A Clinical Trial of a New Combination Treatment, Domvanalimab and Zimberelimab, Plus Chemotherapy, for People With an Upper Gastrointestinal Tract Cancer That Cannot be Removed With Surgery That Has Spread to Other Parts of the Body

PHASE3Active, not recruitingINTERVENTIONAL
Enrollment

1,040

Participants

Timeline

Start Date

November 21, 2022

Primary Completion Date

December 31, 2026

Study Completion Date

February 28, 2027

Conditions
Advanced Upper Gastrointestinal Tract Adenocarcinoma
Interventions
DRUG

Domvanalimab

Intravenous (IV) Aqueous Solution

DRUG

Zimberelimab

IV Aqueous Solution

DRUG

Capecitabine

Oral Tablets

DRUG

Fluorouracil

IV Aqueous Solution

DRUG

Leucovorin

IV Aqueous Solution

DRUG

Oxaliplatin

IV Aqueous Solution

DRUG

Nivolumab

IV Aqueous Solution

Trial Locations (210)

112

LLC Todua Clinic, Tbilisi

144

Ltd Tbilisi State Medical University and Ingorokva High Medical Technology University Clinic, Tbilisi

159

New Vision University Hospital, Tbilisi

186

"Multi-profile Clinic New Hospitals", Tbilisi

3100

Centro Especializado en Investigacion y Tratamiento Oncologicos SC, Mexico City

4600

Evex Hospitals - Kutaisi Referral Hospital, Kutaisi

10016

Perlmutter Cancer Center - 38th Street, New York

10065

Memorial Sloan Kettering Cancer Center - New York, New York

11501

Perlmutter Cancer Ctr NYU, Mineola

22031

USOR - Virginia Cancer Specialists - Fairfax Office, Fairfax

22057

Georgetown Lombardi Comprehensive Cancer Center, Washington D.C.

27710

Duke University Medical Center, Durham

29605

Prisma Health Cancer Institute, Greenville

32308

SCRI - Florida Cancer Specialists - Panhandle Research Office, Tallahassee

33401

SCRI - Florida Cancer Specialists - East Region Research Office, West Palm Beach

33705

SCRI - Florida Cancer Specialists - North Region Research Office, St. Petersburg

33901

SCRI - Florida Cancer Specialists - South Region Research Office, Fort Myers

37203

Tennessee Oncology - Chattanooga - Memorial Plaza, Nashville

Tennessee Oncology - Nashville - Centennial, Nashville

37232

Vanderbilt - Ingram Cancer Center, Nashville

40202

University of Louisville James Graham Brown Cancer Center, Louisville

40217

Norton Cancer Institute - Poplar Level Road, Louisville

43219

Mark H. Zangmeister Cancer Center, Columbus

44106

Cleveland Clinic - Taussig Cancer Center, Cleveland

University Hospitals Cleveland Medical Center, Cleveland

44111

Cleveland Clin - Fairview Hosp, Cleveland

44124

Cleveland Clin-Hillcrest Hosp, Mayfield Heights

48109

University of Michigan Rogel Cancer Center, Ann Arbor

50120

Centro Hemato - Oncológico Privado (CHOP), Toluca

53226

Froedtert Clinical Cancer Center, Milwaukee

55426

HealthPartners Cancer Center at Regions Hospital, Saint Louis Park

Regions Hospital, Saint Louis Park

66278

Hospital Zambrano Hellion TecSalud, San Pedro Garza García

70121

Ochsner Cancer Institute, New Orleans

71913

Genesis Cancer Center and Blood Institute - Hot Springs, Hot Springs

75390

University of Texas Southwestern Medical Center, Dallas

76104

The Center for Cancer & Blood Disorders - Fort Worth, Fort Worth

77054

Harris Health System, Houston

90027

Kaiser Permanente - Los Angeles Medical Center, Los Angeles

90033

Norris Comprehensive Cancer Center, Los Angeles

90404

UCLA Health - Santa Monica Cancer Care, Santa Monica

92868

University of California Irvine Health Chao Family Comprehensive Cancer Center, Orange

94300

CLIMERS Clinical Medical Research, Colonia Centro

97134

Centro de Atención e Investigación Clínica en Oncología, Mérida

97225

Prov Care Clinic - Westside, Portland

Providence Cancer Center Oncology and Hematology Care Westside Portland, Portland

98109

Fred Hutchinson Cancer Center - Seattle Cancer Care Alliance (SCCA) Location, Seattle

