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

Part of paid clinical trials in Buena Park, California.

Sponsor
National Cancer Institute (NCI)
Study ID
NCT03141684
Phase
PHASE2
Status
Active Not Recruiting

Conditions

  • Metastatic Alveolar Soft Part Sarcoma
  • Unresectable Alveolar Soft Part Sarcoma

Eligibility Criteria

Sex
ALL
Age
2 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Atezolizumab — DRUG
    Given IV
  • Bevacizumab — BIOLOGICAL
    Given IV
  • Biospecimen Collection — PROCEDURE
    Undergo collection of blood and urine
  • Computed Tomography — PROCEDURE
    Undergo CT

Study Details

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.

Key Dates

Start date
Apr 25, 2017
Status verified
Apr 2026
Primary completion
Oct 31, 2026
Completion
Oct 31, 2026

Study Design

Enrollment
63 participants (estimated)
Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: Arm I (atezolizumab)
    Patients 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)
  • Experimental: Arm II (atezolizumab, bevacizumab)
    Patients 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.

Primary Outcome Measure

Objective response rate [ Time Frame: Up to 4 weeks after the last dose of study treatment ]

Locations (42)

FacilityCityStateZIPSite coordinators
Keck Medicine of USC Buena ParkBuena ParkCalifornia90621-
Keck Medicine of USC KoreatownLos AngelesCalifornia90020-
Los Angeles General Medical CenterLos AngelesCalifornia90033-
USC / Norris Comprehensive Cancer CenterLos AngelesCalifornia90033-
USC Norris Oncology/Hematology-Newport BeachNewport BeachCalifornia92663-
Keck Medical Center of USC PasadenaPasadenaCalifornia91105-
University of California Davis Comprehensive Cancer CenterSacramentoCalifornia95817-
Smilow Cancer Hospital-Derby Care CenterDerbyConnecticut06418-
Smilow Cancer Hospital Care Center-FairfieldFairfieldConnecticut06824-
Smilow Cancer Hospital Care Center - GuilfordGuilfordConnecticut06437-
Smilow Cancer Hospital Care Center at Saint FrancisHartfordConnecticut06105-
Smilow Cancer Center/Yale-New Haven HospitalNew HavenConnecticut06510-
Yale UniversityNew HavenConnecticut06520-
Yale-New Haven Hospital North Haven Medical CenterNorth HavenConnecticut06473-
Smilow Cancer Hospital-Orange Care CenterOrangeConnecticut06477-
Smilow Cancer Hospital-Torrington Care CenterTorringtonConnecticut06790-
Smilow Cancer Hospital Care Center-TrumbullTrumbullConnecticut06611-
Smilow Cancer Hospital-Waterbury Care CenterWaterburyConnecticut06708-
Smilow Cancer Hospital Care Center - WaterfordWaterfordConnecticut06385-
Emory University Hospital MidtownAtlantaGeorgia30308-
University of Iowa/Holden Comprehensive Cancer CenterIowa CityIowa52242-
Johns Hopkins University/Sidney Kimmel Cancer CenterBaltimoreMaryland21287-
National Cancer Institute Developmental Therapeutics ClinicBethesdaMaryland20892-
National Institutes of Health Clinical CenterBethesdaMaryland20892-
NCI - Center for Cancer ResearchBethesdaMaryland20892-
Beth Israel Deaconess Medical CenterBostonMassachusetts02215-
Brigham and Women's HospitalBostonMassachusetts02115-
Dana-Farber Cancer InstituteBostonMassachusetts02215-
Massachusetts General Hospital Cancer CenterBostonMassachusetts02114-
Mayo Clinic in RochesterRochesterMinnesota55905-
Siteman Cancer Center at West County HospitalCreve CoeurMissouri63141-
Siteman Cancer Center-South CountySt LouisMissouri63129-
Washington University School of MedicineSt LouisMissouri63110-
Children's Hospital and Medical Center of OmahaOmahaNebraska68114-
University of Nebraska Medical CenterOmahaNebraska68198-
NYP/Columbia University Medical Center/Herbert Irving Comprehensive Cancer CenterNew YorkNew York10032-
Duke University Medical CenterDurhamNorth Carolina27710-
Ohio State University Comprehensive Cancer CenterColumbusOhio43210-
University of Pittsburgh Cancer Institute (UPCI)PittsburghPennsylvania15232-
Vanderbilt Breast Center at One Hundred OaksNashvilleTennessee37204-
Vanderbilt University/Ingram Cancer CenterNashvilleTennessee37232-
M D Anderson Cancer CenterHoustonTexas77030-

Find similar trials in Buena Park, CA

Related Studies