UNICAB

Trial Title:

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

Trial Acronym:

UNICAB

Protocol Number:

ANZUP 1802

Trial Design:

Single arm, Phase II, open label, multi-centre study.

ANZ Study Chairs:

Dr David Pook

ANZ Coordinating Centre:

Centre for Biostatistics and Clinical Trials

Trial Coordinator:

Laura Galletta

Trial Email:

Contact.Bact@petermac.org 


Recruitment Aim: 
 
48 participants 

Patient Population:


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  

Intervention:

 

Primary Outcome:

To evaluate the objective response rate (ORR) associated with cabozantinib.

Secondary Outcomes:

  • 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.

Status:

Active and recruiting

Sites Recruiting:

VIC
  • Monash Medical Centre, Clayton
NSW
  • Border Medical Oncology
SA
  • Adelaide Cancer Centre
Further Information: Click here
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