, death, loss to follow-up, initiation of another anti-cancer treatment, withdrawal of consent, or study, assessed up to 4 weeks after the last dose of study treatment
Progression free survival
Baseline until disease progression, death, loss to follow-up, initiation of another anti-cancer treatment, withdrawal of consent, or study, assessed up to 4 weeks after the last dose of study treatment
Immune biomarkers in paired biopsies
Up to 4 weeks after the last dose of study treatment
Immune-related response
Up to 4 weeks after the last dose of study treatment
Pediatric pharmacokinetics and anti-drug antibodies
Up to 5 years
Study Arms (2)
Arm I (atezolizumab)
EXPERIMENTALPatients receive atezolizumab IV over 30-60 minutes on day 1 of each cycle. 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. (CLOSED TO ACCRUAL)
Arm II (atezolizumab, bevacizumab)
EXPERIMENTALPatients receive atezolizumab IV over 30-60 minutes and bevacizumab IV over 30-90 minutes on day 1 of each cycle. 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.
Interventions
Given IV
Given IV
Undergo collection of blood and urine
Undergo CT
Eligibility Criteria
You may qualify if:
- Patients must have histologically or cytologically confirmed alveolar soft part sarcoma that is not curable by surgery. Diagnosis of malignancy must be confirmed by the department of pathology at the institution where the patient is enrolled prior to patient enrollment. To be eligible for atezolizumab in combination with bevacizumab, the patient must have atezolizumab-refractory/resistant disease that has progressed (definitive clinical progression or confirmed progressive disease \[iCPD\]) on prior 10005 atezolizumab monotherapy
- Patients must have measurable disease, defined as at least one lesion that can be accurately measured in at least one dimension (longest diameter to be recorded for non-nodal lesions and short axis for nodal lesions) as \>= 20 mm (\>= 2 cm) by chest x-ray or as \>= 10 mm (\>= 1 cm) with computed tomography (CT) scan, magnetic resonance imaging (MRI), or calipers by clinical exam
- Note: Once the primary endpoint of the trial has been met, pediatric patients may enroll with evaluable non-measurable disease and will not be required to have measurable disease. Evaluable non-measurable disease is that which is not measurable by RECIST1.1 but can be evaluated by imaging (e.g., CT, bone scan, or ultrasound) or other methods
- Patients with newly diagnosed, unresectable, metastatic and measurable ASPS will also be eligible for atezolizumab monotherapy if they show clinical evidence of disease progression (including history and increasing physical symptoms); on-study documentation will include a physician's rationale that supports evidence of clinical disease progression (i.e., increasing tumor pain)
- To be eligible for atezolizumab monotherapy, subjects must be \>= 2 years of age. To be eligible for atezolizumab in combination with bevacizumab, subjects must be \>= 18 years of age
- Eastern Cooperative Oncology Group (ECOG) performance status =\< 2 (Karnofsky or Lansky \>= 70%)
- Life expectancy of greater than 3 months
- Absolute neutrophil count \>= 1,500/mcL
- Platelets \>= 100,000/mcL
- Hemoglobin \>= 8 g/dL
- Total bilirubin =\< 1.5 x institutional upper limit of normal (ULN) (however, patients with known Gilbert disease who have serum bilirubin level =\< 3 x ULN may be enrolled)
- Aspartate aminotransferase (AST) (serum glutamic oxaloacetic transaminase \[SGOT\])/alanine aminotransferase (ALT) (serum glutamic pyruvic transaminase \[SGPT\]) =\< 3 x ULN (AST and/or ALT =\< 5 x ULN for patients with liver involvement)
- Alkaline phosphatase =\< 2.5 x ULN (=\< 5 x ULN for patients with documented liver involvement or bone metastases)
- Creatinine clearance for adult patients (\>= 18 years of age): \>= 30 mL/min/1.73 m\^2 by Cockcroft-Gault; for pediatric patients (\< 18 years of age), a serum creatinine based on age and sex as follows:
- Age 2 to \< 6 years, maximum serum creatinine (mg/dL) male 0.8, female 0.8;
- +10 more criteria
You may not qualify if:
- Any prior therapy must have been completed \>= 4 weeks or, if known, \>= 5 half-lives of the prior agent (whichever is shorter) prior to enrollment on protocol (minimum of 1 week between prior therapy and study enrollment), and the participant must have recovered to eligibility levels from prior toxicity. Note: For patients being treated on the atezolizumab plus bevacizumab arm, there is no washout requirement for prior anti-PD-1 or anti-PD-L1 agents.
