A Study of Nivolumab in Combination With Ipilimumab in Participants With Advanced Hepatocellular Carcinoma

Hepatocellular Carcinoma Clinical Trial

— CheckMate 9DW  

Official title:

A Randomized, Multi-center, Phase 3 Study of Nivolumab in Combination With Ipilimumab Compared to Sorafenib or Lenvatinib as First-Line Treatment in Participants With Advanced Hepatocellular Carcinoma

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT04039607
• Other study ID #: CA209-9DW
• Status: Active, not recruiting
• Phase: Phase 3
• Start date: September 30, 2019
• Est. completion date: September 30, 2026

Study information

• Verified date: May 2024
• Source: Bristol-Myers Squibb
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

The main purpose of this study is to compare the overall survival (OS) of nivolumab plus ipilimumab versus standard of care (SOC) (sorafenib or lenvatinib) in all randomized participants with advanced hepatocellular carcinoma (HCC) who have not received prior systemic therapy.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 732
• Est. completion date: September 30, 2026
• Est. primary completion date: September 30, 2026
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Participants must have a diagnosis of HCC based on histological confirmation

• Participants must have an advanced HCC

• Participants must have at least one Response Evaluation Criteria in Solid Tumors (RECIST) 1.1 measurable previously untreated lesion

• 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

• Prior liver transplant

• Episodes of hepatic encephalopathy (greater than or equal to [>=] Grade 2) within 12 months prior to randomization

• Active brain metastases or leptomeningeal metastases

Other protocol-defined inclusion/exclusion criteria apply.

Related Conditions & MeSH terms

• Carcinoma
• Carcinoma, Hepatocellular
• Hepatocellular Carcinoma

Intervention

Drug:
• Nivolumab
Participants will receive nivolumab as intravenous (IV) infusion.
• Ipilimumab
Participants will receive ipilimumab as IV infusion.
• Sorafenib
Participants will receive sorafenib as oral tablets.
• lenvatinib
Participants will receive lenvatinib as oral capsules.

