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

NCT04340193 | Completed Phase 3 Results DMC FDA Drug

• 1 other identifier: CA209-74W
• Study Type: interventional
• Target: 26
• Locations: 18 countries
• Sites: 102

Brief Summary

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.

Conditions

Cancer, Hepatocellular

Outcome Measures

Primary Outcomes (7)

• Number of Participants With Adverse Events

  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.

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

• Number of Participants With Serious Adverse Events (SAEs)

  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.

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

• Number of Participants Who Died

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

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

• Number of Participants With Adverse Events Leading to Study Drug Discontinuation

  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.

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

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

  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.

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

• Number of Participants With Laboratory Abnormalities in Specific Thyroid Tests

  Blood samples were collected for specific thyroid test.

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

• Number of Participants With Clinical Laboratory Abnormalities in Specific Liver Tests

  Blood samples were collected for specific liver tests.

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

Study Arms (3)

Nivolumab + Ipilimumab + TACE

EXPERIMENTAL

TACE (Trans-arterial ChemoEmbolization)

Drug: nivolumab; Drug: ipilimumab; Procedure: TACE

Nivolumab + TACE

EXPERIMENTAL

Drug: nivolumab; Procedure: TACE

TACE

ACTIVE COMPARATOR

Procedure: TACE

Interventions

nivolumab DRUG

Specified dose on specified days

Also known as: Opdivo, BMS-936558

Nivolumab + Ipilimumab + TACE; Nivolumab + TACE

ipilimumab DRUG

Specified dose on specified days

Also known as: Yervoy

Nivolumab + Ipilimumab + TACE

TACE PROCEDURE

TACE (Trans-arterial ChemoEmbolization)

Nivolumab + Ipilimumab + TACE; Nivolumab + TACE; TACE

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Bristol-Myers Squibb: lead

Study Sites (107)

