A Study of Nivolumab in Participants With Hepatocellular Carcinoma Who Are at High Risk of Recurrence After Curative Hepatic Resection or Ablation

NCT03383458 | Active Not Recruiting Phase 3 DMC FDA Drug

• 1 other identifier: CA209-9DX
• Study Type: interventional
• Target: 545
• Locations: 24 countries
• Sites: 177

Brief Summary

This study will investigate if nivolumab will improve recurrence-free survival (RFS) compared to placebo in participants with HCC who have undergone complete resection or have achieved a complete response after local ablation, and who are at high risk of recurrence

Conditions

Hepatocellular Carcinoma; Liver Cancer

Outcome Measures

Primary Outcomes (1)

• Recurrence-free Survival (RFS)

  Up to 49 months

Secondary Outcomes (2)

• Overall Survival (OS)

  Up to 7 years

• Time to recurrence (TTR)

  Up to 49 months

Study Arms (2)

Arm A

EXPERIMENTAL

Biological: Nivolumab

Arm B

PLACEBO COMPARATOR

Other: Placebo

Interventions

Nivolumab BIOLOGICAL

Specified dose on specified days

Also known as: Opdivo, BMS-936558

Arm A

Placebo OTHER

specified dose on specified days

Arm B

Eligibility Criteria

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

You may qualify if:

• Participants with a first diagnosis of HCC who have undergone a curative resection or ablation
• Participants are eligible to enroll if they have non-viral related-HCC, or if they have HBV-HCC, or HCV-HCC
• Child-Pugh Score 5 or 6
• 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
• Any evidence of tumor metastasis or co-existing malignant disease
• Participants previously receiving any prior therapy for HCC, including loco-regional therapies
• Participants who have undergone a liver transplant or those who are in the waiting list for liver transplantation
• Participants who have received a live/attenuated vaccine within 30 days of randomization (eg, varicella, zoster, yellow fever, rotavirus, oral polio and measles, mumps, rubella \[MMR\]).

Sponsors & Collaborators

• Bristol-Myers Squibb: lead
• Ono Pharmaceutical Co. Ltd: collaborator

Study Sites (184)

Local Institution - 0081

Anniston, Alabama, 36207, United States

Location

Mayo Clinic in Arizona - Phoenix

Phoenix, Arizona, 85054, United States

Location

Arizona Oncology Associates, PC - HOPE

Tucson, Arizona, 85711, United States

Location

Local Institution - 0135

Los Angeles, California, 90095, United States

Location

Local Institution - 0088

Palo Alto, California, 94304, United States

Location

Local Institution - 0085

San Francisco, California, 94115, United States

Location

Local Institution - 0235

Aurora, Colorado, 80045, United States

Location

Local Institution - 0267

Miami, Florida, 33125, United States

Location

Sylvester Comprehensive Cancer Center/ UMHC

Miami, Florida, 33136, United States

Location

Local Institution - 0163

Tampa, Florida, 33612, United States

Location

Local Institution - 0009

Atlanta, Georgia, 30322, United States

Location

Local Institution - 0025

Westwood, Kansas, 66205, United States

Location

Local Institution - 0086

New Orleans, Louisiana, 70112, United States

Location

University of Michigan

Ann Arbor, Michigan, 48109, United States

Location

Minnesota Oncology Hematology, P.A.

