UNICAB

Kidney — In Follow-up

UNICAB

This study aims to find how safe, tolerable and effective a new treatment called Cabozantinib is for non-clear cell kidney cancer.

All patients will take cabozantinib orally every day, until the medication is no longer effective. There is no placebo (inactive treatment), which means that everyone who takes part in the trial will receive the active cabozantinib drug. Cabozantinib is an anti-cancer drug that works by blocking cancer cell growth. Cabozantinib has previously been used in the treatment of many cancers, including clear cell kidney cancer and thyroid cancer.

We thank and acknowledge Ipsen for providing funding and study drug for the UNICAB Trial.

If you think this trial might be right for you, please ask your doctor.

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

Cancer Type

Kidney

Trial Status

In Follow-up

Protocol Number

ANZUP 1802

Trial Email

Contact.Bact@petermac.org

Co-ordinating centre

Centre For Biostatistics And Clinical Trials (BACT)

Study Chair

Associate Professor David Pook

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