/NCT04567615

Bristol Myers Squibb

Key trial

A Study of Relatlimab in Combination With Nivolumab in Participants With Advanced Liver Cancer Who Have Never Been Treated With Immuno-oncology Therapy After Prior Treatment With Tyrosine Kinase Inhibitors

Trial number:: NCT04567615

Trial phase:: 2

Study type:: Immunotherapy, Targeted therapy

Overall status:: Recruiting

Study start date

February, 2021

Scientific title

A Phase 2, Randomized, Open-label Study of Relatlimab in Combination With Nivolumab in Participants With Advanced Hepatocellular Carcinoma Who Are Naive to IO Therapy But Progressed on Tyrosine Kinase Inhibitors (RELATIVITY-073)

Summary

The purpose of this study is to evaluate the effectiveness and safety of relatlimab in combination with nivolumab in participants with advanced liver cancer who have never been treated with immuno-oncology therapy, after prior treatment with tyrosine kinase inhibitor therapy.

Key

Must have a diagnosis of hepatocellular carcinoma (HCC) based on histological confirmationMust have advanced/metastatic HCC Have to be immunotherapy treatment-naive in the advanced/metastatic setting Must have at least one Response Evaluation Criteria in Solid Tumors (RECIST) v1.1 measurable untreated lesion Child-Pugh score of 5 or 6 Eastern Cooperative Oncology Group (ECOG) performance status 0 or 1 for ECOG performance status scale

Key

Study design

Primary purpose: Treatment, Allocation: Randomized, Intervention model: Parallel Assignment, Masking: None (Open Label),

Conditions

Hepatocellular Carcinoma, Hepatoma, Liver Cancer, Adult, Liver Cell Carcinoma, Liver Cell Carcinoma, Adult

Other study ID numbers

CA224-073; 2018-003151-38; U1111-1218-6499

Choose trial site (158)

Local Institution

24255 Pacific Coast Hwy, Malibu, CA 90263, USA

Local Institution

Buenos Aires, Argentina

Local Institution

Arco Iris 4045, Recoleta, Región Metropolitana, Chile

Local Institution

C. de Abtao, 31, 28007 Madrid, Spain

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C. de la Aduana, 33, 28013 Madrid, Spain

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Av. de la Baja Navarra, 47, 31002 Pamplona, Navarra, Spain

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Buenos Aires, Argentina

Local Institution

Rosario, Santa Fe Province, Argentina

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Charcas 21, T4000 San Miguel de Tucumán, Tucumán, Argentina

Local Institution

Royal Prince Alfred Hospital, Missenden Rd, Sydney NSW 2050, Australia

Local Institution

Av. Brasil, 674 - Santa Efigênia, Belo Horizonte - MG, 30140-001, Brazil

Local Institution

R. Dom Pedro II, 861 - São João, Porto Alegre - RS, 90550-142, Brazil

Local Institution

Av. 25, 723 - Centro, Barretos - SP, 14780-330, Brazil

Local Institution

Galileu Office - R. Galileu Galilei, 1800 - Jardim Irajá, Ribeirão Preto - SP, 14020-620, Brazil

Local Institution

Rua Dona Adma Jafet, 74 - Bela Vista, São Paulo - SP, 01308-050, Brazil

Local Institution

Manuel Bulnes 590, Temuco, Araucanía, Chile

Local Institution

Sta Lucía 240, Santiago, Región Metropolitana, Chile

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Brno, Czechia

Local Institution

Hradecká 1249, 500 03 Hradec Králové, Czechia

Local Institution

Vídeňská 1083, 142 20 Praha 4, Czechia

Hôpital Beaujon-Oncologie Digestive

100 Bd du Général Leclerc, 92110 Clichy, France

Hopital De La Croix Rousse

16 Rue Jacques-Louis Hénon, 69004 Lyon, France

Hopital Du Haut-Leveque

Av. du Haut Lévêque, 33604 Pessac, France

Local Institution

2, Allée du Parc de Brabois, Rue Jean Zay, 54500 Vandœuvre-lès-Nancy, France

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213號 Nam Cheong St, Sham Shui Po, Hong Kong

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８３ Kasugamachi, Matsuyama, Ehime 790-0024, Japan

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Japan, 〒232-0014 Kanagawa, Yokohama, Minami Ward, Yoshinochō, 3-chōme−７−６ＴＳビル

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241-8515, Japan

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377-2 Ōnohigashi, Osakasayama, Osaka 589-8511, Japan

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7-番１号 Ogigaoka, Nonoichi, Ishikawa 921-8501, Japan

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465 Kajiichō, Kamigyo Ward, Kyoto, 602-8566, Japan

Local Institution

South Korea, Gyeonggi-do, Seongnam-si, Bundang-gu, Yatap-dong, Saenari-ro, 25 KETI 한국전자기술연구원

Local Institution

1800 K St NW 3rd floor, Washington, DC 20006, USA

Local Institution

1800 K St NW 3rd floor, Washington, DC 20006, USA

Local Institution

155 Queen Street, Auckland CBD, Auckland 1010, New Zealand

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Rynek, 41-902 Bytom, Poland

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Świętej Anny 12, 31-008 Kraków, Poland