- Patients should be at least 6 weeks out from nitrosoureas and mitomycin C. Prior definitive radiation should have been completed \>= 4 weeks or palliative radiation should have been completed \>= 2 weeks prior to study enrollment or crossover and all associated toxicities resolved to eligibility levels (patients on study may be eligible for palliative radiotherapy to non-targeted lesions after 2 cycles of therapy at the principal investigator \[PI\]'s discretion). Patients who have had prior monoclonal antibody therapy must have completed that therapy \>= 6 weeks (or 3 half-lives of the antibody, whichever is shorter) prior to enrollment on protocol (minimum of 1 week between prior therapy and study enrollment). A patient who has received a cumulative dose of \> 350 mg/m\^2 of anthracycline (regardless of cardioprotectant) may only be enrolled if their ejection fraction measured by an echocardiogram is within normal institutional limits
- Prior treatment with anti-PD-1 or anti-PD-L1 therapeutic antibody, or pathway-targeting agents
- Patients who have received prior treatment with anti-CTLA-4 may be enrolled on the atezolizumab monotherapy arm, provided the following requirements and all other selection criteria are met:
- Minimum of 12 weeks from the first dose of anti-CTLA-4 and \> 6 weeks from the last dose
- No history of severe immune-related adverse effects from anti-CTLA-4 (NCI Common Terminology Criteria for Adverse Events \[CTCAE\] grade 3 and 4)
- Patients who have progressed on P10005 atezolizumab monotherapy may be eligible for the atezolizumab plus bevacizumab arm, provided the following requirements, and all other selection criteria, are met:
- No prior disease progression on an immune checkpoint inhibitor plus tyrosine kinase inhibitor combination therapy
- Any prior toxicities have resolved to eligibility levels
- No contraindications
- Treatment with any other investigational agent within 4 weeks (or within five half-lives of the investigational product, whichever is shorter) prior to cycle 1, day 1 (minimum of 1 week between prior therapy and study enrollment); patients must be \>= 2 weeks since any investigational agent administered as part of a phase 0 study (also referred to as an "early phase I study" or "pre-phase I study" where a sub-therapeutic dose of drug is administered) at the coordinating center PI's discretion, and should have recovered to eligibility levels from any toxicities
- Treatment with systemic immunostimulatory agents (including, but not limited to, interferon-alpha or interleukin-2 \[aldesleukin\]) within 6 weeks prior to cycle 1, day 1
- Treatment with systemic immunosuppressive medications (including, but not limited to, prednisone, cyclophosphamide, azathioprine, methotrexate, thalidomide, and anti-tumor necrosis factor \[anti-TNF\] agents) within 2 weeks prior to cycle 1, day 1
- Patients who have received acute, low dose, systemic immunosuppressant medications (e.g., a one-time dose of dexamethasone for nausea) may be enrolled
- The use of inhaled corticosteroids and systemic mineralocorticoids (e.g., fludrocortisone) for patients with orthostatic hypotension or adrenocortical insufficiency is allowed
- +68 more criteria
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (42)
Keck Medicine of USC Buena Park
Buena Park, California, 90621, United States
Keck Medicine of USC Koreatown
Los Angeles, California, 90020, United States
Los Angeles General Medical Center
Los Angeles, California, 90033, United States
USC / Norris Comprehensive Cancer Center
Los Angeles, California, 90033, United States
USC Norris Oncology/Hematology-Newport Beach
Newport Beach, California, 92663, United States
Keck Medical Center of USC Pasadena
Pasadena, California, 91105, United States
University of California Davis Comprehensive Cancer Center
Sacramento, California, 95817, United States
Smilow Cancer Hospital-Derby Care Center