06520

Yale Cancer Center, New Haven

02114

Massachusetts General Hospital, Boston

Unknown

Hospital Británico de Buenos Aires, Buenos Aires

CORI, La Rioja

Instituto de Investigaciones Clínicas Mar del Plata, Mar del Plata

Monash University, Clayton

Gosford Hospital, Gosford

Liverpool Hospital, Liverpool

Oncology West - Murdoch, Murdoch

Fundação Pio XII - Hospital de Câncer de Barretos - Hospital de Amor, Barretos

ONCOSITE - Centro de Pesquisa Clinica Em Oncologia Ltda., Ijuí

Liga Contra o Câncer - Centro Avançado de Oncologia, Natal

Hospital Ernesto Dornelles, Porto Alegre

Instituto Nacional de Câncer - Brazil, Rio de Janeiro

Queen Elizabeth II Health Sciences Centre-Victoria General, Halifax

Hôpital Notre-Dame, Montreal

Ottawa Hospital - General Campus, Ottawa

Princess Margaret Cancer Centre, Toronto

Sunnybrook Health Sciences Centre - Bayview Campus, Toronto

Icegclinic, La Florida

Hospital Puerto Montt, Port Montt

Oncovida - Santiago, Providencia

Bradford Hill Centro de Investigaciones Clinicas, Recoleta

Centro de Estudios Clínicos SAGA, Santiago

Pontificia Universidad Catolica de Chile - Escuela De Medicina - Clinica UC San Carlos de Apoq, Santiago

Clínica Universidad Católica del Maule - Talca, Talca

1st Hosp of Jilin University, Changchun

1st People's Hosp of Changzhou, Changzhou

900 Hospital, Fuzhou

Guangdong PR People's Hospital, Guangzhou

Sun Yat-Sen Cancer Center, Guangzhou

Hainan General Hospital, Haikou

Sir Run Run Shaw Hospital, Hangzhou

Zhejiang Cancer Hospital, Hangzhou

2nd hosp Anhui Med University, Hefei

Anhui Provincial Hospital, Hefei

Shanghai East Hospital, Shanghai

Tianjin Cancer Hospital, Tianjin

Qinghai UNV Afl Hospital, Xining

Henan Cancer Hospital, Zhengzhou

Institut Bergonié, Bordeaux

Hôpital Morvan, Brest

Centre de Lutte contre le Cancer - François Baclesse, Caen

Hôpital Claude Huriez, Lille

Centre Léon Bérard, Lyon

Hôpital de la Timone, Marseille

Institut Régional du Cancer de Montpellier, Montpellier

Centre Armoricain de Radiothérapie, d'Imagerie Médicale et d'Oncologie, Plérin

Centre Hospitalier Universitaire de Poitiers, Poitiers

CHU de Toulouse - Hopital Rangueil, Toulouse

Institut Gustave Roussy, Villejuif

Clínica Privada Dr. Rixci Ramírez, Guatemala City

Grupo Medico Angeles, Guatemala City

INTEGRA Cancer Institute, Guatemala City

Medi-k Cayalá, Guatemala City

Centro Regional de Sub Especialidades Médicas (CRESEM) SA, Quetzaltenango

Hong Kong Sanatorium and Hosp, Happy Valley

Humanity & Health Clinical Trial Centre, Hong Kong

Queen Mary Hospital - Hong Kong, Hong Kong

Tuen Mun Hospital, Tuenmen

Dél-pesti Centrumkórház - Országos Hematológiai és Infektológiai Intézet, Budapest

Országos Onkológiai Intézet, Budapest

Bács-Kiskun Megyei Oktatókórház - Kecskemét, Kecskemét

Pécsi Tudományegyetem Klinikai Központ, Pécs

Hadassah University Hospital Ein Kerem, Jerusalem

Shaare Zedek Medical Center, Jerusalem

Davidoff Cancer Center, Petah Tikva

Tel Aviv Sourasky Medical Center, Tel Aviv

Azienda Ospedaliero - Universitaria Careggi, Florence

Istituto di Ricovero e Cura a Carattere Scientifico (IRCCS) - Ospedale San Raffaele, Milan

Istituto Europeo di Oncologia, Milan

Ospedale Santa Maria Croci, Ravenna

Istituto di Ricovero e Cura a Carattere Scientifico (IRCCS) - Istituto Clinico Humanitas, Rozzano

Azienda Sanitaria Universitaria Friuli Centrale ? P.O. Santa Maria della Misericordia, Udine

