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Trial Title:
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A Phase II Trial Of Single Agent Cabozantinib In Patients With Locally Advanced Or Metastatic Non-Clear Cell Renal Cell Carcinoma Post Immunotherapy Or Who Are Unsuitable For Immunotherapy
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Trial Acronym:
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UNICAB
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Protocol Number:
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ANZUP 1802
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Trial Design:
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Single arm, Phase II, open label, multi-centre study.
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ANZ Study Chairs:
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Dr David Pook
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ANZ Coordinating Centre:
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Centre for Biostatistics and Clinical Trials
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Trial Coordinator:
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Laura Galletta
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Trial Email:
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Contact.Bact@petermac.org
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Recruitment Aim: |
48 participants
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Patient Population:
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Adults with metastatic or locally advanced/unresectable nccRCC. Key eligibility criteria include:
- ≥18 years of age
- Histologically confirmed nccRCC
- Measurable disease according to RECIST version 1.1
- ECOG ≤2
- Controlled blood pressure
- Adequate liver, renal, and bone marrow function;
- Will not have received prior targeted therapy or chemotherapy, but may have received previous checkpoint immunotherapy on the UNISoN trial (NCT03177239)
- Willing to consent to the use of archival tissue blocks for translational research studies
- Willing to consent to the provision of peripheral blood samples for translational research studies
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Intervention:
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Primary Outcome:
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To evaluate the objective response rate (ORR) associated with cabozantinib.
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Secondary Outcomes:
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- To evaluate the safety of cabozantinib
- To estimate progression free survival (PFS)
- To estimate overall survival (OS)
Exploratory:
- To study the association between clinical outcomes and biomarkers in nccRcc.
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Status:
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Active and recruiting
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Sites Recruiting:
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VIC
- Monash Medical Centre, Clayton
NSW SA
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| Further Information: |
Click here |