Étude de phase 3 du XL092 + Atezolizumab vs Regorafenib chez des sujets atteints d'un cancer colorectal métastatique

Essai clinique

Type : Industriel
Statut : Ouvert
Phase : III
Date d'ouverture : 07/07/2022
Date clôture : 28/02/2026
Promoteur : Exelixis
Progression du cancer: À distance
Résumé :

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.

Domaines/spécialités :
  • Cancers digestifs
    • Colon
    • Rectum
Pathologies :
  • Tumeur maligne du côlon - Cim10 : C18
  • Tumeur maligne du rectum - Cim10 : C20
Liens externes :

Critères de population

Sexe : Homme et femme
Age minimum : 18 ans
Critères d’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.
Critères d’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.

Centres d'investigation

Terminée
Nom : Centre Georges François Leclerc - CGFL
Ville : DIJON (21)
RESPONSABLE MÉDICAL
Aucun responsable médical renseigné
CONTACT TECHNIQUE
Aucun contact technique renseigné
En cours
Nom : CHU de Besançon
Ville : BESANÇON (25)
RESPONSABLE MÉDICAL
Aucun responsable médical renseigné
CONTACT TECHNIQUE
Aucun contact technique renseigné

Référentiels Oncologik

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