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

Cancer, Hepatocellular Clinical Trial

— CheckMate 74W  

Official title:

A Randomized, Multi-center, Double-blinded, Placebo-controlled Phase 3 Study of Nivolumab and Ipilimumab, Nivolumab Monotherapy, or Placebo in Combination With Trans-arterial ChemoEmbolization (TACE) in Patients With Intermediate-stage Hepatocellular Carcinoma (HCC)

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT04340193
• Other study ID #: CA209-74W
• Status: Terminated
• Phase: Phase 3
• Start date: September 15, 2020
• Est. completion date: December 12, 2023

Study information

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

Clinical Trial 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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 26
• Est. completion date: December 12, 2023
• Est. primary completion date: December 12, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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 Other protocol defined inclusion/exclusion criteria apply

Related Conditions & MeSH terms

• Cancer, Hepatocellular
• Liver Neoplasms

Intervention

Drug:
• nivolumab
Specified dose on specified days
• ipilimumab
Specified dose on specified days

Procedure:
• TACE
TACE (Trans-arterial ChemoEmbolization)

Locations

Country	Name	City	State
Australia	Local Institution - 0010	Adelaide	South Australia
Australia	Local Institution - 0037	Birtinya	Queensland
Australia	Local Institution - 0001	Melbourne	Victoria
Australia	Local Institution - 0139	Murdoch	Western Australia
Australia	Local Institution	Wollongong	New South Wales
Austria	Local Institution - 0026	Graz
Austria	Local Institution - 0013	St. Polten
Austria	Local Institution	Vienna
Austria	Local Institution - 0078	West Springfield
Austria	Local Institution - 0048	Wiener Neustadt	Niederosterreich
Belgium	Local Institution - 0020	Brussels
Belgium	Local Institution	Federal District
Belgium	Local Institution - 0053	Gent
Belgium	Local Institution - 0050	Plainfield
Canada	Local Institution - 0039	Quebec
China	Local Institution - 0184	Beijing	Beijing
China	Local Institution	Chengdu	Sichuan
China	Local Institution	Guangzhou	Guangdong
China	Local Institution	Guangzhou	Guangdong
China	Local Institution	Hangzhou	Zhejiang
China	Local Institution	Hangzhou	Zhejiang
China	Local Institution - 0176	Nanchang	Jiangxi
China	Local Institution - 0196	Nanjing	Jiangsu
China	Local Institution - 0151	Shanghai	Shanghai
China	Local Institution	Shenyang	Liaoning
China	Local Institution	Tianjin	Hebei
China	Local Institution - 0209	Xi'an	Shan3xi
Czechia	Local Institution - 0055	Olomouc
Czechia	Local Institution	Praha 5
France	Local Institution - 0132	Caen
France	Local Institution - 0021	Clichy
France	Local Institution - 0064	Dijon
France	Local Institution - 0082	Englewood
France	Local Institution - 0052	La Tronche
France	Local Institution - 0014	Lille	Mount
France	Local Institution - 0061	Marseil
France	Local Institution - 0087	Nantes
France	Local Institution - 0012	Nice
France	Local Institution - 0093	Paris
France	Local Institution - 0046	Reims
France	Local Institution - 0094	Villejuif cedex
Germany	Local Institution - 0035	Goettingen
Germany	Local Institution	Hannover
Germany	Local Institution	Heidelberg
Germany	Local Institution - 0071	Leipzig
Hong Kong	Local Institution - 0045	Hong Kong
Hong Kong	Local Institution - 0004	HongKong
Italy	Local Institution	Messina
Italy	Local Institution - 0025	Milano
Italy	Local Institution	Monserrato
Italy	Local Institution - 0015	Orbassano	TO
Italy	Local Institution	Parma
Italy	Local Institution	Roma
Italy	Local Institution - 0076	Siena
Italy	Local Institution - 0070	Vicenza
Japan	Local Institution - 0127	Abeno-ku	Osaka
Japan	Local Institution - 0108	Chiba
Japan	Local Institution - 0119	Hiroshima
Japan	Local Institution - 0125	Izunokuni-Shi	Shizuoka
Japan	Local Institution - 0118	Kanazawa	Ishikawa
Japan	Local Institution - 0116	Kawasaki	Kanagawa
Japan	Local Institution - 0115	Kyoto-Shi	Kyoto
Japan	Local Institution - 0122	Matsuyama	Ehime
Japan	Local Institution - 0128	Minato-ku	Tokyo
Japan	Local Institution - 0121	Musashino-shi	Tokyo
Japan	Local Institution - 0117	Osaka
Japan	Local Institution - 0123	Saitama
Japan	Local Institution - 0148	Sapporo-shi	Hokkaido
Japan	Local Institution - 0113	Yokohama-Shi	Kanagawa
Japan	Local Institution - 0120	Yokohama-shi	Kanagawa
Korea, Republic of	Local Institution - 0114	Busan
Korea, Republic of	Local Institution - 0135	Daegu
Korea, Republic of	Local Institution - 0047	Gyeongsangnam-do
Korea, Republic of	Local Institution - 0097	Hwasun-Gun
Korea, Republic of	Local Institution - 0160	Seoul
Korea, Republic of	Local Institution - 0161	Seoul
Korea, Republic of	Local Institution - 0164	Seoul
Korea, Republic of	Local Institution - 0186	Seoul
Poland	Local Institution	Warszawa
Puerto Rico	Local Institution - 0049	San Juan
Russian Federation	Local Institution - 0016	Barnaul
Russian Federation	Local Institution - 0077	Saint Petersburg
Russian Federation	Local Institution - 0009	Saint-Petersburg
Singapore	Local Institution	Singapore
Singapore	Local Institution - 0011	Singapore
Singapore	Local Institution - 0089	Singapore
Spain	Local Institution - 0023	Alicante
Spain	Local Institution - 0092	Cordoba
Spain	Local Institution - 0018	Madrid
Spain	Local Institution - 0084	Madrid
Spain	Local Institution - 0101	Madrid
Spain	Local Institution - 0183	Madrid
Spain	Local Institution - 0099	Pamplona
Spain	Local Institution - 0131	Sabadell
Spain	Local Institution - 0102	Santiago de Compostela
Taiwan	Local Institution - 0141	Kaohsiung
Taiwan	Local Institution - 0136	Puzi City
Taiwan	Local Institution - 0057	Taichung
Taiwan	Local Institution - 0030	Taichung City
Taiwan	Local Institution - 0029	Tainan City
Taiwan	Local Institution - 0002	Taipei
Taiwan	Local Institution - 0044	Tapei
United States	Local Institution - 0189	Coronado	California
United States	Local Institution - 0109	Dallas	Texas
United States	Local Institution - 0005	Louisville	Kentucky
United States	Norton Cancer Institute Audubon	Louisville	Kentucky
United States	Local Institution	Washington	District of Columbia

Sponsors (1)

Lead Sponsor	Collaborator
Bristol-Myers Squibb

Countries where clinical trial is conducted

United States,  Australia,  Austria,  Belgium,  Canada,  China,  Czechia,  France,  Germany,  Hong Kong,  Italy,  Japan,  Korea, Republic of,  Poland,  Puerto Rico,  Russian Federation,  Singapore,  Spain,  Taiwan, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Number of treated participants with adverse events (AEs)		Up to 2 years and 4 months
Primary	Number of deaths in all treated patients		Up to 2 years and 4 months
Primary	Number of treated participants with laboratory abnormalities		Up to 2 years and 4 months

External Links

•   BMS Clinical Trial Information
•   BMS Clinical Trial Patient Recruiting