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

NCT ID: NCT04340193

Last Updated: 2024-11-26

Study Results

Results available

Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.

View full results

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Clinical Phase

PHASE3

Total Enrollment

26 participants

Study Classification

INTERVENTIONAL

Study Start Date

2020-09-14

Study Completion Date

2023-12-12

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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.

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Cancer, Hepatocellular

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

Nivolumab + Ipilimumab + TACE

TACE (Trans-arterial ChemoEmbolization)

Group Type EXPERIMENTAL

nivolumab

Intervention Type DRUG

Specified dose on specified days

ipilimumab

Intervention Type DRUG

Specified dose on specified days

TACE

Intervention Type PROCEDURE

TACE (Trans-arterial ChemoEmbolization)

Nivolumab + TACE

Group Type EXPERIMENTAL

nivolumab

Intervention Type DRUG

Specified dose on specified days

TACE

Intervention Type PROCEDURE

TACE (Trans-arterial ChemoEmbolization)

TACE

Group Type ACTIVE_COMPARATOR

TACE

Intervention Type PROCEDURE

TACE (Trans-arterial ChemoEmbolization)

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

nivolumab

Specified dose on specified days

Intervention Type DRUG

ipilimumab

Specified dose on specified days

Intervention Type DRUG

TACE

TACE (Trans-arterial ChemoEmbolization)

Intervention Type PROCEDURE

Other Intervention Names

Discover alternative or legacy names that may be used to describe the listed interventions across different sources.

Opdivo BMS-936558 Yervoy

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

Bristol-Myers Squibb

INDUSTRY

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Responsibility Role SPONSOR

Principal Investigators

Learn about the lead researchers overseeing the trial and their institutional affiliations.

