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Durvalumab + Doxorubicin in Advanced Soft Tissue Sarcoma
NCT03802071Phase 2
Key facts
- Status
- Completed
- Start
- Sep 2019
- Primary completion
- Aug 2022
- Countries
- 1
- Sponsor
- Yonsei University
- Modality
- Antibody Conjugates, Engineered Antibody Formats, PD-1/PD-L1 Inhibitors
- Drugs
- durvalumab
- Conditions
- soft tissue sarcoma (STS)
01
Overview
Phase 2, open-label, single-arm trial of durvalumab in soft tissue sarcoma (STS), sponsored by Yonsei University. Primary endpoint: Adverse Events at 3 weeks. Started Sep 2019; status: completed.
02
Design
1 arm- Study design
- Non-randomizedOpen-labelSingle group
Durvalumab+doxorubicin combination
Durvalumab 1500mg IV Doxorubicin 75mg/m2 IV D1 Q3weeks (up to 8cycles)
03
Who it enrols
Patients with histologically confirmed soft tissue sarcoma (excluding Kaposi's or GIST), ECOG 0-1, adequate organ function, LVEF >= 45%, and no prior treatment with anthracyclines, PD-1/PD-L1 inhibitors, or PDGFR inhibitors.
04
Endpoints
Primary
Adverse Events
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