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Randomized Phase II Study of Atezolizumab plus SBRT vs SBRT Alone in Oligometastatic Soft Tissue Sarcomas
2017-004239-35Phase 2
Key facts
- Status
- Active
- Start
- Aug 2019
- Countries
- 1
- Sponsor
- Centre Antoine Lacassagne
- Modality
- Monoclonal Antibodies → Antibody-Based Therapeutics, Recombinant Proteins and Enzymes
- Drugs
- atezolizumab
- Conditions
- soft tissue sarcoma (STS)
01
Overview
Phase 2, randomised trial of atezolizumab in soft tissue sarcoma (STS) (2 arms), sponsored by Centre Antoine Lacassagne. Primary endpoint: Progression-free survival rate at 6 months. Started Aug 2019; status: active.
02
Design
2 arms- Study design
- Randomized
Atezolizumab + SBRT
Patients receive concurrent atezolizumab with high-dose stereotactic body radiation therapy.
SBRT alone
Patients receive high-dose stereotactic body radiation therapy without immunotherapy.
03
Who it enrols
Adult patients with histologically proven oligometastatic soft tissue sarcoma (leiomyosarcoma, liposarcoma, undifferentiated sarcoma) are eligible; participation in another investigational study or use of investigational drugs/devices within 4 weeks prior to randomization is an exclusion.
04
Endpoints
Primary
Progression-free survival rate at 6 months
Secondary
Progression-free survival by immune response criteria
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