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Enrollment completed for phase 3 trial of cabozantinib plus atezolizumab in renal cell carcinoma


Patient enrollment is now complete for the phase 3 CONTACT-03 trial exploring the combination of the multikinase inhibitor cabozantinib (Cabometyx) with the PD-L1 inhibitor atezolizumab (Tecentriq) in patients with advanced renal cell carcinoma (RCC) and prior exposure to an immune-checkpoint inhibitor.1

CONTACT-03 is specifically accruing patients with inoperable, locally advanced or metastatic RCC with disease progression after receiving an immune checkpoint inhibitor as the immediate prior therapy.

“With multiple new treatment options approved for kidney cancer over the last decade, there is a need to better understand how therapies can be used sequentially to help address critical unmet needs for this patient population,” Michael M. Morrissey, PhD, president and chief executive officer, Exelixis, the developer of cabozantinib, stated in a news release. “Now that CONTACT-03 has completed enrollment, we look forward to sharing initial results when the data mature, which will offer insight into the potential of cabozantinib in combination with atezolizumab for patients who have progressed following treatment with an immune checkpoint inhibitor.”

The open-label, global, phase 3 CONTACT-03 trial (NCT04338269) is randomizing 523 patients in a 1:1 ratio to cabozantinib alone or in combination with atezolizumab. The enrollment goal of the study is 500 patients. The coprimary study end points are overall survival and progression-free survival (PFS), with secondary end points including objective response rate and duration of response.

In the genitourinary cancer treatment paradigm, cabozantinib is currently approved by the FDA as a monotherapy for the treatment of patients with advanced RCC. Atezolizumab has several approved indications in urothelial carcinoma, but none yet in RCC.

According toExelixis, the design of the CONTACT-03 study was informed by the ongoing phase 1b COSMIC-021 trial (NCT03170960), which is exploring cabozantinib plus atezolizumab across a variety of solid tumors.

Combination therapy with immune checkpoint inhibitors and tyrosine kinase inhibitors (TKIs) has been an area of intense focus in the RCC paradigm. For example, in April 2019, the FDA approved the PD-1 inhibitor pembrolizumab for use in combination with the TKI axitinib (Inlyta) for the first-line treatment of patients with advanced RCC.

The approval was supported by findings from the phase 3 KEYNOTE-426 trial,2 in which the combination led to a 47% (HR, 0.53; P <.0001) reduction in the risk of death versus sunitinib (Sutent) in patients with advanced RCC. The immunotherapy/TKI combination also significantly improved overall response and PFS compared with sunitinib alone.

Another immunotherapy/TKI regimen, avelumab plus axitinib, was approved by the FDA in May 2019 for the frontline treatment of patients with advanced RCC. The approval was based on findings from the phase 3 JAVELIN Renal 101 trial,3 which showed that the combination was associated with a 31% reduction in the risk of disease progression or death compared with sunitinib in patients with treatment-naïve, advanced RCC.

Beyond CONTACT-03 and COSMIC-021, another ongoing trial exploring cabozantinib/atezolizumab is the phase 3 randomized, open-label CONTACT-02 study (NCT04446117) comparing the combination with a second novel hormone therapy (NHT; abiraterone acetate [Zytiga], enzalutamide [Xtandi], etc) in patients with metastatic castration-resistant prostate cancer (mCRPC) who previously received 1 NHT to treat metastatic castration-sensitive prostate cancer, non-metastatic CRPC, or mCRPC.


1. Exelixis Announces Enrollment Completion in Phase 3 CONTACT-03 Pivotal Trial of Cabozantinib in Combination with an Immune Checkpoint Inhibitor in Previously Treated Metastatic Renal Cell Carcinoma. Published online January 5, 2021. Accessed January 5, 2021. https://bit.ly/3qOT0s9.

2. FDA Approves Merck’s KEYTRUDA (pembrolizumab) in Combination With Inlyta® (axitinib) as First-Line Treatment for Patients With Advanced Renal Cell Carcinoma (RCC). Merck. Published April 22, 2019. https://bit.ly/2IKrjMM. Accessed April 22, 2019.

3. FDA Approves Bavencio (Avelumab) Plus Inlyta (Axitinib) Combination for Patients With Advanced Renal Cell Carcinoma. Pfizer Oncology. Published May 14, 2019. https://on.pfizer.com/2HtdCzF. Accessed May 14, 2019.

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