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

Hepatocellular Carcinoma Clinical Trial

— CheckMate 9DX  

Official title:

A Phase 3, Randomized, Double-blind Study of Adjuvant Nivolumab Versus Placebo for Participants With Hepatocellular Carcinoma Who Are at High Risk of Recurrence After Curative Hepatic Resection or Ablation

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT03383458
• Other study ID #: CA209-9DX
• Status: Active, not recruiting
• Phase: Phase 3
• Start date: April 18, 2018
• Est. completion date: December 16, 2025

Study information

• Verified date: November 2023
• Source: Bristol-Myers Squibb
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 545
• Est. completion date: December 16, 2025
• Est. primary completion date: April 28, 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• 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

Exclusion Criteria:

• 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]). Other protocol defined inclusion/exclusion criteria apply

Related Conditions & MeSH terms

• Carcinoma
• Carcinoma, Hepatocellular
• Hepatocellular Carcinoma
• Liver Cancer
• Recurrence

Intervention

Biological:
• Nivolumab
Specified dose on specified days

Other:
• Placebo
specified dose on specified days

Locations

Country	Name	City	State
Argentina	Local Institution - 0243	Gorriti	Buenos Aires
Argentina	Local Institution - 0254	Pilar	Buenos Aires
Argentina	Local Institution - 0244	Rosario	Santa FE
Australia	Local Institution - 0164	Adelaide	South Australia
Australia	Local Institution - 0239	Blacktown	New South Wales
Australia	Local Institution - 0166	Camperdown	New South Wales
Australia	Local Institution - 0141	Concord	New South Wales
Australia	Local Institution - 0224	Heidelberg	Victoria
Australia	Local Institution - 0220	Herston	Queensland
Australia	Local Institution - 0124	Nedlands	Western Australia
Austria	Local Institution - 0012	Graz
Austria	Local Institution - 0001	Vienna
Austria	Local Institution - 0003	Wien
Belgium	Local Institution - 0033	Brussels
Belgium	Local Institution - 0064	Bruxelles
Belgium	Local Institution - 0068	Edegem
Belgium	Local Institution - 0071	Gent
Belgium	Local Institution - 0108	Leuven
Brazil	Local Institution - 0275	Barretos	Sao Paulo
Brazil	Local Institution - 0090	Belo Horizonte	Minas Gerais
Brazil	Local Institution - 0237	Cerqueira Cesar	SAO Paulo
Brazil	Local Institution	Sao Jose Do Rio Preto	Sao Paulo
Brazil	Local Institution - 0023	Sao Paulo
Brazil	Local Institution - 0236	Sao Paulo
Brazil	Local Institution	São Paulo	SAO Paulo
Canada	Local Institution	Calgary	Alberta
Canada	Local Institution - 0116	Edmonton
Chile	Local Institution - 0245	Santiago	Región Metropolitana De Santiago
Chile	Local Institution - 0246	Santiago	Metropolitana
Chile	Local Institution - 0248	Santiago de Chile	Metropolitana
Chile	Local Institution - 0247	Vina del Mar	Valparaiso
Colombia	Local Institution - 0256	Bogota
France	Local Institution - 0057	Bobigny
France	Local Institution - 0052	Brest
France	CHU Estaing	Clermont Ferrand
France	Local Institution - 0046	Clichy
France	Local Institution - 0061	Creteil Cedex
France	Local Institution - 0013	Grenoble Cedex 09
France	Local Institution - 0222	Lille
France	Local Institution - 0051	Lyon Cedex 04
France	Local Institution - 0043	Montpellier Cedex
France	Local Institution - 0037	Nice
France	Local Institution	Poitiers
France	Local Institution - 0098	Reims
France	Local Institution - 0212	Rennes Cedex 9
France	Local Institution - 0044	Saint-Priest-en-Jarez
France	Local Institution - 0011	Vandoeuvre Les Nancy Cedex
France	Local Institution - 0054	Villejuif
Germany	Local Institution - 0024	Aachen
