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PD-L1 Inhibitor

XL092 + Atezolizumab vs Regorafenib for Colorectal Cancer (STELLAR-303 Trial)

Phase 3
Recruiting
Research Sponsored by Exelixis
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Available archival tumor biopsy material. If archival tissue is unavailable, must provide fresh tumor tissue biopsy prior to randomization
Female subjects of childbearing potential must not be pregnant at screening
Timeline
Screening 3 weeks
Treatment Varies
Follow Up approximately 26 months after the first subject is randomized.
Awards & highlights

STELLAR-303 Trial Summary

This trial is testing a new combination therapy for people with metastatic colorectal cancer who have progressed after or are intolerant to standard-of-care therapy.

Who is the study for?
Adults with metastatic colorectal cancer that's not highly unstable at the genetic level (MSS/MSI-low) can join if they've had progression after standard treatments. They need a confirmed diagnosis, RAS status known, and must have recovered from previous treatment side effects to a mild level. They should be relatively fit (ECOG 0-1), have measurable disease, and provide tumor biopsy material.Check my eligibility
What is being tested?
The trial is testing XL092 in combination with Atezolizumab against Regorafenib alone in patients whose colorectal cancer has worsened despite standard care. It's randomized and open-label, meaning participants know which treatment they're getting.See study design
What are the potential side effects?
Possible side effects include fatigue, diarrhea, high blood pressure for Regorafenib; while XL092 + Atezolizumab may cause immune-related reactions like rash or liver inflammation, infusion reactions, tiredness and loss of appetite.

STELLAR-303 Trial Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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I can provide a sample of my tumor, either from previous or new biopsies.
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I am not pregnant.
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I am receiving the standard cancer treatment available in my country.
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My metastatic colorectal cancer has worsened or not responded to standard treatments.
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My colorectal cancer is not MSI-high or dMMR based on tissue tests.
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I am 18 years old or older.
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I am fully active or can carry out light work.
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My cancer's RAS status has been tested.
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My cancer is confirmed as colon or rectum adenocarcinoma.

STELLAR-303 Trial Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~approximately 26 months after the first subject is randomized.
This trial's timeline: 3 weeks for screening, Varies for treatment, and approximately 26 months after the first subject is randomized. for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Secondary outcome measures
Overall Survival
Other outcome measures
Duration of Response (DOR) as assessed by the Investigator per RECIST 1.1
Objective Response Rate (ORR) as assessed by the Investigator per RECIST 1.1
Progression-Free Survival (PFS) as assessed by the Investigator per RECIST 1.1

STELLAR-303 Trial Design

2Treatment groups
Experimental Treatment
Active Control
Group I: Experimental ArmExperimental Treatment2 Interventions
Subjects with mCRC will receive XL092 + atezolizumab
Group II: Control ArmActive Control1 Intervention
Subjects with mCRC will receive active comparator of regorafenib
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Atezolizumab
2017
Completed Phase 3
~5860

Find a Location

Who is running the clinical trial?

ExelixisLead Sponsor
117 Previous Clinical Trials
18,677 Total Patients Enrolled

Media Library

Atezolizumab (PD-L1 Inhibitor) Clinical Trial Eligibility Overview. Trial Name: NCT05425940 — Phase 3
Colorectal Cancer Research Study Groups: Experimental Arm, Control Arm
Colorectal Cancer Clinical Trial 2023: Atezolizumab Highlights & Side Effects. Trial Name: NCT05425940 — Phase 3
Atezolizumab (PD-L1 Inhibitor) 2023 Treatment Timeline for Medical Study. Trial Name: NCT05425940 — Phase 3

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Are there any more volunteers needed for this research project?

"The clinicaltrials.gov website reveals that this study is still recruiting participants. The listing was first put up on September 7th, 2022 and has been edited as recently as October 14th, 2022."

Answered by AI

How many study participants are there in total?

"That is correct. The clinicaltrials.gov website lists this trial as currently recruiting. This trial was originally posted on September 7th, 2020 and was last updated on October 14th, 2020. The trial is searching for 600 participants at 8 sites."

Answered by AI

Are there any negative XL092 side effects that have been reported?

"There is both pre-existing clinical data supporting the safety of XL092 as well as efficacy, which is why it received a score of 3."

Answered by AI

Where are the medical facilities that are testing this new drug?

"Exelixis Clinical Site #7 in Cincinnati, Exelixis Clinical Site #6 in New Orleans, and Exelixis Clinical Site #3 in Joliet are 3 of the 8 active locations for this study."

Answered by AI

Who else is applying?

What site did they apply to?
Exelixis Clinical Site #3
Exelixis Clinical Site #7
Exelixis Clinical Site #24
Other
What portion of applicants met pre-screening criteria?
Met criteria
What state do they live in?
Arizona
How many prior treatments have patients received?
1
Recent research and studies
clinicaltrials.govStudy
Study of XL092 + Atezolizumab vs Regorafenib in Subjects With Metastatic Colorectal Cancer
2022. "Study of XL092 + Atezolizumab vs Regorafenib in Subjects With Metastatic Colorectal Cancer". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT05425940.
All > Colorectal Cancer Glendale
~386 spots leftby Aug 2025
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