Main
/Trials
/NCT05337137

A Study of Nivolumab and Relatlimab in Combination With Bevacizumab in Advanced Liver Cancer

Trial number:
NCT05337137
Trial phase:
1, 2
Study type:
Immunotherapy, Targeted therapy
Overall status:
Recruiting

Study start date

May, 2022

Scientific title

A Phase 1/2, Safety Confirmation, Placebo-controlled, Randomized Study of Nivolumab in Combination With Relatlimab and Bevacizumab in Treatment-naive Advanced/Metastatic Hepatocellular Carcinoma

Summary

The purpose of this study is to evaluate the safety and effectiveness of triplet therapy of nivolumab, relatlimab and bevacizumab versus nivolumab and bevacizumab in participants with untreated advanced/metastatic hepatocellular carcinoma (HCC).

Histologically confirmed advanced/metastatic hepatocellular carcinoma (HCC)Naïve to systemic therapy for advanced/metastatic HCC (prior neo-adjuvant or adjuvant immunotherapy is permitted if recurrence occurs ≥ 6 months after treatment completion and the case is discussed with BMS medical team) Child-Pugh score of 5 or 6 (ie, Child-Pugh A) Eastern Cooperative Oncology Group (ECOG) performance status 0 or 1

Study design

Primary purpose: Treatment, Allocation: Randomized, Intervention model: Parallel Assignment, Masking: Triple, Subject masked: Yes, Caregiver masked: Yes, Investigator masked: Yes,

Conditions

Carcinoma, Hepatocellular

Other study ID numbers

CA224-106; 2021-003606-53; U1111-1267-1579

Choose trial site (105)

