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Active, Not Recruiting

A Study of Nivolumab and Ipilimumab in Combination With Transarterial ChemoEmbolization (TACE) in Participants With Intermediate Stage Liver Cancer - CA209-74W

Uppdaterad: 14 december, 2023   |   ClinicalTrials.gov

Utskriftsvänlig sammanfattning

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Information om prövningen

  • Phase 3

    Fas

  • Kön

  • 18+

    Åldersintervall

  • Active, Not Recruiting

Behandlingsalternativ

Studiegrupper
TILLDELAD BEHANDLING
Experimental: Nivolumab + Ipilimumab + TACE
Biological: nivolumab, ipilimumab Procedure: TACE
Experimental: Nivolumab + Ipilimumab Placebo + TACE
Procedure: TACE Biological: nivolumab
Placebo Comparator: Nivolumab Placebo + Ipilimumab Placebo + TACE
Procedure: TACE

Viktiga kriterier för deltagandet

For more information regarding Bristol Myers Squibb Clinical Trial participation, please visit www.BMSStudyConnect.com Inclusion Criteria: - 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 Exclusion Criteria: - 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

Vi rekommenderar att du kontaktar BMS för att rapportera biverkningar.
Biverkningar (oönskade händelser) och andra rapporterbara händelser definieras här
För att rapportera biverkningar (oönskade händelser) eller reklamera ett läkemedel: Medicinsk information

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