Study of XL092+Atezolizumab vs Regorafenib in Subjects with Metastatic Colorectal Cancer
Research type
Research Study
Full title
A Randomized Open-Label Phase 3 Study of XL092 + Atezolizumab vs Regorafenib in Subjects with Metastatic Colorectal Cancer (STELLAR-303)
IRAS ID
1005595
Contact name
Mary Tilson
Contact email
Sponsor organisation
Exelixis, Inc.
Eudract number
2021-003243-21
Clinicaltrials.gov Identifier
Research summary
This is a randomised, multi-centre study taking place in 125 sites worldwide with approx. 600 patients being enroled. Colorectal cancer (CRC) is the third and second most common cancer in men and women, respectively. Although incidence and mortality rates are decreasing, there is an increase among CRC patients under the age of 55. Many patients with metastatic CRC are unlikely to respond to immunotherapy alone, highlighting an unmet medical need for alternative treatments. The purpose of this study is to determine if study treatment, XL092 + atezolizumab, is effective in treating CRC against commercially available medication, regorafenib, in participants who have progressed during or after standard of care therapy. Participants must provide written consent prior to undergoing study procedures. Eligible participants will be randomly assigned to 1 of 2 arms; the experimental arm will receive oral doses of XL092 daily plus an IV infusion of atezolizumab administered as 3-week cycles, and the control arm will receive oral doses of regorafenib daily for the first 21 days of each 28-day cycle. After Screening, site visits for safety will occur every 3 or 4 weeks depending treatment arm. All participants will have tumor assessment every 8 weeks for the first 12 months and then every 12 weeks thereafter. Safety follow up visits will also occur 30 days and 100 days after the last study treatment and then participants will be followed for survival every 12 weeks. This study includes blood sampling, radiographic tumour assessments and health questionnaires. An Independent Data Monitoring Committee will be established to monitor safety of the study on a regular basis. Participants’ total time in the study is expected to last 5 months however true study duration may be longer or shorter due to deviance from assumptions on participant enrolment and other aspects of study conduct.
Exelixis Inc., located in the USA, will organise and pay for this study.REC name
HSC REC A
REC reference
22/NI/0148
Date of REC Opinion
14 Nov 2022
REC opinion
Further Information Favourable Opinion