Exelixis and Merck Collaborate on Phase 3 Trial for Colorectal Cancer Treatment
Exelixis Announces Clinical Development Collaboration with Merck for Phase 3 STELLAR-316 Pivotal Trial for Patients with Colorectal Cancer

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Exelixis, Inc. has partnered with Merck to conduct the STELLAR-316 trial, a Phase 3 study evaluating the combination of zanzalintinib and KEYTRUDA QLEXTM for patients with resected stage II/III colorectal cancer. The trial aims to assess disease-free survival in patients who have tested positive for molecular residual disease.
- 01The STELLAR-316 trial will focus on patients with resected stage II/III colorectal cancer who are MRD+.
- 02The primary endpoint of the trial is disease-free survival, with secondary endpoints including circulating tumor DNA clearance.
- 03Exelixis expects to begin the STELLAR-316 trial in mid-2026.
- 04Zanzalintinib is an investigational oral kinase inhibitor targeting multiple oncogenic pathways.
- 05Colorectal cancer is the third most common cancer in the U.S., with approximately 159,000 new cases expected in 2026.
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Exelixis, Inc. has announced a collaboration with Merck to conduct the STELLAR-316 trial, a Phase 3 pivotal study aimed at evaluating the efficacy of zanzalintinib in combination with KEYTRUDA QLEXTM (pembrolizumab and berahyaluronidase alfa-pmph) for patients with resected stage II/III colorectal cancer (CRC). This trial will specifically target patients who have tested positive for molecular residual disease (MRD+) following definitive therapy and have no radiographic evidence of disease. The primary endpoint of the trial will be disease-free survival, while secondary endpoints will include the clearance of circulating tumor DNA. Exelixis plans to initiate the trial in mid-2026, following a previous collaboration with Natera to utilize its SignateraTM assay for patient enrollment. Colorectal cancer remains a significant health concern, being the third most common cancer in the U.S., with an estimated 159,000 new diagnoses in 2026. Zanzalintinib is a novel oral kinase inhibitor that targets several oncogenic pathways, and its development program includes ongoing trials for various cancers. This collaboration represents a strategic step forward in advancing treatment options for patients at high risk of CRC recurrence.
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The STELLAR-316 trial could lead to new treatment options for colorectal cancer patients, potentially improving survival rates and quality of life.
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