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NCT04340193CompletedPhase 3

A Study of Nivolumab and Ipilimumab and Nivolumab Alone in Combination With Trans-arterial ChemoEmbolization (TACE) in Participants With Intermediate Stage Liver Cancer

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)

Source: ClinicalTrials.gov · Last updated 26 Nov 2024

Brief summary (registry, in English)

The purpose of this study is to evaluate the safety and tolerability of nivolumab with and without ipilimumab in combination with Trans-arterial ChemoEmbolization (TACE) to TACE alone in participants with intermediate liver cancer.

Status (registry)
Completed
Phase (registry)
Phase 3
Study type
Interventional
Enrollment
26 (actual)
First submitted
7 Apr 2020
Start date
14 Sept 2020
Primary completion date
12 Dec 2023
Lead sponsor
Bristol-Myers Squibb
NCT number
NCT04340193

What you commit to

  • Study type: Interventional · Phase 3
  • Participants enrolled: 26
  • From 14 Sept 2020 to the primary completion date, 12 Dec 2023
  • 105 sites in 19 countries
  • Visits and tests: ask the trial team, the registry does not list them

Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.

Who cannot take part

Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.

Prior treatment

  • Prior liver transplant or participants who are on the waiting list for liver transplantation

Other illness

  • Active, known, or suspected autoimmune disease
    • Other protocol defined inclusion/exclusion criteria apply

Other

  • Known fibrolamellar HCC, sarcomatoid HCC, or mixed cholangiocarcinoma and HCC

Who the study is looking for

  • Participant has intermediate-stage hepatocellular carcinoma (HCC) whose tumor characteristics exceed the Beyond Milan and Up-to-7 (BMU7) criteria and is eligible for trans-arterial ChemoEmbolization (TACE)
  • Participant has no extrahepatic spreading (EHS), no regional lymph node involvement, no main, left main, or right main portal vein thrombosis, and no macrovascular invasion (MVI)
  • Eastern Cooperative Oncology Group (ECOG) performance status (PS) 0 or 1

Age in the registry: 18 years to - · Sex: All · Does not accept healthy volunteers

Full criteria on ClinicalTrials.gov

Sites (105)

Sites in registry order. Pick your city on the disease page to sort them by distance.

SiteCityCountrySite status
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GrazAustriaUnknown status
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Sankt PöltenAustriaUnknown status
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ViennaAustriaUnknown status
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West SpringfieldAustriaUnknown status
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Wiener NeustadtAustriaUnknown status
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AdelaideAustraliaUnknown status
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BirtinyaAustraliaUnknown status
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MelbourneAustraliaUnknown status
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MurdochAustraliaUnknown status
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WollongongAustraliaUnknown status
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BrusselsBelgiumUnknown status
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Federal DistrictBelgiumUnknown status
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GhentBelgiumUnknown status
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PlainfieldBelgiumUnknown status
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QuébecCanadaUnknown status
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BeijingChinaUnknown status
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ChengduChinaUnknown status
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GuangzhouChinaUnknown status
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HangzhouChinaUnknown status
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NanchangChinaUnknown status
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NanjingChinaUnknown status
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ShanghaiChinaUnknown status
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ShenyangChinaUnknown status
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TianjinChinaUnknown status
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Xi'anChinaUnknown status
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OlomoucCzechiaUnknown status
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PragueCzechiaUnknown status
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GöttingenGermanyUnknown status
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HanoverGermanyUnknown status
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HeidelbergGermanyUnknown status
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LeipzigGermanyUnknown status
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AlicanteSpainUnknown status
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CórdobaSpainUnknown status
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MadridSpainUnknown status
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MadridSpainUnknown status
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MadridSpainUnknown status
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MadridSpainUnknown status
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PamplonaSpainUnknown status
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SabadellSpainUnknown status
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Santiago de CompostelaSpainUnknown status
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CaenFranceUnknown status
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ClichyFranceUnknown status
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DijonFranceUnknown status
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EnglewoodFranceUnknown status
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La TroncheFranceUnknown status
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LilleFranceUnknown status
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MarseilFranceUnknown status
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NantesFranceUnknown status
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NiceFranceUnknown status
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ParisFranceUnknown status
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ReimsFranceUnknown status
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VillejuifFranceUnknown status
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Hong KongHong Kong SAR ChinaUnknown status
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Hong KongHong Kong SAR ChinaUnknown status
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MessinaItalyUnknown status
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MilanItalyUnknown status
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MonserratoItalyUnknown status
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OrbassanoItalyUnknown status
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ParmaItalyUnknown status
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RomaItalyUnknown status
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SienaItalyUnknown status
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VicenzaItalyUnknown status
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Abeno-kuJapanUnknown status
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ChibaJapanUnknown status
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HiroshimaJapanUnknown status
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Izunokuni-ShiJapanUnknown status
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KanazawaJapanUnknown status
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KyotoJapanUnknown status
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MatsuyamaJapanUnknown status
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Minato-kuJapanUnknown status
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Minato-kuJapanUnknown status
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Musashino-shiJapanUnknown status
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OsakaJapanUnknown status
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SaitamaJapanUnknown status
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SapporoJapanUnknown status
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YokohamaJapanUnknown status
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YokohamaJapanUnknown status
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BusanSouth KoreaUnknown status
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DaeguSouth KoreaUnknown status
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Gyeongsangnam-doSouth KoreaUnknown status
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Hwasun-GunSouth KoreaUnknown status
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SeoulSouth KoreaUnknown status
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SeoulSouth KoreaUnknown status
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SeoulSouth KoreaUnknown status
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SeoulSouth KoreaUnknown status
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WarsawPolandUnknown status
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San JuanPuerto RicoUnknown status
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BarnaulRussiaUnknown status
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Saint PetersburgRussiaUnknown status
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Saint PetersburgRussiaUnknown status
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SingaporeSingaporeUnknown status
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SingaporeSingaporeUnknown status
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SingaporeSingaporeUnknown status
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BuziTaiwanUnknown status
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Kaohsiung CityTaiwanUnknown status
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TaichungTaiwanUnknown status
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TaichungTaiwanUnknown status
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TainanTaiwanUnknown status
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TaipeiTaiwanUnknown status
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TapeiTaiwanUnknown status
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CoronadoUnited StatesUnknown status
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DallasUnited StatesUnknown status
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LouisvilleUnited StatesUnknown status
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LouisvilleUnited StatesUnknown status
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Washington D.C.United StatesUnknown status

This page is information, not medical advice. Discuss any trial with your doctor.