A study of nivolumab and ipilimumab in combination with Transarterial ChemoEmbolization (TACE) in participants with intermediate stage liver cancer (CheckMate 74W)

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) - CheckMate 74W: CHECKpoint pathway and nivoluMAb clinical Trial Evaluation 74W

Status

Active, not recruiting

Phases

Phase 3

Study type

Interventional

Source

EU CTR

Registry ID

EUCTR2019-002790-58-AT

Enrollment

Registered

2020-06-02

Start date

2020-09-24

Completion date

Unknown

Last updated

2024-03-12

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Intermediate-stage Hepatocellular Carcinoma (HCC) MedDRA version: 21.1 Level: LLT Classification code 10049010 Term: Carcinoma hepatocellular System Organ Class: 100000004864

Interventions

Trade Name: Opdivo (100 mg/10 ml) Product Name: NIVOLUMAB - 10mL vial (COMMERCIAL) Product Code: BMS-936558 Pharmaceutical Form: Concentrate for solution for infusion INN or Proposed INN: NIVOLUMAB CA

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: a) Participant has intermediate-stage HCC (hepatocellular carcinoma) whose tumor characteristics exceed the BMU7 criteria and is eligible for TACE b) Participant has histologic confirmation of HCC c) Eastern Cooperative Oncology Group (ECOG) performance status (PS) 0 or 1 d) Men and Women must agree to follow methods of contraception e) Participants are eligible to enroll if they have non-viral related HCC, or if they have HBV-HCC, or HCV-HCC Other protocol defined inclusion/exclusion criteria could apply. Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range 10 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range 16

Exclusion criteria

Exclusion criteria: a) Known fibrolamellar HCC, sarcomatoid HCC, or mixed cholangiocarcinoma and HCC b) Prior liver transplant or participants who are on the waiting list for liver transplantation c) Active, known, or suspected autoimmune disease d) Participants with a condition requiring systemic treatment with either corticosteroids or other immunosuppressive medications e) Any previous TACE or TAE (trans-arterial embolization without instillation of chemotherapy agent) procedure for HCC f) 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

Design outcomes

Primary

Measure	Time frame
Main Objective: To evaluate the safety and tolerability of Arm A, Arm B, and Arm C in all treated participants;Secondary Objective: None;Primary end point(s): Incidence of adverse events (AEs), serious adverse event (SAEs), deaths, AEs leading to treatment discontinuation, and laboratory abnormalities in all treated participants.;Timepoint(s) of evaluation of this end point: As specified in the protocol.	—

Measure

Time frame

Main Objective: To evaluate the safety and tolerability of Arm A, Arm B, and Arm C in all treated participants;Secondary Objective: None;Primary end point(s): Incidence of adverse events (AEs), serious adverse event (SAEs), deaths, AEs leading to treatment discontinuation, and laboratory abnormalities in all treated participants.;Timepoint(s) of evaluation of this end point: As specified in the protocol.

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Secondary

Measure	Time frame
Secondary end point(s): None;Timepoint(s) of evaluation of this end point: None	—

Countries

Argentina, Australia, Austria, Belarus, Belgium, Brazil, Canada, China, Czechia, Czech Republic, France, Germany, Hong Kong, Italy, Japan, Korea, Republic of, Poland, Puerto Rico, Russian Federation, Singapore, Spain, Switzerland, Taiwan, United States

Contacts

Public ContactGCT-SU

Bristol-Myers Squibb International Corporation

clinical.trials@bms.com

Outcome results

None listed

Source: EU CTR (via WHO ICTRP) · Data processed: Feb 4, 2026