Study of XL092 + Atezolizumab vs Regorafenib in Subjects With Metastatic Colorectal Cancer (STELLAR-303)
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|ClinicalTrials.gov Identifier: NCT05425940|
Recruitment Status : Recruiting
First Posted : June 21, 2022
Last Update Posted : May 6, 2023
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|Condition or disease||Intervention/treatment||Phase|
|Colorectal Cancer||Drug: XL092 Drug: Atezolizumab Drug: Regorafenib||Phase 3|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||600 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||None (Open Label)|
|Official Title:||A Randomized Open-Label Phase 3 Study of XL092 + Atezolizumab vs Regorafenib in Subjects With Metastatic Colorectal Cancer|
|Actual Study Start Date :||September 7, 2022|
|Estimated Primary Completion Date :||August 2025|
|Estimated Study Completion Date :||February 2026|
Experimental: Experimental Arm
Subjects with mCRC will receive XL092 + atezolizumab
Supplied as tablets; administered orally daily
Supplied as 1200 mg/20 mL vials; administered as a 1200 mg IV infusion once in a 3-week cycle (q3w)
Other Name: Tecentriq®
Active Comparator: Control Arm
Subjects with mCRC will receive active comparator of regorafenib
Supplied as 40 mg tablets; administered orally daily at 160 mg for the first 21 days of each 28-day cycle
Other Name: Stivarga®
- Duration of Overall Survival (OS) [ Time Frame: Approximately 26 months after the first subject is randomized ]Defined as the time from randomization to death due to any cause
- Duration of Progression-Free Survival (PFS) as assessed by the Investigator per RECIST 1.1 [ Time Frame: Approximately 26 months after the first subject is randomized ]Defined as the time randomization to the earlier of either radiographic progressive disease (PD) as assessed by the Investigator per RECIST 1.1 or death from any cause
- Objective Response Rate (ORR) as assessed by the Investigator per RECIST 1.1 [ Time Frame: Up to 36 months after the first subject is randomized ]Defined as the proportion of subjects experiencing a confirmed complete response (CR) or confirmed partial response (PR) per as assessed by the Investigator RECIST 1.1 criteria
- Duration of Response (DOR) as assessed by the Investigator per RECIST 1.1 [ Time Frame: Up to 36 months after the first subject is randomized ]Defined as the time from the first documentation of objective response (subsequently confirmed at a visit ≥ 28 days later) to disease progression or death due to any cause
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.
|Ages Eligible for Study:||18 Years and older (Adult, Older Adult)|
|Sexes Eligible for Study:||All|
|Accepts Healthy Volunteers:||No|
Subjects with histologically or cytologically confirmed adenocarcinoma of the colon or rectum.
- Documented RAS status (mutant or wild-type [WT]), by tissue-based analysis.
- Documented NOT to have microsatellite instability-high (MSI-high) or mismatch repair deficient (dMMR) CRC by tissue-based analysis.
Has received standard-of-care (SOC) anticancer therapies as prior therapy for metastatic CRC and has radiographically progressed, is refractory or intolerant to these therapies.
- Radiographic progression during treatment with or within 3 months following the last dose of the most recent approved SOC chemotherapy regimen.
- Measurable disease according to RECIST v1.1 as determined by the Investigator.
- Available archival tumor biopsy material. If archival tissue is unavailable, must provide fresh tumor tissue biopsy prior to randomization.
- Recovery to baseline or ≤ Grade 1 severity (CTCAE v5) from adverse events (AEs) related to any prior treatments, unless AE(s) are clinically nonsignificant and/or stable on supportive therapy.
- Age 18 years or older on the day of consent.
- Eastern Cooperative Oncology Group (ECOG) performance status of 0-1.
- Adequate organ and marrow function.
- Prior treatment with XL092, regorafenib, trifluridine/tipiracil, or PD-L1/PD-1 targeting immune checkpoint inhibitors (ICIs).
- 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.
- Radiation therapy for bone metastasis within 2 weeks, any other radiation therapy within 4 weeks before randomization.
- Known brain metastases or cranial epidural disease unless adequately treated with radiotherapy and/or surgery (including radiosurgery) and stable for at least 4 weeks before randomization.
- Concomitant anticoagulation with oral anticoagulants and platelet inhibitors.
- Corrected QT interval calculated by the Fridericia formula (QTcF) > 460 ms within 10 days before randomization.
- Pregnant or lactating females.
- Administration of a live, attenuated vaccine within 30 days before randomization.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT05425940
|Contact: Exelixis Clinical Trials||1-888-EXELIXIS (888-393-5494)||firstname.lastname@example.org|
|Contact: Backup or International||650-837-7400|
|Other Study ID Numbers:||
2021-003243-21 ( EudraCT Number )
|First Posted:||June 21, 2022 Key Record Dates|
|Last Update Posted:||May 6, 2023|
|Last Verified:||May 2023|
|Individual Participant Data (IPD) Sharing Statement:|
|Plan to Share IPD:||No|
|Studies a U.S. FDA-regulated Drug Product:||Yes|
|Studies a U.S. FDA-regulated Device Product:||No|
Digestive System Neoplasms
Neoplasms by Site
Digestive System Diseases
Immune Checkpoint Inhibitors
Molecular Mechanisms of Pharmacological Action
Antineoplastic Agents, Immunological