Minneapolis, Minnesota, 55404, United States

Location

Local Institution - 0209

St Louis, Missouri, 63110, United States

Location

Local Institution - 0075

New York, New York, 10016, United States

Location

Local Institution - 0208

New York, New York, 10029, United States

Location

Local Institution - 0045

New York, New York, 10065, United States

Location

Local Institution - 0219

White Plains, New York, 10601, United States

Location

MetroHealth Medical Center

Cleveland, Ohio, 44109, United States

Location

Local Institution - 0206

Portland, Oregon, 97225, United States

Location

Local Institution - 0272

Austin, Texas, 78705, United States

Location

Local Institution - 0270

Dallas, Texas, 75246, United States

Location

Local Institution - 0156

Dallas, Texas, 75390, United States

Location

Local Institution - 0273

Tyler, Texas, 75702, United States

Location

McGuire VA Medical Center

Richmond, Virginia, 23249, United States

Location

Local Institution - 0154

Seattle, Washington, 98109, United States

Location

Local Institution - 0243

Gorriti, Buenos Aires, 5737, Argentina

Location

Local Institution - 0254

Pilar, Buenos Aires, 1629, Argentina

Location

Local Institution - 0244

Rosario, Santa Fe Province, 2000, Argentina

Location

Local Institution - 0239

Blacktown, New South Wales, 2148, Australia

Location

Local Institution - 0166

Camperdown, New South Wales, 2050, Australia

Location

Local Institution - 0141

Concord, New South Wales, 2139, Australia

Location

Local Institution - 0220

Herston, Queensland, 4029, Australia

Location

Local Institution - 0164

Adelaide, South Australia, 5000, Australia

Location

Local Institution - 0224

Heidelberg, Victoria, 3084, Australia

Location

Local Institution - 0124

Nedlands, Western Australia, 6009, Australia

Location

Local Institution - 0012

Graz, 8036, Austria

Location

Local Institution - 0003

Vienna, 1090, Austria

Location

Local Institution - 0001

Vienna, 1100, Austria

Location

Local Institution - 0033

Brussels, 1070, Belgium

Location

Local Institution - 0064

Brussels, 1200, Belgium

Location

Local Institution - 0068

Edegem, 2650, Belgium

Location

Local Institution - 0071

Ghent, 9000, Belgium

Location

Local Institution - 0108

Leuven, 3000, Belgium

Location

Local Institution - 0090

Belo Horizonte, Minas Gerais, 30130-090, Brazil

Location

Local Institution - 0275

Barretos, São Paulo, 14780-070, Brazil

Location

Local Institution - 0237

Cerqueira César, São Paulo, 01246-000, Brazil

Location

Local Institution

São José do Rio Preto, São Paulo, 15090-000, Brazil

Location

Local Institution

São Paulo, São Paulo, 08270-120, Brazil

Location

Local Institution - 0023

São Paulo, 01308-050, Brazil

Location

Local Institution - 0236

São Paulo, 01509-010, Brazil

Location

Local Institution

Calgary, Alberta, T2N 4Z6, Canada

Location

Local Institution - 0116

Edmonton, T6G 1Z2, Canada

Location

Local Institution - 0247

Viña del Mar, Región de Valparaíso, 2520598, Chile

Location

Local Institution - 0248

Santiago, Santiago Metropolitan, 0, Chile

Location

Local Institution - 0246

Santiago, Santiago Metropolitan, 7710007, Chile

Location

Local Institution - 0245

Santiago, Santiago Metropolitan, 8380420, Chile

Location

Local Institution - 0256

Bogotá, 0, Colombia

Location

Local Institution - 0057

Bobigny, 93000, France

Location

Local Institution - 0052

Brest, 29200, France

Location

CHU Estaing

Clermont-Ferrand, 63003, France

Location

Local Institution - 0046

Clichy, 92110, France

Location

Local Institution - 0061

Créteil, 94010, France

Location

Local Institution - 0013

Grenoble, 38043, France

Location

Local Institution - 0222

Lille, 59037, France

Location

Local Institution - 0051

Lyon, 69317, France

Location

Local Institution - 0043

Montpellier, 34295, France

Location

Local Institution - 0037

Nice, 06202, France

Location

Local Institution

Poitiers, 86021, France

Location

Local Institution - 0098

Reims, 51100, France

Location

Local Institution - 0212

Rennes, 35033, France

Location

Local Institution - 0044

