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NCT Number: NCT04340193

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

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.

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Key information

Conditions

Cancer, Hepatocellular Digestive System Diseases Digestive System Neoplasms Liver Diseases Liver Neoplasms Neoplasms Neoplasms by Site

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

Local Institution, Wollongong, New South Wales, Australia

Loading trial locations.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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

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

Other protocol defined inclusion/exclusion criteria apply

Treatment and study plan

Nivolumab

Drug

Specified dose on specified days

Other names: Opdivo, BMS-936558

Ipilimumab

Drug

Specified dose on specified days

Other names: Yervoy

TACE

Procedure

TACE (Trans-arterial ChemoEmbolization)

Primary outcomes

  1. Number of Participants With Adverse Events

    Time frame: From first dose and 30 days after last dose of study therapy (up to approximately 25 months)

    An Adverse Event (AE) is defined as any new untoward medical occurrence or worsening of a preexisting medical condition in a clinical investigation participant administered study treatment and that does not necessarily have a causal relationship with this treatment.

  2. Number of Participants With Serious Adverse Events (SAEs)

    Time frame: From first dose and 30 days after last dose of study therapy (up to approximately 25 months)

    Serious Adverse Event (SAE) is defined as any untoward medical occurrence that, at any dose that results in death, Is life-threatening (defined as an event in which the participant was at risk of death at the time of the event; it does not refer to an event which hypothetically might have caused death if it were more severe) or requires inpatient hospitalization or causes prolongation of existing hospitalization, or results in persistent or significant disability/incapacity or is a congenital anomaly/birth defect or is an important medical event.

  3. Number of Participants Who Died

    Time frame: From first dose and 100 days after last dose of study therapy (up to approximately 27 months)

    Number of participants who died due to any cause are summarized.

  4. Number of Participants With Adverse Events Leading to Study Drug Discontinuation

    Time frame: From first dose and 30 days after last dose of study therapy (up to approximately 25 months)

    An Adverse Event (AE) is defined as any new untoward medical occurrence or worsening of a preexisting medical condition in a clinical investigation participant administered study treatment and that does not necessarily have a causal relationship with this treatment.

  5. Number of Participants With Worst Grade (Grade 3/4) Laboratory Results

    Time frame: From first dose and 30 days after last dose of study therapy (up to approximately 25 months)

    Laboratory results were graded using the Common Terminology Criteria for Adverse Events (CTCAE) version 5.0 (Grade 3 =Severe, Grade 4 = Life-threatening). Highest grade measured for hemoglobin and albumin was Grade 3.

  6. Number of Participants With Laboratory Abnormalities in Specific Thyroid Tests

    Time frame: From first dose and 30 days after last dose of study therapy (up to approximately 25 months)

    Blood samples were collected for specific thyroid test.

  7. Number of Participants With Clinical Laboratory Abnormalities in Specific Liver Tests

    Time frame: From first dose and 30 days after last dose of study therapy (up to approximately 25 months)

    Blood samples were collected for specific liver tests.

Sponsors and collaborators

Lead sponsor

Bristol-Myers Squibb

Industry

Registry information

Official study title

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)

Acronym: CheckMate 74W

Important dates

Study start
2020
Primary completion
2023
Study completion
2023
First posted
Apr 9, 2020
Registry last updated
Nov 26, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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