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Atezolizumab Plus Tivozanib in Immunologically Cold Tumor Types
NCT05000294Phase 2
Key facts
- Status
- Recruiting
- Start
- Dec 2021
- Primary completion
- Dec 2026
- Countries
- 1
- Sponsor
- University of Florida
- Modality
- Fragment-Derived Small Molecules, Monoclonal Antibodies, Orthosteric Ligands
- Conditions
- cholangiocarcinoma (CCA)gallbladder cancerbreast cancerNeuroendocrine Neoplasm (NEN)ovarian cancer
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Overview
Phase 2, open-label, single-arm trial of atezolizumab and tivozanib in cholangiocarcinoma (CCA), gallbladder cancer, breast cancer and 6 more, sponsored by University of Florida. Primary endpoint: Objective Response Rate at 30 months. Started Dec 2021; status: recruiting.
02
Design
1 arm- Study design
- Non-randomizedOpen-labelSingle group
Atezolizumab + Tivozanib
Atezolizumab IV + Tivozanib oral
03
Who it enrols
Adults with advanced/metastatic 'cold' tumors (bile duct, gallbladder, breast, NET, ovarian, pancreatic, sarcoma, vulvar, prostate) who failed prior systemic therapy. Excludes MSI-H/dMMR, TMB >= 10, prior VEGFR TKIs or checkpoint inhibitors.
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Endpoints
Primary
Objective Response Rate
Secondary
Progression-Free Survival
Overall Survival
Disease Control Rate
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