Étude du Magrolimab administré avec FOLFIRI/BEV chez des participants atteints d'un cancer colorectal métastatique avancé inopérable précédemment traité

Essai clinique

Type : Industriel
Statut : Ouvert
Phase : II
Étape du traitement : Traitements combinés
Date d'ouverture : 08/07/2022
Date clôture : 30/11/2026
Promoteur : Gilead Sciences
Progression du cancer: À distance
Résumé :

The primary objectives of this study are: (safety run-in cohort) to evaluate safety and tolerability, and the recommended Phase 2 dose (RP2D) and (randomized cohort) to evaluate the efficacy of magrolimab in combination with bevacizumab and 5-fluorouracil, irinotecan, and leucovorin (FOLFIRI) in previously treated participants with advanced inoperable metastatic colorectal cancer (mCRC).

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 :
  • Previously treated individuals with inoperable metastatic colorectal cancer (mCRC) who are ineligible for checkpoint inhibitor therapy (microsatellite instability (MSI)-H or mismatch repair deficient (dMMR) and are excluded).
  • Histologically or cytologically confirmed adenocarcinoma originating in the colon or rectum (excluding appendiceal and anal canal cancers) who have progressed on or after 1 prior systemic therapy in the setting where curative resection is not indicated. This therapy must have included chemotherapy based on 5-FU with oxaliplatin and either bevacizumab, or for patients with RAS wild-type and left-sided tumors, bevacizumab or cetuximab or panitumumab.
  • Measurable disease (RECIST V1.1 criteria).
  • Individuals must have an eastern cooperative oncology group (ECOG) performance status of 0 or 1.
  • Life expectancy of at least 12 weeks.
  • Laboratory measurements, blood counts: adequate hemoglobin, neutrophil, and platelet counts
  • Adequate liver function.
  • Adequate renal function.
Critères d’exclusion :
  • Prior anticancer therapy including chemotherapy, hormonal therapy, or investigational agents within 3 weeks or within at least 4 half-lives prior to magrolimab dosing (up to a maximum of 4 weeks), whichever is shorter.
  • Known v-raf murine sarcoma viral oncogene homolog B1 (BRAF) V600E or MSI-H mutations or dMMR.
  • Persistent Grade 2 or more gastrointestinal bleeding.
  • Individuals with prior irinotecan therapy.
  • Clinically significant coronary artery disease or myocardial infarction within 6 months prior to inclusion.
  • Peripheral neuropathy of more than Grade 1 (CTCAE Version 5.0).
  • Known dihydropyrimidine dehydrogenase deficiency.
  • Acute intestinal obstruction or subobstruction, history of inflammatory intestinal disease or extended resection of the small intestine. Presence of a colonic prosthesis.
  • Unhealed wound, active gastric or duodenal ulcer, or bone fracture.
  • History of abdominal fistulas, trachea-oesophageal fistulas, any other Grade 4 gastrointestinal perforations, nongastrointestinal fistulas, or intra-abdominal abscesses 6 months prior to screening.
  • Uncontrolled arterial hypertension.
  • Thromboembolic event in the 6 months before inclusion (eg, transitory ischemic stroke, stroke, subarachnoid hemorrhage) except peripheral deep vein thrombosis treated with anticoagulants.
  • Active central nervous system (CNS) disease. Individuals with asymptomatic and stable, treated CNS lesions (radiation and/or surgery and/or other CNS-directed therapy who have not received corticosteroids for at least 4 weeks) are allowed.
  • Red blood cell (RBC) transfusion dependence, defined as requiring more than 2 units of packed RBC transfusions during the 4-week period prior to screening.
  • History of hemolytic anemia, autoimmune thrombocytopenia, or Evans syndrome in the last 3 months.
  • Known hypersensitivity to any of the study drugs, the metabolites, or formulation excipient.
  • Known inherited or acquired bleeding disorders.
  • Significant disease or medical conditions, as assessed by the investigator and sponsor, that would substantially increase the risk-benefit ratio of participating in the study.
  • Second malignancy, except treated basal cell or localized squamous skin carcinomas, or localized prostate cancer.
  • Uncontrolled pleural effusion.

Centre d'investigation

En cours
Nom : CHU de Besançon
Ville : BESANÇON (25)
RESPONSABLE MÉDICAL
Aucun responsable médical renseigné
CONTACT TECHNIQUE
Nom : BERTHOD
Prénom : Diane
Téléphone : 03 70 63 24 03
Email : dberthod@chu-besancon.fr

Référentiels Oncologik

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