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RecruitingLast updated: 24 May 2024

STELLAR-303: This phase III study is evaluating the effectiveness of a new targeted therapy (XL092) plus immunotherapy (atezolizumab) compared to a different type of targeted therapy (regorafenib) in people with metastatic colorectal cancer (mCRC)A Randomized Open-Label Phase 3 Study of XL092 + Atezolizumab vs Regorafenib in Subjects With Metastatic Colorectal Cancer

Clinical summary

Summary

Eligible participants will be allocated to either the Experimental Arm or the Active Comparator Arm. In the Experimental Arm, participants will receive XL092 (administered orally, daily) plus atezolizumab (administered as a 1200mg IV infusion once in a 3-week cycle). In the Active Comparator Arm, participants will receive regorafenib (administered orally daily at 160mg for the first 21 days of each 28-day cycle).

Conditions

This trial is treating patients with bowel cancer

Cancer

Bowel Cancers Lower gastrointestinal tract

Age

People18+

Phase

III

Trial Acronym

STELLAR-303

More information

Trial Identifiers

Use the hyperlinks, where available to access additional clinical trial information.

Trial sponsor

Exelixis

Scientific Title

A Randomized Open-Label Phase 3 Study of XL092 + Atezolizumab vs Regorafenib in Subjects With Metastatic Colorectal Cancer

Eligibility

Inclusion

  • 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

  • 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.

Inclusion

  • Your cancer has spread to other parts of the body.
  • You have had treatment but your cancer has gotten worse or has not responded to the treatment you have been given.
  • You are able to swallow medication by mouth.
  • You have had a certain type of treatment or surgical procedure.

Exclusion

  • You have certain types of non-cancer medical conditions.
  • You have had certain treatments, surgical procedures or drugs.
Message

Clinical trials have complex eligibility criteria.

Ask your doctor if this trial could be right for you.

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