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NCT03685448: UNICAB

ANZUP - Non-clear Cell Post Immunotherapy CABozantinib (UNICAB)

Completed Phase 2 Last updated 8 August 2025
What this trial tests

Phase 2 trial testing Cabozantinib in Renal Cell Carcinoma in 35 participants. Completed in 4 June 2025.

Timeline
11 April 2019
Primary endpoint
30 December 2024
4 June 2025

Quick facts

Lead sponsorAustralian and New Zealand Urogenital and Prostate Cancer Trials Group
PhasePhase 2
StatusCompleted
Study typeINTERVENTIONAL
Allocationna
Designsingle group
Maskingnone
Primary purposetreatment
Enrollment35
Start date11 April 2019
Primary completion30 December 2024
Estimated completion4 June 2025
Sites11 locations across Australia

Drugs / interventions tested

Conditions studied

Sponsor

Australian and New Zealand Urogenital and Prostate Cancer Trials Group — full company profile →

Who can join

18 and older, any sex, with Renal Cell Carcinoma or Papillary Renal Cell Carcinoma Type 1. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

Renal cell carcinoma (RCC) is the 9th most common cancer in Australia, the 10th most common cancer in Western populations.\~75% of kidney cancers are clear-cell renal cell carcinomas (ccRCC). Many patients present with advanced or unresectable disease at diagnosis and a number of treatments are now available for metastatic ccRCC included vascular endothelial growth factor receptor tyrosine kinase inhibitors (VEGFR TKIs), mTOR inhibitors, and cytokines. More recently first line use of immunotherapy demonstrated improved survival with checkpoint inhibitors. While many patients benefit from first-line treatment, progression is inevitable and these treatments remain on the whole palliative. Second-line VEGFR TKIs, mTOR inhibitors and immunotherapy have some benefit but in a smaller increment than first-line treatment. While \~75% of kidney cancers are the clear-cell variant, \~25% of kidney cancers are non-clear cell histology (nccRCC) and include papillary, chromophobe, sarcomatoid, collecting duct carcinoma, Xp11 translocation carcinoma and unclassified. Patients with non-ccRCC have significantly lower response rates and poorer median progression-free survival and overall survival than those with ccRCC. Non clear cell histologies have largely been excluded from large phase III randomised clinical trials and therefore the optimal treatment and sequencing of therapies for these patients remains unclear. Despite recent unprecedented advances in treatment, there continues to be an unmet need to improve outcomes for patients with previously untreated, unresectable or metastatic renal cell carcinoma. This is particularly relevant in non-clear cell RCC. Because it is a rarer subtype of metastatic renal cell carcinoma, it is more challenging to study, and treatment efficacy data is sparse. The research project is testing a new treatment for participants with locally advanced or metastatic non-clear cell kidney cancer. The new treatment involves a drug called Cabozantinib (also known as Cabometyx). This drug has been used previously in many cancers, including clear cell kidney cancer and thyroid cancer. The purpose of this study is to test the effectiveness (how well the drug works), safety, and tolerability of Cabozantinib. Cabozantinib is a anti-cancer drug that works by blocking cancer cell growth. It blocks particular proteins called protein kinases on cancer cells. Protein kinases encourage the cancer to grow. Cabozantinib is called a multi kinase inhibitor because it blocks a number of these proteins. How well cabozantinib works in cancer of the kidney will be tested by measuring the change in size of your tumours that are seen on CT scans. Cabozantinib is approved to treat clear cell kidney cancer and thyroid cancer in Australia. It has not been tested in people with non-clear cell kidney cancer. About 48 participants with non-clear cell kidney cancer are expected to participate in this study, from Australia. Even though this study may be suitable for you, it is possible that you may not be enrolled in this study. This research study has been initiated by Dr. David Pook, is being conducted in collaboration with the Centre for Biostatistics and Clinical Trials (BaCT) and sponsored in Australia by the Australian and New Zealand Urogenital and Prostate (ANZUP) Cancer Trials Group Pty Ltd. Ipsen is supplying

Publications & conference data

6 peer-reviewed publications reference this trial (live from Europe PMC):

  1. Comparative genomics incorporating translocation renal cell carcinoma mouse model reveals molecular mechanisms of tumorigenesis.
    Prakasam G, Mishra A, Christie A, Miyata J, et al · · 2024 · cited 22× · PMID 38386415 · DOI 10.1172/jci170559
  2. MiTF/TFE Translocation Renal Cell Carcinomas: From Clinical Entities to Molecular Insights.
    Simonaggio A, Ambrosetti D, Verkarre V, Auvray M, et al · · 2022 · cited 22× · PMID 35886994 · DOI 10.3390/ijms23147649
  3. Tyrosine Kinase Inhibitors in the Treatment of Metastasised Renal Cell Carcinoma-Future or the Past?
    Michaelis J, Grabbert M, Sigle A, Yilmaz M, et al · · 2022 · cited 17× · PMID 35954446 · DOI 10.3390/cancers14153777
  4. Mini-Review: Cabozantinib in the Treatment of Advanced Renal Cell Carcinoma and Hepatocellular Carcinoma.
    Rathi N, Maughan BL, Agarwal N, Swami U. · · 2020 · cited 12× · PMID 32547210 · DOI 10.2147/cmar.s202973
  5. Systemic Treatment for Advanced and Metastatic Non-Clear Cell Renal Cell Carcinoma: Examining Modern Therapeutic Strategies for a Notoriously Challenging Malignancy.
    Drobner J, Portal D, Runcie K, Yang Y, et al · · 2023 · cited 7× · PMID 37789902 · DOI 10.15586/jkcvhl.v10i3.295
  6. Durable Remission with Immunotherapy in a Patient with Sarcomatoid Renal Cell Carcinoma.
    Nwabundo A, Damilola G, Olabisi AO, Ishmael J. · · 2021 · cited 1× · PMID 34765405 · DOI 10.15586/jkcvhl.v8i4.168

Verify or expand the search:

Other trials of Cabozantinib

Trials testing the same drug.

Other recruiting trials for Renal Cell Carcinoma

Currently open trials in the same condition.

Other Australian and New Zealand Urogenital and Prostate Cancer Trials Group trials

Trials by the same sponsor.

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Data sources for this page

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