Bristol-Myers Squibb

Role: STUDY_DIRECTOR

Bristol-Myers Squibb

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

Local Institution - 0189

Coronado, California, United States

Site Status

Local Institution

Washington D.C., District of Columbia, United States

Site Status

Local Institution - 0005

Louisville, Kentucky, United States

Site Status

Local Institution - 0059

Louisville, Kentucky, United States

Site Status

Local Institution - 0109

Dallas, Texas, United States

Site Status

Local Institution

Wollongong, New South Wales, Australia

Site Status

Local Institution - 0037

Birtinya, Queensland, Australia

Site Status

Local Institution - 0010

Adelaide, South Australia, Australia

Site Status

Local Institution - 0001

Melbourne, Victoria, Australia

Site Status

Local Institution - 0139

Murdoch, Western Australia, Australia

Site Status

Local Institution - 0026

Graz, , Austria

Site Status

Local Institution - 0013

Sankt Pölten, , Austria

Site Status

Local Institution

Vienna, , Austria

Site Status

Local Institution - 0078

West Springfield, , Austria

Site Status

Local Institution - 0048

Wiener Neustadt, , Austria

Site Status

Local Institution - 0020

Brussels, , Belgium

Site Status

Local Institution

Federal District, , Belgium

Site Status

Local Institution - 0053

Ghent, , Belgium

Site Status

Local Institution - 0050

Plainfield, , Belgium

Site Status

Local Institution - 0039

Québec, Quebec, Canada

Site Status

Local Institution - 0184

Beijing, Beijing Municipality, China

Site Status

Local Institution

Guangzhou, Guangdong, China

Site Status

Local Institution

Guangzhou, Guangdong, China

Site Status

Local Institution

Tianjin, Hebei, China

Site Status

Local Institution - 0196

Nanjing, Jiangsu, China

Site Status

Local Institution - 0176

Nanchang, Jiangxi, China

Site Status

Local Institution

Shenyang, Liaoning, China

Site Status

Local Institution - 0209

Xi'an, Shan3xi, China

Site Status

Local Institution - 0151

Shanghai, Shanghai Municipality, China

Site Status

Local Institution

Chengdu, Sichuan, China

Site Status

Local Institution

Hangzhou, Zhejiang, China

Site Status

Local Institution

Hangzhou, Zhejiang, China

Site Status

Local Institution - 0055

Olomouc, , Czechia

Site Status

Local Institution

Prague, , Czechia

Site Status

Local Institution - 0014

Lille, Mount, France

Site Status

Local Institution - 0132

Caen, , France

Site Status

Local Institution - 0021

Clichy, , France

Site Status

Local Institution - 0064

Dijon, , France

Site Status

Local Institution - 0082

Englewood, , France

Site Status

Local Institution - 0052

La Tronche, , France

Site Status

Local Institution - 0061

Marseil, , France

Site Status

Local Institution - 0087

Nantes, , France

Site Status

Local Institution - 0012

Nice, , France

Site Status

Local Institution - 0093

Paris, , France

Site Status

Local Institution - 0046

Reims, , France

Site Status

Local Institution - 0094

Villejuif, , France

Site Status

Local Institution - 0035

Göttingen, , Germany

Site Status

Local Institution

Hanover, , Germany

Site Status

Local Institution

Heidelberg, , Germany

Site Status

Local Institution - 0071

Leipzig, , Germany

Site Status

Local Institution - 0004

Hong Kong, , Hong Kong

Site Status

Local Institution - 0045

Hong Kong, , Hong Kong

Site Status

Local Institution - 0015

Orbassano, TO, Italy

Site Status

Local Institution

Messina, , Italy

Site Status

Local Institution - 0025

Milan, , Italy

Site Status

Local Institution

Monserrato, , Italy

Site Status

Local Institution

Parma, , Italy

Site Status

Local Institution

Roma, , Italy

Site Status

Local Institution - 0076

Siena, , Italy

Site Status

Local Institution - 0070

Vicenza, , Italy

Site Status

Local Institution - 0108

Chiba, Chiba, Japan

Site Status

Local Institution - 0122

Matsuyama, Ehime, Japan

Site Status

Local Institution - 0148

Sapporo, Hokkaido, Japan

Site Status

Local Institution - 0118

Kanazawa, Ishikawa-ken, Japan

Site Status

Local Institution - 0120

Yokohama, Kanagawa, Japan

Site Status

Local Institution - 0113

Yokohama, Kanagawa, Japan

Site Status

Local Institution - 0115

Kyoto, Kyoto, Japan

Site Status

Local Institution - 0127

Abeno-ku, Osaka, Japan

Site Status

Local Institution - 0125

Izunokuni-Shi, Shizuoka, Japan

Site Status

Local Institution - 0116

Minato-ku, Tokyo, Japan

Site Status

Local Institution - 0128

Minato-ku, Tokyo, Japan

Site Status

Local Institution - 0121

Musashino-shi, Tokyo, Japan

Site Status

Local Institution - 0119

Hiroshima, , Japan

Site Status

Local Institution - 0117

Osaka, , Japan

Site Status

Local Institution - 0123

Saitama, , Japan

Site Status

Local Institution

Warsaw, , Poland

Site Status

Local Institution - 0049

San Juan, , Puerto Rico

Site Status

Local Institution - 0016

Barnaul, , Russia

Site Status

Local Institution - 0077

Saint Petersburg, , Russia

Site Status

Local Institution - 0009

Saint Petersburg, , Russia

Site Status

Local Institution - 0027

Singapore, , Singapore

Site Status

Local Institution - 0089

Singapore, , Singapore

Site Status

Local Institution - 0011

Singapore, , Singapore

Site Status

Local Institution - 0114

Busan, , South Korea

Site Status

Local Institution - 0135

Daegu, , South Korea

Site Status

Local Institution - 0047

Gyeongsangnam-do, , South Korea

Site Status

Local Institution - 0097

Hwasun-Gun, , South Korea

Site Status

Local Institution - 0161

Seoul, , South Korea

Site Status

Local Institution - 0186

Seoul, , South Korea

Site Status

Local Institution - 0160

Seoul, , South Korea

Site Status

Local Institution - 0164

Seoul, , South Korea

Site Status

Local Institution - 0023

Alicante, , Spain

Site Status

Local Institution - 0092

Córdoba, , Spain

Site Status

Local Institution - 0101

Madrid, , Spain

Site Status

Local Institution - 0183

Madrid, , Spain

Site Status

Local Institution - 0084

Madrid, , Spain

Site Status

Local Institution - 0018

Madrid, , Spain

Site Status

Local Institution - 0099

Pamplona, , Spain

Site Status

Local Institution - 0131

Sabadell, , Spain

Site Status

Local Institution - 0102

Santiago de Compostela, , Spain

Site Status

Local Institution - 0136

Buzi, , Taiwan

Site Status

Local Institution - 0141

Kaohsiung City, , Taiwan

Site Status

Local Institution - 0030

Taichung, , Taiwan

Site Status

Local Institution - 0057

Taichung, , Taiwan

Site Status

Local Institution - 0029

Tainan City, , Taiwan

Site Status

Local Institution - 0002

Taipei, , Taiwan

Site Status

Local Institution - 0044

Tapei, , Taiwan

Site Status

Countries

Review the countries where the study has at least one active or historical site.

United States Australia Austria Belgium Canada China Czechia France Germany Hong Kong Italy Japan Poland Puerto Rico Russia Singapore South Korea Spain Taiwan

Provided Documents

Download supplemental materials such as informed consent forms, study protocols, or participant manuals.

Document Type: Study Protocol and Statistical Analysis Plan

View Document

Related Links

Access external resources that provide additional context or updates about the study.

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

CA209-74W

Identifier Type: -

Identifier Source: org_study_id

More Related Trials

Additional clinical trials that may be relevant based on similarity analysis.