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Starokościelna 8, 41-400 Mysłowice, Poland

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Wilcza 9, 00-538 Warszawa, Poland

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Bucharest, Romania

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Strada Republicii 34-36, Cluj-Napoca 400015, Romania

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Strada Alexandru Ioan Cuza 13, Craiova 200585, Romania

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Aleea Cetății, Suceava 720003, Romania

Local Institution

Moskvorechie Str., 1, rooms 302 & 414, Moskva, Russia, 115478

Local Institution

10 Lower Kent Ridge Rd, Singapore 119076

National Cancer Centre Singapore

11 Hospital Cres, Singapore 169610

Tan Tock Seng Hospital Singapore

11 Jln Tan Tock Seng, Level 1, Singapore 308433

Local Institution

Carrer del Rosselló, 132, 08036 Barcelona, Spain

Local Institution

Av. Menéndez Pidal, S/N, 14004 Córdoba, Spain

Local Institution

Paseo Dr. Begiristain, s/n, 20014 San Sebastián, Gipuzkoa, Spain

Local Institution

8600 Rockville Pike, Bethesda, MD 20894, USA

Local Institution

No. 280號, Kaiyuan Rd, North District, Tainan City, Taiwan 704

Local Institution

100, Taiwan, Taipei City, Zhongzheng District, Section 1, Heping W Rd, 20號12樓

Local Institution

3731 Wilshire Blvd #700, Los Angeles, CA 90010, USA

Local Institution

No. 250號, Wenhua 1st Rd, Guishan District, Taoyuan City, Taiwan 333

Local Institution

10°59'16. 74°48'33., Cl. 4 #5"N, Puerto Colombia, Barranquilla, Atlántico, Colombia

Local Institution

Dg. 33 Bis A #1516, Bogotá, Cundinamarca, Colombia

Masarykuv onkologicky ustav-Klinika komplexni onkologicke pece

Žlutý kopec 543/7, 602 00 Brno-střed-Staré Brno, Czechia

Fakultni nemocnice Hradec Kralove-Klinika onkologie a radioterapie

Sokolská 581, 500 05 Hradec Králové, Czechia

Fakultni Thomayerova nemocnice - Onkologicka klinika 1. LF UK

Vídeňská 800, 140 00 Praha 4, Czechia

CHU de Nancy Hopitaux de Brabois

Rue du Morvan, 54500 Vandœuvre-lès-Nancy, France

Local Institution

Av. Álvaro Obregón 185-4to Piso, Roma Nte., Cuauhtémoc, 06700 Ciudad de México, CDMX, Mexico

Local Institution

Jardín Colón 23, Barrio de San Miguelito, 78339 San Luis, S.L.P., Mexico

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Kraków, Poland

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Adolfa Pawińskiego 5, 02-106 Warszawa, Poland

Local Institution

Güvenevler, Cinnah Cd. No:20, 06540 Çankaya/Ankara, Turkey

Local Institution

Çankaya, Atatürk Blv No:154, 06690 Çankaya/Ankara, Turkey

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Edirne, Edirne Merkez/Edirne, Turkey

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Hasanpasa Mahallesi, Lavanta Sk Etap is merkezi c blok No:16 kat:2, Hasanpaşa, D:aire:7, 34722 Kadıköy/İstanbul, Turkey

Local Institution

1300 Pennsylvania Avenue NW, Washington, DC 20004, USA

Local Institution

Maipú 1065, S2000CGK Rosario, Santa Fe, Argentina

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Pl. de Armas, Santiago, Región Metropolitana, Chile

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46 Av. Félix Viallet, 38031 Grenoble, France

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C. Cofre de Perote 1014, Volcanes, 68020 Oaxaca de Juárez, Oax., Mexico

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Strada Locotenent Virgil Lazarovici 34, București 021871, Romania

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Splaiul Independenței 296, București 060031, Romania

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Blvd. Rondeau 3584, Local 8 2000, S2005PCO Rosario, Santa Fe, Argentina

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319 Yueyang Rd, Xu Hui Qu, Shang Hai Shi, China, 200031

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1 a 16, Cl. 16 Sur, Bogotá, Colombia

Local Institution - 0010

Buenos Aires, Argentina

Local Institution - 0019

Buenos Aires, Argentina

Local Institution - 0017

Rosario, Santa Fe Province, Argentina

Local Institution - 0063

San Miguel de Tucumán, Tucumán, Argentina

Oncologia de Preciso e Personalizada

R. Padre Rolim - Santa Efigênia, Belo Horizonte - MG, 30130-090, Brazil

Hospital Nossa Senhora da Conceição-Centro Integrado de Pesquisa em Oncologia

Av. Francisco Trein, 596 - Sala 3140 - Bloco E - Cristo Redentor, Porto Alegre - RS, 91350-200, Brazil

