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PD-L1 Inhibitor

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

Phase 3
Waitlist Available
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
Must not have
Receipt of a small molecule kinase inhibitor (including investigational agents) within 2 weeks before randomization
Receipt of any type of anticancer antibody therapy, systemic chemotherapy, or hormonal anti-cancer therapy within 3 weeks (or bevacizumab within 4 weeks) before randomization
Timeline
Screening 3 weeks
Treatment Varies
Follow Up approximately 26 months after the first subject is randomized.
Awards & highlights

Summary

This trial is testing a combination of two drugs, XL092 and atezolizumab, against another treatment in patients with a specific type of colorectal cancer that has spread and not responded to standard treatments. The goal is to see if the new combination can better stop cancer growth and help the immune system fight the cancer.

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.
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.
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.

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.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:
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I haven't taken any cancer-targeting pill treatments in the last 2 weeks.
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I haven't had cancer treatments like chemotherapy or hormone therapy in the last 3 weeks.
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I have not had major surgery in the last 4 weeks.
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I haven't taken high-dose steroids or immunosuppressants in the last 14 days.
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I haven't had radiation for bone metastasis in the last 2 weeks or any other radiation in the last 4 weeks.
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I have a serious illness that is not under control.
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I have previously been treated with XL092, regorafenib, trifluridine/tipiracil, or drugs targeting PD-L1/PD-1.
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I cannot swallow pills or receive IV treatments, or I have a stomach condition affecting drug absorption.

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

Study objectives can provide a clearer picture of what you can expect from a treatment.
Secondary study objectives
Overall Survival
Other study objectives
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

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
~5850

Research Highlights

Information in this section is not a recommendation. We encourage patients to speak with their healthcare team when evaluating any treatment decision.
Mechanism Of Action
Side Effect Profile
Prior Approvals
Other Research
Colorectal cancer treatments often target specific pathways to inhibit tumor growth and spread. Atezolizumab, a PD-L1 inhibitor, works by blocking the interaction between PD-L1 on tumor cells and PD-1 on immune cells, thereby enhancing the immune system's ability to attack cancer cells. Regorafenib, a multi-kinase inhibitor, targets multiple protein kinases involved in tumor angiogenesis, oncogenesis, and the tumor microenvironment, effectively inhibiting tumor growth and metastasis. These mechanisms are crucial for colorectal cancer patients as they offer targeted approaches to disrupt cancer progression and improve survival outcomes.

Find a Location

Who is running the clinical trial?

ExelixisLead Sponsor
119 Previous Clinical Trials
18,921 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
~231 spots leftby Aug 2025