Germany	Local Institution - 0258	Berlin
Germany	Local Institution - 0020	Bonn
Germany	Local Institution - 0026	Essen
Germany	Local Institution - 0093	Frankfurt am Main
Germany	Local Institution - 0040	Hannover
Germany	Local Institution - 0019	Homburg
Germany	Local Institution - 0050	Koln
Germany	Local Institution	Leipzig
Germany	Local Institution - 0036	Magdeburg
Germany	Local Institution - 0048	Mainz
Germany	Universitatsmedizin Mannheim	Mannheim
Germany	Local Institution - 0096	Muenchen
Germany	Local Institution - 0008	Tuebingen
Germany	Local Institution	Wuerzburg
Hong Kong	Local Institution - 0076	Hong Kong
Hong Kong	Local Institution - 0120	Hong Kong
Italy	Local Institution - 0102	Bologna
Italy	Local Institution - 0077	Firenze
Italy	Local Institution - 0104	Meldola
Italy	Local Institution - 0136	Messina	ME
Italy	Local Institution - 0091	Milano
Italy	Local Institution	Modena
Italy	Local Institution - 0134	Monserrato
Italy	Azienda Ospedaliera Specialistica dei Colli Monaldi-Cotugno-CTO	Napoli
Italy	Local Institution - 0119	Napoli
Italy	Local Institution - 0103	Padova
Italy	Fondazione Policlinico Gemelli - Universita Cattolica del Sacro Cuore	Rome
Japan	Local Institution - 0215	Bunkyo-ku	Tokyo
Japan	Local Institution - 0187	Chiba-shi	Chiba
Japan	Local Institution - 0196	Chuo-ku	Tokyo
Japan	Local Institution - 0179	Hiroshima
Japan	Local Institution - 0197	Kanagawa
Japan	Local Institution - 0180	Kanazawa-shi	Ishikawa
Japan	Local Institution - 0183	Kashiwa-shi	Chiba
Japan	Local Institution - 0202	Kumamoto-shi	Kumamoto
Japan	Local Institution - 0201	Kurume-shi	Fukuoka
Japan	Local Institution - 0182	Mitaka-shi	Tokyo
Japan	Local Institution - 0257	Morioka-shi	Iwate
Japan	Local Institution - 0210	Musashino-shi	Tokyo
Japan	Local Institution - 0216	Nishinomiya-shi	Hyogo
Japan	Local Institution	Osaka-sayama	Osaka
Japan	Local Institution - 0198	Osaka-shi	Osaka
Japan	Local Institution - 0203	Osaka-shi	Osaka
Japan	Local Institution - 0184	Sapporo-shi	Hokkaido
Japan	Local Institution - 0200	Sapporo-shi	Hokkaido
Japan	Local Institution - 0186	Shinjuku-ku	Tokyo
Japan	Local Institution - 0214	Suita-shi	Osaka
Japan	Local Institution - 0185	Tokushima-shi	Tokushima
Korea, Republic of	Local Institution - 0177	Daegu
Korea, Republic of	Local Institution - 0190	Goyang-si
Korea, Republic of	Local Institution - 0188	Gyeongsangnam-do
Korea, Republic of	Local Institution - 0178	Jeollanam-do
Korea, Republic of	Local Institution - 0169	Seongnam-si
Korea, Republic of	Local Institution - 0127	Seoul	Seoul-teukbyeolsi [Seoul]
Korea, Republic of	Local Institution - 0128	Seoul
Korea, Republic of	Local Institution - 0167	Seoul
Korea, Republic of	Local Institution - 0168	Seoul
Korea, Republic of	Local Institution - 0189	Seoul
Korea, Republic of	Local Institution - 0195	Seoul
Korea, Republic of	Local Institution - 0191	Suwon-si	Gyeonggi-do
Mexico	Local Institution - 0148	Cuauhtemoc	Durango
Mexico	Local Institution - 0121	Monterrey	Nuevo León
Mexico	Local Institution - 0264	Monterrey	Nuevo Leon
Mexico	Local Institution - 0226	San Luis Potosi
Netherlands	Local Institution - 0263	Maastricht
Netherlands	Local Institution - 0260	Utrecht
New Zealand	Local Institution - 0240	Auckland
Puerto Rico	Local Institution - 0231	San Juan
Romania	Local Institution	Brasov
Romania	Local Institution - 0078	Bucharest
Romania	Local Institution - 0232	Cluj-Napoca
Romania	Local Institution - 0242	Constanta
Romania	Local Institution - 0074	Craiova
Romania	Local Institution - 0070	Timisoara
Russian Federation	Arkhangelsk Clinical Oncological Dispensary	Arkhangelsk
Russian Federation	Local Institution	Leningrad Region
Russian Federation	Local Institution - 0230	Moscow