Hyogo Cancer Center, Akashi

Tokyo Metro Ctr, Bunkyō City

University of Tokyo Hospital, Bunkyō City

Chiba Cancer Center, Chiba

Kyushu Cancer Center, Fukuoka

Nat Cancer Ctr-Kashiwa Campus, Kashiwa-shi

St. Marianna Uni Hosp, Kawasaki

Cancer Inst Hosp of JFCR, Kōtō City

Kumamoto University Hospital, Kumamoto

Shikoku Cancer Center, Matsuyama

Shizuoka Cancer Center, Nagaizumi-cho

Aichi Cancer Center, Nagoya

Niigata Cancer Center Hospital, Niigata

Osaka Prefectural Hosp Org, Osaka

Kindai University Hospital, Osakasayama-shi

Gunma Prefectural Cancer Ctr, Ota-shi

Saitama Cancer Center, Saitama

National Cancer Ctr Hosp, Tokyo

Kanagawa Cancer Center, Yokohama

Kauno Klinikos, Kaunas

Klaipedos Universitetine Ligonine, Klaipėda

Nacionalinis Vėžio Institutas, Vilnius

Vilniaus Universiteto Ligoninė Santariškių Klinikos, Vilnius

Hospital Pulau Pinang, George Town

Hospital Kuala Lumpur, Kuala Lumpur

Pusat Perubatan Universiti Malaya, Kuala Lumpur

Hospital Umum Sarawak, Kuching

Hosp Nacional Daniel Carrion, Bellavista

SANNA - Clínica El Golf, San Isidro

Hospital Maria Auxiliadora, San Juán de Miraflores

Instituto Nacional de Enfermedades Neoplásicas, Surquillo

Dr Pablo O. Torre Memorial Hospital - Riverside Medical Center, Bacolod City

Baguio General Hospital and Medical Center, Baguio City

Cebu Doctors' University Hospital, Cebu City

Manila Doctors Hospital, Manila

Centrum Onkologii Ziemi Lubelskiej im. św. Jana z Dukli, Lublin

Samodzielny Publiczny Szpital Kliniczny nr 1 w Lublinie, Lublin

Szpital Miejski w Tychach, Tychy

Narodowy Instytut Onkologii im. Marii Skłodowskiej-Curie - Państwowy Instytut Badawczy, Warsaw

Centro Hospitalar e Universitário de Coimbra, Coimbra

Fundação D. Anna de Sommer Champalimaud e Dr. Carlos Montez Champalimaud, Lisbon

Instituto Português de Oncologia do Porto Francisco Gentil, Porto

Spitalul Judetean de Urgenta, Baia Mare

Institutul Clinic Fundeni, Bucharest

Institutul Oncologic Prof. Dr. Ion Chiricuta, Cluj-Napoca

Medisprof, Cluj-Napoca

Centrul De Oncologie Sf Nectarie, Craiova

Centrul de Radioterapie Amethyst Cluj, Florești

Centrul de Oncologie Euroclinic, Iași

Clinica SIGMedical, Suceava

Institute of Oncology and Radiology of Serbia (Institut za onkologiju i radiologiju Srbije), Belgrade

University Hospital Medical Center (KBC) Bezanijska Kosa, Belgrade

Clinical Center Kragujevac, Kragujevac

Dong-A University Hospital, Busan

Kyungpook Nat Uni Chilgok, Daegu

Cha Bundang Medical Center, Seongnam

Asan Medical Center, Seoul

Korea University Guro Hospital, Seoul

Samsung Medical Center, Seoul

Seoul Nat Uni Hospital, Seoul

Severance Hospital, Seoul

Hospital Universitari Vall d'Hebrón, Barcelona

Institut Català d'Oncologia - Hospital Duran i Reynals (ICO L'Hospitalet), Barcelona

Hospital General Universitario Gregorio Marañón, Madrid

Hospital Universitario HM Sanchinarro, Madrid

Hospital Universitario Ramón y Cajal, Madrid

Hospital Universitario Marqués de Valdecilla, Santander

Hospital Clínico Universitario de Valencia, Valencia

Hospital Universitario Miguel Servet, Zaragoza

Faculty of Medicine Siriraj Hospital, Bang Phlat

Songklanagarind Hospital, Hat Yai

Sunpasitthiprasong Hospital, Ubon Ratchathani

T.C. Saglik Bakanligi Adana Sehir Egitim ve Arastirma Hastanesi, Adana

Memorial Ankara Hastanesi, Ankara

Trakya Universitesi Tip Fakultesi, Edirne

T.C. Saglik Bakanligi - Istanbul Il Saglik Mudurlugu - Goztepe Prof. Dr. Suleyman Yalcin Sehir Hastanesi, Istanbul

Kocaeli Üniversitesi Araştırma ve Uygulama Hastanesi, İzmit

Inönü Üniversitesi Turgut Özal Tıp Merkezi, Malatya

Ankara Üniversitesi Tıp Fakültesi - Cebeci Araştırma ve Uygulama Hastanesi, Mamak

Van Yüzüncü Yıl Üniversitesi Dursun Odabaş Tıp Merkezi, Van

Ataturk Universitesi Arastirma Hastanesi, Yakutiye

Başkent Üniversitesi Adana Dr Turgut Noyan Uygulama ve Araştirma Merkezi, Yüreğir

Barts Health NHS Trust, London

Sarah Cannon Research Institute London, London

The Royal Marsden NHS Foundation Trust, London

University College London Hospitals NHS Foundation Trust, London

The Christie NHS Foundation Trust, Manchester

Oxford University Hospitals NHS Foundation Trust, Oxford

The Royal Marsden NHS Foundation Trust, Sutton

Sponsors

Collaborators (1)

All Listed Sponsors
collaborator

Gilead Sciences

INDUSTRY

collaborator

Taiho Pharmaceutical Co., Ltd.

INDUSTRY

lead

Arcus Biosciences, Inc.

INDUSTRY

NCT05568095 - A Clinical Trial of a New Combination Treatment, Domvanalimab and Zimberelimab, Plus Chemotherapy, for People With an Upper Gastrointestinal Tract Cancer That Cannot be Removed With Surgery That Has Spread to Other Parts of the Body | Biotech Hunter | Biotech Hunter