STELLAR 303

Active, Not Recruiting

Phase 3 Randomized, Open-Label Study of Zanzalintinib (XL092) With Atezolizumab vs Regorafenib in Metastatic Colorectal Cancer

THE COMBINATION OF zanzalintinib AND ATEZOLIZUMAB IS NOT APPROVED FOR THE USE UNDER INVESTIGATION IN THIS TRIAL. SAFETY AND EFFICACY HAVE NOT BEEN ESTABLISHED.

Study Overview
Key Eligibility Criteria
Key Endpoints
Participating Sites

Study Overview

Approximately 874 eligible patients with MSS/MSI-low mCRC who have progressed during or after, or are intolerant to, SOC therapy will be randomly assigned to zanzalintinib in combination with atezolizumab or regorafenib monotherapy to evaluate the efficacy of the combination therapy on duration of OS vs regorafenib monotherapy. Primary analysis is non-liver metastases (NLM) patients. Approximately 350 NLM patients will be enrolled, while enrollment of patients with liver metastases will be capped at approximately 524.

Chart explaining phase 3, randomized, open-label study of zanzalintinib with atezolizumab vs regorafenib in patients with MSS/MSI-low mCRC

Key Eligibility Criteria

MSS/MSI-low metastatic colorectal adenocarcinoma with measurable disease
Known RAS status
Progressed, refractory, or intolerant to all of the following SOC regimens for mCRC:

Fluoropyrimidine, irinotecan, and oxaliplatin, ± anti-VEGF mAb
Anti-EGFR mAb for RAS^WT
BRAF inhibitor for known BRAF V600E mutations

Progression ≤4 months following the last dose of SOC regimen
No prior treatment with zanzalintinib, regorafenib, trifluridine/tipiracil, or PD-L1/PD-1–targeting ICIs

Key Endpoints

Primary Endpoint

OS in NLM patients

Secondary Endpoints

OS in all patients
PFS by investigator
ORR by investigator
DOR by investigator

Exploratory Endpoint

HRQoL by EORTC QLQ‑C30/QLQ‑CR29 and EQ‑5D‑5L

DOR, duration of response; EGFR, epithelial growth factor receptor; EORTC QLQ-C30/QLQ-CR29, European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire–Core 30/Colorectal 29; EQ-5D-5L, EuroQoL health questionnaire instrument; HRQoL, health-related quality of life; ICI, immune checkpoint inhibitor; IV, intravenous; mAb, monoclonal antibody; mCRC, metastatic colorectal cancer; MSl-low, microsatellite instability–low; MSS, microsatellite stable; NLM, non-liver metastases; ORR, objective response rate; OS, overall survival; PD-L1, programmed death receptor-1 ligand; PFS, progression-free survival; q3w, once every 3 weeks; qd, once daily; SOC, standard of care; VEGF, vascular endothelial growth factor; WT, wild-type.

Participating Sites

STELLAR-303 will be conducted in North America, Europe, Middle East, and Asia Pacific. Call 1-888-393-5494 (toll-free) or 1-303-389-1847 for specific location and site information and to confirm whether sites near you are still enrolling new patients.

Currently open or planned clinical site cities:

Trial sites may stop enrolling patients at any time. Please check back if you do not see a trial site located near you.

To learn more about this trial, go to clinicaltrials.gov and search for NCT05425940, or contact Exelixis Medical Information at 1-888-393-5494 (toll-free),
1-303-389-1847, or medinfo@exelixis.com.