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Atezolizumab in Treating Patients With Newly Diagnosed and Metastatic Alveolar Soft Part Sarcoma That Cannot Be Removed by Surgery

Metastatic Alveolar Soft Part Sarcoma Clinical Trial

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

Clinical Trial Summary

This phase II trial studies how well atezolizumab 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 and cannot be removed by surgery. Monoclonal antibodies, such as atezolizumab, may allow the immune system cells to find and kill the tumor cells.

Clinical Trial 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 >= 6 years.

SECONDARY OBJECTIVES:

I. Determine duration of response (DOR) using RECIST v 1.1 and/or change in clinical symptoms.

II. Measure progression-free survival (PFS) time as determined by investigator using RECIST v 1.1.

III. At the Clinical Center, National Cancer Institute (NCI), only: correlate response with expression of potential immune biomarkers in paired biopsies.

IV. Compare the RECIST v 1.1 versus (vs) the immune-related response criteria (irRC) in patients with ASPS on atezolizumab.

OUTLINE:

Patients receive atezolizumab intravenously (IV) over 30-60 minutes on day 1. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity.

After completion of study treatment, patients are followed up for 4 weeks. ;

Study Design

Related Conditions & MeSH terms

Clinical Trial Details
NCT number NCT03233698
Study type Interventional
Source National Cancer Institute (NCI)
Contact
Status Recruiting
Phase Phase 2
Start date March 3, 2017
Completion date December 1, 2018
View Details
See also
  Status Clinical Trial Phase
Not yet recruiting NCT06066138 - A Study of Therapeutic Drug Monitoring-Based Atezolizumab Dosing Phase 1
Recruiting NCT05333458 - Testing Atezolizumab With or Without Selinexor in Patients >= 18 Years Old With Alveolar Soft Part Sarcoma, the Axiom Study Phase 2
Active, not recruiting NCT03141684 - Testing Atezolizumab Alone or Atezolizumab Plus Bevacizumab in People With Advanced Alveolar Soft Part Sarcoma Phase 2
Terminated NCT02113826 - Pazopanib for Metastatic Alveolar Soft Part Sarcoma Phase 2