USC Norris Comprehensive Cancer Center
1441 Eastlake Ave, Los Angeles, CA 90033, USA
University Of California - Los Angeles
Los Angeles, CA 90095, USA
Albert Einstein School of Medicine Montefiore
1300 Morris Park Ave, The Bronx, NY 10461, USA
$Form.Name
New York, NY 10065, USA
Local Institution - 0045
Camperdown NSW 2050, Australia
Local Institution - 0026
Heidelberg VIC 3084, Australia
Local Institution - 0017
Nedlands WA 6009, Australia
Local Institution - 0031
China
Local Institution
93140 Bondy, France
Local Institution - 0012
Grenoble, France
Local Institution - 0001
Nice, France
Local Institution - 0055
81377 Munich, Germany
Local Institution - 0058
920-8641, Japan
Local Institution - 0050
232-0024, Japan
Local Institution - 0028
85-796 Bydgoszcz, Poland
Local Institution - 0016
02-034 Warsaw, Poland
Pan American Center for Oncology Trials, LLC
San Juan, 00935, Puerto Rico
Local Institution - 0019_NA
San Juan, 00927, Puerto Rico
Local Institution - 0018
Singapore
Local Institution - 0032
15706 Santiago de Compostela, A Coruña, Spain
Local Institution - 0007
39008 Santander, Cantabria, Spain
Local Institution - 0053
28046 Madrid, Spain
Local Institution - 0038
31008 Pamplona, Navarre, Spain
Local Institution - 0040
50009 Zaragoza, Spain
Local Institution - 0043
North District, Taichung City, Taiwan 404
Local Institution
Taichung, North District, Taichung City, Taiwan
Local Institution
Taipei City, Taiwan
Farrer Park
University of California - Los Angeles
Los Angeles, CA 90095, USA
California Pacific Hematology Oncology Associates
2100 Webster St # 225, San Francisco, CA 94115, USA
Georgetown University Medical Center - Lombardi Comprehensive Cancer Center
37th and O Street, N.W., Washington, DC 20057, USA
Johns Hopkins Medicine - Sidney Kimmel Comprehensive Cancer Center
401 N Broadway, Baltimore, MD 21231, USA
Harvard Medical School - Massachusetts General Hospital MGH - Cancer Center
Boston, MA, USA
Beth Israel Deaconess Medical Center
330 Brookline Ave, Boston, MA 02215, USA
Memorial Sloan Kettering Cancer Center
1275 York Ave, New York, NY 10065, USA
Medical College of Wisconsin/ Froedtert Hospital
9200 W Wisconsin Ave, Wauwatosa, WI 53226, USA
Local Institution - 0022
Institute Building, Adelaide SA 5000, Australia
Local Institution - 0013
13 Fitzroy St, Fitzroy VIC 3065, Australia
Local Institution - 0025
Edmonton, AB T5M 0V9, Canada
Local Institution - 0009
Toronto, ON M5G 2M9, Canada
Local Institution - 0064
Baiyun, Guangzhou, China, 510515
Local Institution - 0066
Xi'An, Shaanxi, China
Local Institution - 0021
Avignon, France
Local Institution - 0002
51100 Reims, France
Local Institution - 0008
Rennes, France
Local Institution - 0054
92150 Suresnes, France
Local Institution - 0035
Frankfurt, Germany
Local Institution - 0051
40225 Düsseldorf, Germany
Local Institution - 0057
55131 Mainz, Germany
Local Institution - 0004
Hong Kong
Local Institution - 0020
20089 Rozzano, Metropolitan City of Milan, Italy
Local Institution - 0036
20122 Milan, Metropolitan City of Milan, Italy
Local Institution - 0003
35128 Padua, Province of Padua, Italy
Local Institution - 0010
00168 Rome, Metropolitan City of Rome Capital, Italy
Local Institution - 0047
277-8577, Japan
Local Institution - 0041
589-8511, Japan
Local Institution - 0063
104-0045, Japan
Local Institution - 0037
Seongnam-si, Gyeonggi-do, South Korea
Local Institution - 0056
577-92 Banpo-dong, Seocho-gu, Seoul, South Korea
Local Institution - 0023
80-219 Gdańsk, Poland
Local Institution - 0019
San Juan, 00927, Puerto Rico
Local Institution - 0029
Singapore 169610
Local Institution - 0027
Singapore 217562
Local Institution - 0044
Singapore 329563
Local Institution - 0067
31008 Pamplona, Navarre, Spain
Local Institution - 0024
Taichung, North District, Taichung City, Taiwan
Local Institution - 0046
Taipei City, Taiwan
Local Institution - 0049
Taipei City, Taiwan
Tan Tock Seng Hospital Singapore
National Cancer Centre Singapore
Local Institution - 0037
Bundang-gu, Seongnam-si, Gyeonggi-do, South Korea
Local Institution - 0056
Songpa-gu, Seoul, South Korea
Local Institution - 0029
Singapore
Harvard Medical School - Massachusetts General Hospital MGH - Cancer Center
25 Shattuck St, Boston, MA 02115, USA
Local Institution - 0031
Sha Tin, Hong Kong
Local Institution - 0020
20089 Rozzano, Metropolitan City of Milan, Italy
Local Institution - 0048
790-0024, Japan
Local Institution - 0041
589-8511, Japan
Local Institution - 0058
920-8641, Japan
Princess Margaret Hospital
610 University Ave, Toronto, ON M5G 2C4, Canada
Nanfang Hospital, Southern Medical University
1838 Guang Zhou Da Dao Bei, Bai Yun Qu, Guang Zhou Shi, Guang Dong Sheng, China, 510515
Xian International Medical Center Hospital
Xi An Wai Shi Xue Yuan, 电子城 Yan Ta Qu, Xi An Shi, Shan Xi Sheng, China, 710065
Centre Eugène Marquis Rennes - Centre de Lutte Contre le Cancer
Av. de la Bataille Flandres-Dunkerque CS 44229, 35000 Rennes, France
University Hospital Frankfurt
Frankfurt, Germany
Universitaetsklinikum Duesseldorf
Moorenstraße 5 Universitätsklinikum, 40225 Düsseldorf, Germany
Universitaetsmedizin der Johannes Gutenberg-University Mainz
Langenbeckstraße 1, 55131 Mainz, Germany
Local Institution - 0036
20122 Milan, Metropolitan City of Milan, Italy
Ehime Prefectural Central Hospital
83 Kasugamachi, Matsuyama, Ehime 790-0024, Japan
Asan Medical Center
88 Olympic-ro 43-gil, Songpa-gu, Seoul, South Korea
Centrum Onkologii im. Prof. Franciszka Aukaszczyka, Ambulatorium Chemioterapii
Doktor Izabeli Romanowskiej 2, 85-796 Bydgoszcz, Poland
M Sklodowska Curie Memorial National Cancer Institute
Samarytanka 51, 03-588 Warszawa, Poland
Tan Tock Seng Hospital
11 Jln Tan Tock Seng, Singapore 308433
Hospital Universitario La Paz
P.º de la Castellana, 261, Fuencarral-El Pardo, 28046 Madrid, Spain
Hospital Universitario Miguel Servet
P.º de Isabel la Católica, 1-3, 50009 Zaragoza, Spain
Taichung Veterans General Hospital
40705, Taiwan, Taichung City, Xitun District, 台灣大道四段1650號
National Taiwan University Hospital NTUH
No. 7號, Zhongshan S Rd, Zhongzheng District, Taipei City, Taiwan 100
Centre Hospitalier Universitaire de Nice Hopital l Archet (Albert Tran)
Nice, France
Centre Eugene Marquis
Av. de la Bataille Flandres-Dunkerque CS 44229, 35000 Rennes, France
Queen Mary Hospital
Queen Mary Hospital Main Block, Pok Fu Lam Rd, Pok Fu Lam, Hong Kong
Oncology Institute Veneto IOV-IRCCS
Padua, Province of Padua, Italy
Yokohama City University Medical Center
Yokohama City University Medical Center, 4-chōme Urafunechō, Minami Ward, Yokohama, Kanagawa 232-0024, Japan
FDI Clinical Research
998 Av. Luis Muñoz Rivera, San Juan, 00927, Puerto Rico
National Cancer Centre
30 Hospital Blvd, Singapore 168583
Clinica Universidad de Navarra
C. del Marquesado de Sta. Marta, 1, San Blas-Canillejas, 28027 Madrid, Spain
Clinica Universidad de Navarra
Av. de Pío XII, 36, 31008 Pamplona, Navarra, Spain