Saint-Priest-en-Jarez, 42270, France

Location

Local Institution - 0011

Vandœuvre-lès-Nancy, 54511, France

Location

Local Institution - 0054

Villejuif, 94800, France

Location

Local Institution - 0024

Aachen, 52057, Germany

Location

Local Institution - 0258

Berlin, 13353, Germany

Location

Local Institution - 0020

Bonn, 53127, Germany

Location

Local Institution - 0050

Cologne, 50937, Germany

Location

Local Institution - 0026

Essen, 45147, Germany

Location

Local Institution - 0093

Frankfurt am Main, 60590, Germany

Location

Local Institution - 0040

Hanover, 30625, Germany

Location

Local Institution - 0019

Homburg, 66421, Germany

Location

Local Institution

Leipzig, 04103, Germany

Location

Local Institution - 0036

Magdeburg, 39104 Magdeburg, Germany

Location

Local Institution - 0048

Mainz, 55131, Germany

Location

Universitatsmedizin Mannheim

Mannheim, 68167, Germany

Location

Local Institution - 0096

München, 81377, Germany

Location

Local Institution - 0008

Tübingen, 72076, Germany

Location

Local Institution

Würzburg, 97078, Germany

Location

Local Institution - 0120

Hong Kong, 999077, Hong Kong

Location

Local Institution - 0076

Hong Kong, Hong Kong

Location

Local Institution - 0136

Messina, ME, 98125, Italy

Location

Local Institution - 0102

Bologna, 40138, Italy

Location

Local Institution - 0077

Florence, 50134, Italy

Location

Local Institution - 0104

Meldola, 47014, Italy

Location

Local Institution - 0091

Milan, 20133, Italy

Location

Local Institution

Modena, 41124, Italy

Location

Local Institution - 0134

Monserrato, 09042, Italy

Location

Local Institution - 0101

Napoli, 80131, Italy

Location

Local Institution - 0119

Napoli, 80131, Italy

Location

Local Institution - 0103

Padua, 35128, Italy

Location

Local Institution - 0125

Rome, 00168, Italy

Location

Local Institution - 0183

Kashiwa-shi, Chiba, 2778577, Japan

Location

Local Institution - 0201

Kurume-shi, Fukuoka, 8300011, Japan

Location

Local Institution - 0200

Sapporo, Hokkaido, 060-8648, Japan

Location

Local Institution - 0184

Sapporo, Hokkaido, 0600033, Japan

Location

Local Institution - 0216

Nishinomiya-shi, Hyōgo, 6638501, Japan

Location

Local Institution - 0257

Morioka, Iwate, 0208505, Japan

Location

Local Institution - 0202

Kumamoto, Kumamoto, 8608556, Japan

Location

Local Institution - 0203

Osaka, Osaka, 5438555, Japan

Location

Local Institution - 0198

Osaka, Osaka, 5458586, Japan

Location

Local Institution

Ōsaka-sayama, Osaka, 5898511, Japan

Location

Local Institution - 0214

Suita-shi, Osaka, 565-0871, Japan

Location

Local Institution - 0185

Tokushima, Tokushima, 770-8503, Japan

Location

Local Institution - 0215

Bunkyo-ku, Tokyo, 1138655, Japan

Location

Local Institution - 0196

Chuo-ku, Tokyo, 1040045, Japan

Location

Local Institution - 0182

Mitaka-shi, Tokyo, 181-8611, Japan

Location

Local Institution - 0210

Musashino-shi, Tokyo, 1808610, Japan

Location

Local Institution - 0186

Shinjuku-ku, Tokyo, 162-8655, Japan

Location

Local Institution - 0187

Chiba, 260-8677, Japan

Location

Local Institution - 0179

Hiroshima, 734-8551, Japan

Location

Local Institution - 0180

Ishikawa, 920-8641, Japan

Location

Local Institution - 0197

Kanagawa, 213-8587, Japan

Location

Local Institution - 0148

Cuauhtémoc, Durango, 06700, Mexico

Location

Local Institution - 0121

Monterrey, Nuevo León, 64000, Mexico

Location

Local Institution - 0264

Monterrey, Nuevo León, 64460, Mexico

Location

Local Institution - 0226

San Luis Potosí City, 78250, Mexico

Location

Local Institution - 0263

Maastricht, 6229 HX, Netherlands

Location

Local Institution - 0260

Utrecht, 3584CX, Netherlands

Location

Local Institution - 0240

Auckland, 1023, New Zealand

Location

Local Institution - 0231

San Juan, 00927, Puerto Rico

Location

Local Institution

Brasov, 500091, Romania

Location

Local Institution - 0078

Bucharest, 022328, Romania

Location

Local Institution - 0232

Cluj-Napoca, 400015, Romania

Location

Local Institution - 0242

Constanța, 900591, Romania

Location

