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Study of XL092 + Atezolizumab vs Regorafenib in Subjects With Metastatic Colorectal Cancer (STELLAR-303)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT05425940
Recruitment Status : Recruiting
First Posted : June 21, 2022
Last Update Posted : May 6, 2023
Sponsor:
Information provided by (Responsible Party):
Exelixis

Study Description
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Brief Summary:
This is a multicenter, randomized, open-label, controlled Phase 3 trial of XL092 + atezolizumab vs regorafenib in subjects with microsatellite stable/microsatellite instability low (MSS/MSI-low) metastatic colorectal cancer (mCRC) who have progressed after or are intolerant to standard-of-care (SOC) therapy.

Condition or disease Intervention/treatment Phase
Colorectal Cancer Drug: XL092 Drug: Atezolizumab Drug: Regorafenib Phase 3

Study Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 600 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
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

Resource links provided by the National Library of Medicine


Arms and Interventions
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Arm Intervention/treatment
Experimental: Experimental Arm
Subjects with mCRC will receive XL092 + atezolizumab
 Drug: XL092
Supplied as tablets; administered orally daily

Drug: Atezolizumab
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
 Drug: 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®


Outcome Measures
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Primary Outcome Measures :
  1. 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


Other Outcome Measures:
  1. 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

  2. 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

  3. 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


Eligibility Criteria
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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • 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.

Exclusion Criteria:

  • 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.
Contacts and Locations
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Information from the National Library of Medicine

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


Contacts
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Contact: Exelixis Clinical Trials 1-888-EXELIXIS (888-393-5494) druginfo@exelixis.com
Contact: Backup or International 650-837-7400

Locations
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Sponsors and Collaborators
Exelixis
More Information
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Responsible Party: Exelixis
ClinicalTrials.gov Identifier: NCT05425940    
Other Study ID Numbers: XL092-303
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

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Exelixis:
Colorectal Cancer
Additional relevant MeSH terms:
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Colorectal Neoplasms
Intestinal Neoplasms
Gastrointestinal Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Neoplasms
Digestive System Diseases
Gastrointestinal Diseases
 Colonic Diseases
Intestinal Diseases
Rectal Diseases
Atezolizumab
Immune Checkpoint Inhibitors
Molecular Mechanisms of Pharmacological Action
Antineoplastic Agents, Immunological
Antineoplastic Agents