Locations

Country	Name	City	State
Argentina	Local Institution - 0136	Buenos Aires
Argentina	Local Institution - 0037	Caba	Buenos Aires
Argentina	Local Institution - 0194	Pilar Provincia De Buenos Aires	Buenos Aires
Argentina	Local Institution - 0282	Rosario	Santa Fe
Argentina	Local Institution - 0058	Tucuman
Australia	Local Institution - 0009	Adelaide	South Australia
Australia	Local Institution - 0004	Birtinya	Queensland
Australia	Local Institution - 0019	Clayton	Victoria
Australia	Local Institution - 0026	Fitzroy	Victoria
Australia	Local Institution - 0013	Herston	Queensland
Australia	Local Institution - 0003	Kogarah	New South Wales
Australia	Local Institution - 0038	Liverpool	New South Wales
Australia	Local Institution - 0001	Melbourne	Victoria
Australia	Local Institution - 0020	St Albans	Victoria
Australia	Local Institution - 0002	Westmead	New South Wales
Austria	Local Institution - 0188	Graz
Austria	Local Institution - 0065	Klagenfurt
Austria	Local Institution - 0114	St. Polten	Niederosterreich
Austria	Local Institution - 0186	Viena
Austria	Local Institution - 0057	Wiener Neustadt	Niederosterreich
Belgium	Local Institution - 0034	Brussels
Belgium	Local Institution - 0008	Federal District
Belgium	Local Institution - 0124	Gent
Belgium	Local Institution - 0298	Gent
Belgium	Local Institution - 0099	Haine-Saint-Paul
Belgium	Local Institution - 0064	Leuven
Belgium	Local Institution - 0104	Liege
Brazil	Local Institution - 0181	Brasilia	DF
Brazil	Local Institution - 0279	Ijui	Rio Grande Do Sul
Brazil	Local Institution - 0054	Jau	SAO Paulo
Brazil	Local Institution - 0016	Parana
Brazil	Local Institution - 0060	Pelotas	RIO Grande DO SUL
Brazil	Local Institution - 0015	Rio de Janeiro
Brazil	Local Institution	Salvador	Bahia
Brazil	Local Institution - 0061	Salvador	Bahia
Brazil	Local Institution - 0280	Sao Jose do Rio Preto	Sao Paulo
Brazil	Local Institution - 0022	Sao Paulo
Brazil	Local Institution - 0023	Sao Paulo
Brazil	Local Institution - 0050	Sao Paulo
Brazil	Local Institution - 0278	Vitoria	Espirito Santo
Canada	Local Institution - 0192	Edmonton	Alberta
Chile	Local Institution - 0094	La Serena	Coquimbo
Chile	Local Institution - 0024	Santiago	Metropolitana
Chile	Local Institution - 0156	Santiago	Metropolitana
Chile	Local Institution - 0283	Santiago	RM
Chile	Local Institution - 0095	Santiago de Chile	Metropolitana
Chile	Local Institution - 0296	Temuco	Araucania
Chile	Local Institution - 0012	Vina del Mar	Valparaiso
Chile	Local Institution - 0216	Vina del Mar	Valparaiso
China	Local Institution - 0152	Beijing	Beijing
China	Local Institution - 0175	Beijing	Beijing
China	Local Institution - 0162	Changchun	Jilin
China	Local Institution - 0166	Changchun	Jilin
China	Local Institution - 0059	Changsha	Hunan
China	Local Institution - 0109	Changsha	Hunan
China	Local Institution - 0179	Chongqing	Sichuan
China	Local Institution - 0131	Dalian	Liaoning
China	Local Institution - 0151	Fuzhou	Fujian
China	Local Institution - 0121	Fuzhou City	Fujian
China	Local Institution - 0125	Guangzhou	Guangdong
China	Local Institution - 0150	Guangzhou	Guangdong
China	Local Institution - 0107	Hangzhou	Zhejiang
China	Local Institution - 0108	Hangzhou	Zhejiang
China	Local Institution - 0135	Harbin	Heilongjiang
China	Local Institution - 0146	Hefei	Anhui
China	Local Institution - 0120	Hefei Shi	Anhui
China	Local Institution - 0145	Nanchang	Jiangxi
China	Local Institution - 0149	Nanchang	Jiangxi
China	Local Institution - 0130	Nanjing	Jiangsu
China	Local Institution - 0153	Qingdao	Shandong
China	Local Institution - 0134	Shanghai	Shanghai
China	Local Institution - 0123	Shenyang	Liaoning
China	Local Institution - 0132	Shenyang	Liaoning
China	Local Institution - 0307	Xi'an	Shan3xi
China	Local Institution - 0133	Xian	Shan3xi
China	Local Institution - 0147	Xian	Shan3xi
Czechia	Local Institution	Brno
Czechia	Local Institution - 0274	Praha	Prague
France	Local Institution - 0068	Amiens
France	Local Institution - 0116	Caen
France	Local Institution - 0069	Clichy
France	Local Institution - 0138	Dijon
France	Local Institution - 0081	Grenoble Cedex 9
France	Local Institution - 0070	Lyon
France	Local Institution	Marseille
France	Local Institution - 0082	Montpellier
France	Local Institution - 0067	Nice
France	Local Institution - 0025	Pessac
France	Local Institution - 0137	Poitiers
France	Local Institution - 0042	Toulouse Cedex 9
France	Local Institution - 0071	Vandoeuvre les Nancy
France	Local Institution - 0051	Villejuif
Germany	Local Institution - 0231	Bonn
Germany	Local Institution - 0052	Essen
Germany	Local Institution - 0005	Frankfurt	Hessen
Germany	Local Institution - 0185	Freiburg
Germany	Local Institution - 0006	Hamburg
Germany	Local Institution - 0102	Hannover
Germany	Local Institution - 0028	Koeln
Germany	Local Institution - 0118	Leipzig
Germany	Local Institution - 0031	Mainz
Germany	Local Institution - 0056	Mannheim
Germany	Local Institution	Munchen
Germany	Local Institution - 0053	North Rhine-Westphalia
Hong Kong	Local Institution - 0032	Hong Kong
Hong Kong	Local Institution - 0036	Hong Kong
Italy	Local Institution - 0084	Candiolo
Italy	Local Institution - 0110	Meldola	Forli-Cesena
Italy	Local Institution - 0039	Milano
Italy	Local Institution - 0100	Novara
Italy	Local Institution - 0219	Padova
