Investigating Solid Tumors


Phase 3 Randomized, Open-Label Study in Metastatic Colorectal Cancer

Phase 3 Randomized, Open-Label Study in Advanced or Metastatic Non–Clear Cell Renal Cell Carcinoma

Exelixis is committed to solid tumor research to help find effective treatments for these diseases. We have recently started 2 new solid tumor studies, STELLAR-303 in metastatic colorectal cancer (CRC) and STELLAR-304 in metastatic non–clear cell renal cell carcinoma (nccRCC), involving participants from around the world.

epidemiology of CRC

CRC is the second most common cancer in women and the third most common cancer in men,1 and 25-50% of patients with CRC will go on to develop distant liver metastases during the course of their illness.3 The risk of CRC increases with age, with many patients over age 60 at the time of diagnosis.4 While the overall incidence and mortality rates are declining due to changing patterns in risk factors and uptake of CRC screening, there has been an increase in incidence among younger adults, particularly those under 50 years of age.4

epidemiology of RCC

The most common histological variant of RCC is clear cell RCC (ccRCC), which makes up ~75% of all RCC, and nccRCC encompasses the remaining ~25% of tumors.5 For patients with nccRCC, there have been no dedicated, randomized, phase 3 studies to adequately characterize benefit, thus many oncology clinical practice guidelines recommend enrollment in clinical trials as the preferred strategy for patients with nccRCC.6,7

The goal of these studies is to determine if an orally bioavailable inhibitor of several tyrosine kinases implicated in tumor growth, angiogenesis, and immune cell regulation, in combination with immunotherapy, could be a successful treatment for metastatic CRC and nccRCC in the future. This website provides information about the STELLAR-303 and STELLAR-304 clinical trials for healthcare professionals who may be interested in enrolling their patients.


  1. World Health Organization. International Agency for Research on Cancer. Available from: Estimated age-standardized incidence and mortality rates (world) in 2020. Accessed March 23, 2023.
  2. Globocan 2020: Colorectal cancer. Available from: Accessed March 23, 2023.
  3. Martin J, et al. Colorectal liver metastases: Current management and future perspectives. World J Clin Oncol. 2020;11(10):761-808.
  4. Siegel RL, et al. Colorectal cancer statistics, 2020. CA A Cancer J Clin. 2020;70:145-164.
  5. Hsieh JJ, et al. Renal cell carcinoma. Nat Rev Dis Primers. 2017;3:17009.
  6. Motzer RJ, et al. Kidney cancer, Version 3.2022, NCCN Clinical Practice Guidelines in Oncology. J Natl Compr Canc Netw. 2022;20(1):71-90.
  7. Escudier B, et al. Renal cell carcinoma: ESMO Clinical Practice Guidelines for diagnosis, treatment and follow-up. Ann Oncol. 2019;30(5):706-720.

To learn more about these trials, go to, or contact Exelixis Medical Information at