Russian Federation	Local Institution - 0032	St. Petersburg	Sankt-Peterburg
Singapore	Local Institution - 0039	Singapore
Singapore	Local Institution - 0042	Singapore
Singapore	Local Institution - 0067	Singapore
Spain	Local Institution - 0031	Barcelona
Spain	Local Institution - 0069	Barcelona
Spain	Local Institution - 0016	Córdoba
Spain	Local Institution - 0072	Donostia-San Sebastian
Spain	Local Institution - 0109	Madrid
Spain	Local Institution - 0199	Madrid
Spain	Local Institution - 0100	Pamplona
Spain	Local Institution - 0010	Sabadell (Barcelona)
Spain	Local Institution - 0028	Sevilla
Spain	Local Institution - 0082	Valencia
Spain	Local Institution - 0097	Zaragoza
Taiwan	Local Institution - 0204	Kaohsiung
Taiwan	Local Institution - 0130	Taichung
Taiwan	Local Institution - 0140	Taichung
Taiwan	Local Institution - 0131	Tainan	TNN
Taiwan	Local Institution - 0174	Tainan
Taiwan	Local Institution - 0129	Taipei
Taiwan	Local Institution - 0173	Taipei
Taiwan	Local Institution - 0207	Taipei
Taiwan	Local Institution - 0175	Taoyuan
Taiwan	Local Institution - 0176	Yunlin
United Kingdom	Local Institution - 0092	London
United Kingdom	Local Institution - 0111	London
United Kingdom	Local Institution - 0153	London
United Kingdom	Local Institution - 0114	Manchester
United Kingdom	Local Institution - 0142	Wirral
United States	University of Michigan	Ann Arbor	Michigan
United States	Local Institution - 0081	Anniston	Alabama
United States	Local Institution - 0009	Atlanta	Georgia
United States	Local Institution - 0235	Aurora	Colorado
United States	Local Institution - 0272	Austin	Texas
United States	MetroHealth Medical Center	Cleveland	Ohio
United States	Local Institution - 0156	Dallas	Texas
United States	Texas Oncology Sammons Cancer Center	Dallas	Texas
United States	Local Institution - 0135	Los Angeles	California
United States	Miami VA Healthcare System	Miami	Florida
United States	Sylvester Comprehensive Cancer Center/ UMHC	Miami	Florida
United States	Minnesota Oncology Hematology, P.A.	Minneapolis	Minnesota
United States	Local Institution - 0086	New Orleans	Louisiana
United States	Local Institution - 0075	New York	New York
United States	Local Institution - 0208	New York	New York
United States	Memorial Sloan Kettering Cancer Center	New York	New York
United States	Local Institution - 0088	Palo Alto	California
United States	Mayo Clinic in Arizona - Phoenix	Phoenix	Arizona
United States	Local Institution - 0206	Portland	Oregon
United States	McGuire VA Medical Center	Richmond	Virginia
United States	Local Institution - 0209	Saint Louis	Missouri
United States	Local Institution - 0085	San Francisco	California
United States	Local Institution - 0154	Seattle	Washington
United States	Local Institution - 0163	Tampa	Florida
United States	Arizona Oncology Associates, PC - HOPE	Tucson	Arizona
United States	Local Institution - 0273	Tyler	Texas
United States	Local Institution - 0025	Westwood	Kansas
United States	Local Institution - 0219	White Plains	New York

Sponsors (2)

Lead Sponsor	Collaborator
Bristol-Myers Squibb	Ono Pharmaceutical Co. Ltd

Countries where clinical trial is conducted

United States,  Argentina,  Australia,  Austria,  Belgium,  Brazil,  Canada,  Chile,  Colombia,  France,  Germany,  Hong Kong,  Italy,  Japan,  Korea, Republic of,  Mexico,  Netherlands,  New Zealand,  Puerto Rico,  Romania,  Russian Federation,  Singapore,  Spain,  Taiwan,  United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Recurrence-free Survival (RFS)		Up to 49 months
Secondary	Overall Survival (OS)		Up to 7 years
Secondary	Time to recurrence (TTR)		Up to 49 months

External Links

•   BMS Clinical Trial Information
•   BMS Clinical Trial Patient Recruiting
•   FDA Safety Alerts and Recalls