Italy	Local Institution - 0033	Parma
Italy	Local Institution - 0112	Roma
Italy	Local Institution - 0079	Rome
Italy	Local Institution - 0101	Rozzano	Milano
Italy	Local Institution - 0111	Siena
Italy	Local Institution - 0044	Vicenza
Japan	Local Institution - 0263	Abeno-ku	Osaka
Japan	Local Institution - 0204	Chiba
Japan	Local Institution - 0178	Fukuoka
Japan	Local Institution - 0177	Hiroshima
Japan	Local Institution - 0258	Iruma-gun	Saitama
Japan	Local Institution - 0259	Izunokuni-shi	Shizuoka
Japan	Local Institution - 0176	Kanazawa	Ishikawa
Japan	Local Institution - 0261	Kashihara City	Nara
Japan	Local Institution - 0193	Kashiwa-shi	Chiba
Japan	Local Institution - 0189	Kyoto-shi	Kyoto
Japan	Local Institution - 0203	Matsuyama	Ehime
Japan	Local Institution - 0128	Minato	Tokyo
Japan	Local Institution - 0122	Minato-ku	Tokyo
Japan	Local Institution - 0201	Mitaka	Tokyo
Japan	Local Institution - 0199	Musashino-shi	Tokyo
Japan	Local Institution - 0127	Osakasayama	Osaka
Japan	Local Institution - 0281	Saga Shi	Saga
Japan	Local Institution - 0155	Sapporo
Japan	Local Institution - 0200	Yokohama-Shi	Kanagawa
Japan	Local Institution - 0262	Yokohama-shi	Kanagawa
Korea, Republic of	Local Institution - 0142	Busan
Korea, Republic of	Local Institution - 0167	Guro-gu	Seoul
Korea, Republic of	Local Institution - 0097	Gyeonggi-do
Korea, Republic of	Local Institution - 0098	Gyeongsangnam-do
Korea, Republic of	Local Institution - 0062	Jongno-gu	Seoul
Korea, Republic of	Local Institution - 0143	Seongnam	Gyeonggi-do
Korea, Republic of	Local Institution - 0139	Seoul
Korea, Republic of	Local Institution - 0140	Seoul
Korea, Republic of	Local Institution - 0141	Seoul
New Zealand	Local Institution - 0047	Auckland
New Zealand	Local Institution - 0286	Christchurch	Canterbury
Poland	Local Institution - 0148	Gdansk
Poland	Local Institution - 0049	Otwock
Poland	Local Institution - 0092	Warszawa
Puerto Rico	Local Institution - 0289	Rio Piedras
Puerto Rico	Local Institution - 0035	San Juan
Romania	Local Institution - 0164	Bucharest
Romania	Local Institution - 0165	Cluj Napoca
Romania	Local Institution	Craiova
Romania	Local Institution - 0103	Craiova	Dolj
Romania	Local Institution - 0163	Timisoara
Russian Federation	Local Institution - 0029	Arkhangelsk
Russian Federation	Local Institution - 0066	Barnaul
Russian Federation	Local Institution - 0074	Chelyabinsk
Russian Federation	Local Institution - 0007	Moscow
Russian Federation	Local Institution - 0072	Pyatigorsk
Russian Federation	Local Institution - 0075	Saint-Petersburg
Russian Federation	Local Institution - 0091	Saint-Petersburg
Russian Federation	Local Institution - 0073	Sochi
Singapore	Local Institution - 0017	Singapore
Singapore	Local Institution - 0048	Singapore
Singapore	Local Institution - 0174	Singapore
Spain	Local Institution - 0055	Barcelona
Spain	Local Institution - 0089	Barcelona
Spain	Local Institution - 0297	Barcelona
Spain	Local Institution - 0090	Cordoba
Spain	Local Institution - 0087	El Palmar
Spain	Local Institution - 0041	Madrid
Spain	Local Institution - 0093	Madrid
Spain	Local Institution - 0290	Madrid
Spain	Local Institution - 0045	Majadahonda
Spain	Local Institution - 0085	Pamplona
Spain	Local Institution - 0088	Santander
Spain	Local Institution - 0040	Zaragoza
Switzerland	Local Institution - 0063	Bern
Taiwan	Local Institution - 0096	Kaohsiung
Taiwan	Local Institution - 0272	Kaohsiung
Taiwan	Local Institution - 0105	Taichung
Taiwan	Local Institution - 0271	Taichung
Taiwan	Local Institution - 0168	Tainan
Taiwan	Local Institution - 0270	Tainan
Taiwan	Local Institution - 0078	Taipei
Taiwan	Local Institution - 0144	Taipei
Taiwan	Local Institution - 0173	Taoyuan
United Kingdom	Local Institution - 0160	Edinburgh
United Kingdom	Local Institution - 0154	Guildford	Surrey
United Kingdom	Local Institution - 0129	London
United Kingdom	Local Institution - 0171	London	Greater London
United States	Local Institution	Ann Arbor	Michigan
United States	Local Institution - 0190	Baltimore	Maryland
United States	Local Institution - 0288	Coronado	California
United States	Local Institution - 0304	Dallas	Texas
United States	Local Institution - 0018	Detroit	Michigan
United States	Local Institution - 0157	Duarte	California
United States	Local Institution - 0202	Houston	Texas
United States	Local Institution - 0027	Louisville	Kentucky
United States	Local Institution - 0046	Lubbock	Texas
United States	Local Institution - 0295	Newark	New Jersey
United States	Local Institution - 0284	Pittsburgh	Pennsylvania
United States	Local Institution - 0172	Salt Lake City	Utah
United States	Local Institution - 0043	Toledo	Ohio
United States	Local Institution - 0292	Tucson	Arizona
United States	Local Institution - 0077	Washington	District of Columbia

Sponsors (1)

Lead Sponsor	Collaborator
Bristol-Myers Squibb

Countries where clinical trial is conducted

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

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Overall Survival (OS)		Up to 4 years
Secondary	Objective Response Rate (ORR)		Up to 4 years
Secondary	Duration of Response (DOR)		Up to 4 years
Secondary	Time to Symptom Deterioration (TTSD)		Up to 4 years

External Links

•   BMS Clinical Trial Information
•   BMS Clinical Trial Patient Recruiting