Derby, Connecticut, 06418, United States
Smilow Cancer Hospital Care Center-Fairfield
Fairfield, Connecticut, 06824, United States
Smilow Cancer Hospital Care Center - Guilford
Guilford, Connecticut, 06437, United States
Smilow Cancer Hospital Care Center at Saint Francis
Hartford, Connecticut, 06105, United States
Smilow Cancer Center/Yale-New Haven Hospital
New Haven, Connecticut, 06510, United States
Yale University
New Haven, Connecticut, 06520, United States
Yale-New Haven Hospital North Haven Medical Center
North Haven, Connecticut, 06473, United States
Smilow Cancer Hospital-Orange Care Center
Orange, Connecticut, 06477, United States
Smilow Cancer Hospital-Torrington Care Center
Torrington, Connecticut, 06790, United States
Smilow Cancer Hospital Care Center-Trumbull
Trumbull, Connecticut, 06611, United States
Smilow Cancer Hospital-Waterbury Care Center
Waterbury, Connecticut, 06708, United States
Smilow Cancer Hospital Care Center - Waterford
Waterford, Connecticut, 06385, United States
Emory University Hospital Midtown
Atlanta, Georgia, 30308, United States
University of Iowa/Holden Comprehensive Cancer Center
Iowa City, Iowa, 52242, United States
Johns Hopkins University/Sidney Kimmel Cancer Center
Baltimore, Maryland, 21287, United States
National Cancer Institute Developmental Therapeutics Clinic
Bethesda, Maryland, 20892, United States
National Institutes of Health Clinical Center
Bethesda, Maryland, 20892, United States
NCI - Center for Cancer Research
Bethesda, Maryland, 20892, United States
Massachusetts General Hospital Cancer Center
Boston, Massachusetts, 02114, United States
Brigham and Women's Hospital
Boston, Massachusetts, 02115, United States
Beth Israel Deaconess Medical Center
Boston, Massachusetts, 02215, United States
Dana-Farber Cancer Institute
Boston, Massachusetts, 02215, United States
Mayo Clinic in Rochester
Rochester, Minnesota, 55905, United States
Siteman Cancer Center at West County Hospital
Creve Coeur, Missouri, 63141, United States
Washington University School of Medicine
St Louis, Missouri, 63110, United States
Siteman Cancer Center-South County
St Louis, Missouri, 63129, United States
Children's Hospital and Medical Center of Omaha
Omaha, Nebraska, 68114, United States
University of Nebraska Medical Center
Omaha, Nebraska, 68198, United States
NYP/Columbia University Medical Center/Herbert Irving Comprehensive Cancer Center
New York, New York, 10032, United States
Duke University Medical Center
Durham, North Carolina, 27710, United States
Ohio State University Comprehensive Cancer Center
Columbus, Ohio, 43210, United States
University of Pittsburgh Cancer Institute (UPCI)
Pittsburgh, Pennsylvania, 15232, United States
Vanderbilt Breast Center at One Hundred Oaks
Nashville, Tennessee, 37204, United States
Vanderbilt University/Ingram Cancer Center
Nashville, Tennessee, 37232, United States
M D Anderson Cancer Center
Houston, Texas, 77030, United States
Related Publications (1)
Chen AP, Sharon E, O'Sullivan-Coyne G, Moore N, Foster JC, Hu JS, Van Tine BA, Conley AP, Read WL, Riedel RF, Burgess MA, Glod J, Davis EJ, Merriam P, Naqash AR, Fino KK, Miller BL, Wilsker DF, Begum A, Ferry-Galow KV, Deshpande HA, Schwartz GK, Ladle BH, Okuno SH, Beck JC, Chen JL, Takebe N, Fogli LK, Rosenberger CL, Parchment RE, Doroshow JH. Atezolizumab for Advanced Alveolar Soft Part Sarcoma. N Engl J Med. 2023 Sep 7;389(10):911-921. doi: 10.1056/NEJMoa2303383.
PMID: 37672694DERIVED
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Alice P Chen
National Cancer Institute LAO
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- NON RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- NIH
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
May 3, 2017
First Posted
May 5, 2017
Study Start
April 25, 2017
Primary Completion (Estimated)
October 31, 2026
Study Completion (Estimated)
October 31, 2026
Last Updated
April 13, 2026
Record last verified: 2026-04