The Phase 3 Sagittarius Trial (NCT06490536) for Nivolumab reached its primary completion on March 1, 2026. This trial investigates novel therapeutic strategies for patients with Stage II and Stage III colon cancer.

Background

Colon cancer is a significant cause of cancer-related mortality, particularly with high recurrence rates observed in patients with Stage II high-risk and Stage III disease due to the presence of undetectable micro-metastases. The Sagittarius Trial aims to address this challenge by exploring whether therapy guided by tumor genetics and liquid biopsy (LB) can improve outcomes and quality of life for these patients compared to conventional treatment approaches. Liquid biopsy is utilized to detect residual cancer DNA following surgery and to monitor treatment response.

Trial design

The Sagittarius Trial (NCT06490536) is a Phase 3 study with an estimated enrollment of 700 participants. The trial focuses on patients diagnosed with Stage II colon cancer and Stage III colon cancer. The primary objective is to demonstrate that therapy based on tumor genetics and liquid biopsy improves outcomes and quality of life for high-risk Stage II and Stage III colon cancer patients when compared to conventional therapy. Interventions listed include oxaliplatin, capecitabine, folinic acid, fluorouracil, and temozolomide.

What this means

The primary completion of the Sagittarius Trial marks a significant milestone in the study of advanced colon cancer treatment. While specific results are not yet available, the completion of this phase indicates that the trial has progressed through its primary data collection period. The study's focus on integrating tumor genetics and liquid biopsy into treatment decisions for high-risk Stage II and Stage III colon cancer patients highlights an evolving area of oncology research aimed at personalizing therapy and potentially improving patient outcomes and quality of life.

Source

Information regarding the primary completion of the Sagittarius Trial (NCT06490536) was obtained from the ClinicalTrials.gov database. The trial record was updated on March 1, 2026, on clinicaltrials.gov.