Local Institution - 0189

Coronado, California, 92118, United States

Location

Local Institution

Washington D.C., District of Columbia, 20007, United States

Location

Local Institution - 0005

Louisville, Kentucky, 40202, United States

Location

Local Institution - 0059

Louisville, Kentucky, 40217, United States

Location

Local Institution - 0109

Dallas, Texas, 75203, United States

Location

Local Institution

Wollongong, New South Wales, 2500, Australia

Location

Local Institution - 0037

Birtinya, Queensland, 4575, Australia

Location

Local Institution - 0010

Adelaide, South Australia, 5000, Australia

Location

Local Institution - 0001

Melbourne, Victoria, 3065, Australia

Location

Local Institution - 0139

Murdoch, Western Australia, 6150, Australia

Location

Local Institution - 0026

Graz, 8036, Austria

Location

Local Institution - 0013

Sankt Pölten, 3100, Austria

Location

Local Institution

Vienna, 1100, Austria

Location

Local Institution - 0078

West Springfield, 1090, Austria

Location

Local Institution - 0048

Wiener Neustadt, 2700, Austria

Location

Local Institution - 0020

Brussels, 1200, Belgium

Location

Local Institution

Federal District, 72115700, Belgium

Location

Local Institution - 0053

Ghent, 9000, Belgium

Location

Local Institution - 0050

Plainfield, 1070, Belgium

Location

Local Institution - 0039

Québec, Quebec, G1R 2J6, Canada

Location

Local Institution - 0184

Beijing, Beijing Municipality, 100034, China

Location

Local Institution

Guangzhou, Guangdong, 510060, China

Location

Local Institution

Guangzhou, Guangdong, 510095, China

Location

Local Institution

Tianjin, Hebei, 300060, China

Location

Local Institution - 0196

Nanjing, Jiangsu, 210009, China

Location

Local Institution - 0176

Nanchang, Jiangxi, 330006, China

Location

Local Institution

Shenyang, Liaoning, 110042, China

Location

Local Institution - 0209

Xi'an, Shan3xi, 710100, China

Location

Local Institution - 0151

Shanghai, Shanghai Municipality, 200040, China

Location

Local Institution

Chengdu, Sichuan, 610041, China

Location

Local Institution

Hangzhou, Zhejiang, 310003, China

Location

Local Institution

Hangzhou, Zhejiang, 310022, China

Location

Local Institution - 0055

Olomouc, 779 00, Czechia

Location

Local Institution

Prague, 15000, Czechia

Location

Local Institution - 0014

Lille, Mount, 59037, France

Location

Local Institution - 0132

Caen, 14033, France

Location

Local Institution - 0021

Clichy, 92110, France

Location

Local Institution - 0064

Dijon, 21000, France

Location

Local Institution - 0082

Englewood, 34295, France

Location

Local Institution - 0052

La Tronche, 38700, France

Location

Local Institution - 0061

Marseil, 13285, France

Location

Local Institution - 0087

Nantes, 44093, France

Location

Local Institution - 0012

Nice, 6202, France

Location

Local Institution - 0093

Paris, 75013, France

Location

Local Institution - 0046

Reims, 51092, France

Location

Local Institution - 0094

Villejuif, 94805, France

Location

Local Institution - 0035

Göttingen, 37075, Germany

Location

Local Institution

Hanover, 30625, Germany

Location

Local Institution

Heidelberg, 69120, Germany

Location

Local Institution - 0071

Leipzig, 4103, Germany

Location

Local Institution - 0004

Hong Kong, 0, Hong Kong

Location

Local Institution - 0045

Hong Kong, 0, Hong Kong

Location

Local Institution - 0015

Orbassano, TO, 10043, Italy

Location

Local Institution

Messina, 98124, Italy

Location

Local Institution - 0025

Milan, 20122, Italy

Location

Local Institution

Monserrato, 9042, Italy

Location

Local Institution

Parma, 43126, Italy

Location

Local Institution

Roma, 78584, Italy

Location

Local Institution - 0076

Siena, 53100, Italy

Location

Local Institution - 0070

Vicenza, 36100, Italy

Location

Local Institution - 0108

Chiba, Chiba, 260-8677, Japan

Location

Local Institution - 0122

Matsuyama, Ehime, 790-0024, Japan

Location

Local Institution - 0148

Sapporo, Hokkaido, 060-0033, Japan

Location

Local Institution - 0118

Kanazawa, Ishikawa-ken, 9208641, Japan

Location

Local Institution - 0120

Yokohama, Kanagawa, 2320024, Japan

Location

Local Institution - 0113

Yokohama, Kanagawa, 241-0815, Japan

Location

Local Institution - 0115

Kyoto, Kyoto, 602-0841, Japan

Location

Local Institution - 0127

Abeno-ku, Osaka, 545-8586, Japan

Location

Local Institution - 0125

Izunokuni-Shi, Shizuoka, 4102295, Japan

Location

Local Institution - 0116

Minato-ku, Tokyo, 105-8470, Japan

Location

Local Institution - 0128

Minato-ku, Tokyo, 105-8470, Japan

Location

Local Institution - 0121

Musashino-shi, Tokyo, 180-8610, Japan

Location

Local Institution - 0119

Hiroshima, 734-8551, Japan

Location

Local Institution - 0117

Osaka, 589-8511, Japan

Location

Local Institution - 0123

Saitama, 350-0495, Japan

Location

Local Institution

Warsaw, 02-034, Poland

Location

Local Institution - 0049

San Juan, 00902, Puerto Rico

Location

Local Institution - 0016

Barnaul, 656049, Russia

Location

Local Institution - 0077

Saint Petersburg, 197758, Russia

Location

Local Institution - 0009

Saint Petersburg, 198255, Russia

Location

Local Institution - 0027

Singapore, 119074, Singapore

Location

Local Institution - 0089

Singapore, 217562, Singapore

Location

Local Institution - 0011

Singapore, 308433, Singapore

Location

Local Institution - 0114

Busan, 49241, South Korea

Location

Local Institution - 0135

Daegu, 41944, South Korea

Location

Local Institution - 0047

Gyeongsangnam-do, 050612, South Korea

Location

Local Institution - 0097

Hwasun-Gun, 58128, South Korea

Location

Local Institution - 0161

Seoul, 03080, South Korea

Location

Local Institution - 0186

Seoul, 05505, South Korea

Location

Local Institution - 0160

Seoul, 06351, South Korea

Location

Local Institution - 0164

Seoul, 120-752, South Korea

Location

Local Institution - 0023

Alicante, 03010, Spain

Location

Local Institution - 0092

Córdoba, 14004, Spain

Location

Local Institution - 0101

Madrid, 28007, Spain

Location

Local Institution - 0183

Madrid, 28027, Spain

Location

Local Institution - 0084

Madrid, 28034, Spain

Location

Local Institution - 0018

Madrid, 28041, Spain

Location

Local Institution - 0099

Pamplona, 31008, Spain

Location

Local Institution - 0131

Sabadell, 8208, Spain

Location

Local Institution - 0102

Santiago de Compostela, 15706, Spain

Location

Local Institution - 0136

Buzi, 613, Taiwan

Location

Local Institution - 0141

Kaohsiung City, 807, Taiwan

Location

Local Institution - 0030

Taichung, 40447, Taiwan

Location

Local Institution - 0057

Taichung, 40705, Taiwan

Location

Local Institution - 0029

Tainan, 704, Taiwan

Location

Local Institution - 0002

Taipei, 10002, Taiwan

Location

Local Institution - 0044

Tapei, 11217, Taiwan

Location

Related Links

• BMS Clinical Trial Information
• BMS Clinical Trial Patient Recruiting

MeSH Terms

Conditions

Liver Neoplasms

Interventions

Nivolumab; Ipilimumab

Condition Hierarchy (Ancestors)

Digestive System Neoplasms; Neoplasms by Site; Neoplasms; Digestive System Diseases; Liver Diseases

Intervention Hierarchy (Ancestors)

Antibodies, Monoclonal, Humanized; Antibodies, Monoclonal; Antibodies; Immunoglobulins; Immunoproteins; Blood Proteins; Proteins; Amino Acids, Peptides, and Proteins; Serum Globulins; Globulins

Results Point of Contact

• Title: Bristol-Myers Squibb Study Director
• Organization: Bristol-Myers Squibb

Clinical.Trials@bms.com

Please email

Study Officials

• Bristol-Myers Squibb

  Bristol-Myers Squibb

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR
• Expanded Access: Yes

Study Record Dates

• First Submitted: April 7, 2020
• First Posted: April 9, 2020
• Study Start: September 14, 2020
• Primary Completion: December 12, 2023
• Study Completion: December 12, 2023
• Last Updated: November 26, 2024
• Results First Posted: November 26, 2024

Record last verified: 2024-11

Locations

US (5); CA (1); BE (4); FR (12); CZ (2); IT (8); RU (3); KR (8); ES (9); PR (1); AU (5); CN (12); DE (4); PL (1); HK (2); SG (3); JP (15); TW (7)