Local Institution - 0074

Craiova, 200542, Romania

Location

Local Institution - 0070

Timișoara, 300166, Romania

Location

Local Institution - 0032

Saint Petersburg, Sankt-Peterburg, 198255, Russia

Location

Arkhangelsk Clinical Oncological Dispensary

Arkhangelsk, 163045, Russia

Location

Local Institution

Leningrad Region, 188663, Russia

Location

Local Institution - 0230

Moscow, 115478, Russia

Location

Local Institution - 0042

Singapore, 119228, Singapore

Location

Local Institution - 0067

Singapore, 169610, Singapore

Location

Local Institution - 0039

Singapore, 308433, Singapore

Location

Local Institution - 0191

Suwon, Gyeonggi-do, 16499, South Korea

Location

Local Institution - 0127

Seoul, Seoul-teukbyeolsi [Seoul], 06351, South Korea

Location

Local Institution - 0177

Daegu, 41944, South Korea

Location

Local Institution - 0190

Goyang-si, 10408, South Korea

Location

Local Institution - 0188

Gyeongsangnam-do, 50612, South Korea

Location

Local Institution - 0178

Jeollanam-do, 58128, South Korea

Location

Local Institution - 0169

Seongnam-si, 13620, South Korea

Location

Local Institution - 0128

Seoul, 03080, South Korea

Location

Local Institution - 0168

Seoul, 03722, South Korea

Location

Local Institution - 0167

Seoul, 05505, South Korea

Location

Local Institution - 0195

Seoul, 06591, South Korea

Location

Local Institution - 0189

Seoul, 08308, South Korea

Location

Local Institution - 0069

Barcelona, 08035, Spain

Location

Local Institution - 0031

Barcelona, 08036, Spain

Location

Local Institution - 0016

Córdoba, 14004, Spain

Location

Local Institution - 0072

Donostia / San Sebastian, 20014, Spain

Location

Local Institution - 0199

Madrid, 28007, Spain

Location

Local Institution - 0109

Madrid, 28046, Spain

Location

Local Institution - 0100

Pamplona, 31008, Spain

Location

Local Institution - 0010

Sabadell (Barcelona), 08208, Spain

Location

Local Institution - 0028

Seville, 41013, Spain

Location

Local Institution - 0082

Valencia, 46026, Spain

Location

Local Institution - 0097

Zaragoza, 50009, Spain

Location

Local Institution - 0131

Tainan, TNN, 704, Taiwan

Location

Local Institution - 0204

Kaohsiung City, 883, Taiwan

Location

Local Institution - 0130

Taichung, 40447, Taiwan

Location

Local Institution - 0140

Taichung, 40705, Taiwan

Location

Local Institution - 0174

Tainan, 736, Taiwan

Location

Local Institution - 0207

Taipei, 100, Taiwan

Location

Local Institution - 0173

Taipei, 105, Taiwan

Location

Local Institution - 0129

Taipei, 11217, Taiwan

Location

Local Institution - 0175

Taoyuan District, 333, Taiwan

Location

Local Institution - 0176

Yunlin, 632, Taiwan

Location

Local Institution - 0111

London, NW3 2QG, United Kingdom

Location

Local Institution - 0092

London, SE5 9RS, United Kingdom

Location

Local Institution - 0153

London, W12 0HS, United Kingdom

Location

Local Institution - 0114

Manchester, M20 4BX, United Kingdom

Location

Local Institution - 0142

Metropolitan Borough of Wirral, CH63 4JY, United Kingdom

Location

Related Links

• BMS Clinical Trial Information
• BMS Clinical Trial Patient Recruiting

MeSH Terms

Conditions

Carcinoma, Hepatocellular; Liver Neoplasms

Interventions

Nivolumab

Condition Hierarchy (Ancestors)

Adenocarcinoma; Carcinoma; Neoplasms, Glandular and Epithelial; Neoplasms by Histologic Type; Neoplasms; Digestive System Neoplasms; Neoplasms by Site; 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

Study Officials

• Bristol-Myers Squibb

  Bristol-Myers Squibb

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR
• Expanded Access: Yes

Study Record Dates

• First Submitted: December 21, 2017
• First Posted: December 26, 2017
• Study Start: April 18, 2018
• Primary Completion: February 27, 2026
• Study Completion (Estimated): February 27, 2031
• Last Updated: November 21, 2025

Record last verified: 2025-11

Locations

KR (12); AU (3); ME (4); NL (2); TW (10); NZ (1); PR (1); ES (11); FR (16); CA (2); JP (21); CL (4); RO (6); GB (5); BE (5); AR (3); BR (7); CO (1); DE (15); US (28); IT (11); HK (2); RU (4); SG (3)