Titre A Randomized, Multi-center, Double-blinded, Placebo-controlled Phase 3 Study of Nivolumab and Ipilimumab, Nivolumab Monotherapy, or Placebo in Combination With Trans-arterial ChemoEmbolization (TACE) in Patients With Intermediate-stage Hepatocellular Carcinoma (HCC)
Protocole ID CheckMate 74W
ClinicalTrials.gov ID NCT04340193
Type(s) de cancer Foie
Phase Phase III
Type étude Clinique
Médicament Nivolumab et Ipilimumab, Nivolumab monothérapie ou placebo en association avec TACE
      11 Côte du Palais, Québec, QC, G1R 2J6
Ville Québec
Investigateur(trice) principal(e) Dr Félix Couture
Coordonnateur(trice) Maryse Gingras
Statut Actif en recrutement
Critètes d'éligibilité
  • Participant has intermediate-stage HCC (hepatocellular carcinoma) whose tumor characteristics exceed the BMU7 criteria and is eligible for TACE
  • Participant has histologic confirmation of HCC
  • Eastern Cooperative Oncology Group (ECOG) performance status (PS) 0 or 1
  • Men and Women must agree to follow methods of contraception
  • Participants are eligible to enroll if they have non-viral related HCC, or if they have HBV-HCC, or HCV-HCC
Critètes d'exclusion
  • Known fibrolamellar HCC, sarcomatoid HCC, or mixed cholangiocarcinoma and HCC
  • Prior liver transplant or participants who are on the waiting list for liver transplantation
  • Active, known, or suspected autoimmune disease
  • Participants with a condition requiring systemic treatment with either corticosteroids or other immunosuppressive medications
  • Any previous TACE or TAE (trans-arterial embolization without instillation of chemotherapy agent) procedure for HCC
  • Known or suspected allergy to nivolumab, ipilimumab, or study drug components given in association with this trial
Other protocol defined inclusion/exclusion criteria could apply