Fundação Pio XII - Hospital de Câncer de Barretos-Unidade de Pesquisa Clínica

R. Antenor Duarte Viléla, 1331 - Dr. Paulo Prata, Barretos - SP, 14784-400, Brazil

Unidade de Pesquisa Clínica do Hospital da Clínicas de Ribeirão Preto-Clinical Oncology

R. Ten. Catão Roxo, 3900 - Vila Monte Alegre, Ribeirão Preto - SP, 14015-010, Brazil

Local Institution - 0015

Av. Dr. Arnaldo - Pacaembu, São Paulo - SP, 01246-000, Brazil

Local Institution - 0024

Temuco, Araucania, Chile

Local Institution - 0029

Santiago Metropolitan Region, Chile

Local Institution - 0018

Santiago Metropolitan Region, Chile

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Harbin, Heilongjiang, China

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Yuelu District, Changsha, China, 410013

Local Institution - 0118

Xi'An, China, 710061

Local Institution - 0108

Xi'An, Shaanxi, China

Local Institution - 0107

China, 200032

Local Institution

Hangzhou, China, 310016

Local Institution - 0048

Brno, Czechia

Local Institution - 0047

500 05 Hradec Kralove, Czechia

Local Institution - 0046

Prague, Czechia

Local Institution - 0068

92110 Clichy, France

Local Institution - 0105

Grenoble, France

Local Institution - 0074

69004 Lyon, France

Local Institution - 0067

33600 Pessac, France

Local Institution - 0069

54500 Vandœuvre-lès-Nancy, France

Local Institution - 0077

Hong Kong

Local Institution - 0079

Sha Tin, Hong Kong

Local Institution - 0072

790-0024, Japan

Local Institution - 0054

232-0024, Japan

Local Institution - 0076

241-8515, Japan

Local Institution - 0075

920-8641, Japan

Local Institution - 0071

Japan 〒602-8566

Local Institution - 0011

South Korea, Seoul, 논현동 114-24번지 강남구 서울특별시 KR

Local Institution - 0020

Seongnam-si, Gyeonggi-do, South Korea

Local Institution - 0043

Seoul, South Korea

Local Institution - 0100

Roma Nte., 06700 Ciudad de México, CDMX, Mexico

Local Institution - 0101

Tequis, 78250 San Luis, S.L.P., Mexico

Local Institution - 0106

Agencia Municipal de Donaji, 68020 Oaxaca de Juárez, Oax., Mexico

Local Institution - 0003

Auckland 1023, New Zealand

Local Institution - 0012

41-900 Bytom, Poland

Local Institution - 0009

41-400 Mysłowice, Poland

Local Institution - 0039

02-034 Warsaw, Poland

Local Institution - 0037

Bucharest, Romania

Local Institution - 0036

Cluj-Napoca, Romania

Local Institution - 0038

Craiova, Romania

Local Institution - 0070

Suceava 720214, Romania

Local Institution

Moscow, Russia, 121205

Local Institution - 0001

Singapore 169610

Local Institution - 0004

Singapore 308433

Local Institution - 0066

08036 Barcelona, Spain

Local Institution - 0073

14004 Córdoba, Spain

Local Institution - 0051

28009 Madrid, Spain

Local Institution - 0049

28041 Madrid, Spain

Local Institution - 0058

31008 Pamplona, Navarre, Spain

Local Institution - 0050

20014 Donostia-San Sebastian, Gipuzkoa, Spain

Local Institution - 0041

Taichung, North District, Taichung City, Taiwan

Local Institution - 0034

North District, Tainan City, Taiwan 704

Local Institution - 0031

Taipei City, Taiwan

Local Institution - 0042

Taipei City, Taiwan

Local Institution - 0032

Guishan District, Taoyuan City, Taiwan 333

Local Institution - 0017

Rosario, Santa Fe Province, Argentina

Local Institution - 0024

4800827 Temuco, Araucania, Chile

Local Institution - 0113

Harbin, Heilongjiang, China

Local Institution - 0114

Yuelu District, Changsha, China, 410013

Local Institution - 0117

Hangzhou, China, 310016

Local Institution - 0069

69 Rue de Vandoeuvre, 54180 Heillecourt, France

Local Institution - 0045

589-8511, Japan

Local Institution - 0011

Songpa-gu, Seoul, South Korea

Local Institution - 0100

Roma Nte., 06700 Ciudad de México, CDMX, Mexico

Local Institution - 0013

31-501 Kraków, Poland

Local Institution - 0038

Craiova, Romania

Local Institution - 0050

20014 Donostia-San Sebastian, Gipuzkoa, Spain

Local Institution - 0089

Hacettepe, 06230 Altındağ/Ankara, Türkiye

Local Institution - 0090

Edirne, Edirne Merkez/Edirne, Türkiye

Local Institution - 0091

Kadıköy/İstanbul, Türkiye

Local Institution - 0025

Av. Prof. Alfredo Balena, 190 - Santa Efigênia, Belo Horizonte - MG, 30130-100, Brazil

Local Institution - 0060

R. Adão Baino, 206 - Cristo Redentor, Porto Alegre - RS, 91350-240, Brazil

Local Institution - 0001

335 Smith St, Singapore 050335