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 (STAR-221)

A Randomized, Open-Label, Multicenter Phase 3 Trial of Domvanalimab, Zimberelimab, and Chemotherapy Versus Nivolumab and Chemotherapy in Participants With Previously Untreated Locally Advanced Unresectable or Metastatic Gastric, Gastroesophageal Junction, and Esophageal Adenocarcinoma

This randomized Phase 3 open-label study will compare the efficacy of the T-cell immunoglobulin and immunoreceptor tyrosine-based inhibitory motif (ITIM) domain (TIGIT) monoclonal antibody domvanalimab, the anti programmed cell death protein 1 (PD-1) monoclonal antibody zimberelimab, and multiagent chemotherapy versus the anti PD-1 monoclonal antibody nivolumab and multiagent chemotherapy in the first-line treatment of participants with locally advanced unresectable or metastatic gastric, gastroesophageal junction (GEJ), and esophageal adenocarcinoma.

Study Overview

• Status: Recruiting
• Conditions: Advanced Upper Gastrointestinal Tract Adenocarcinoma
• Intervention / Treatment: Drug: Oxaliplatin; Drug: Leucovorin; Drug: Fluorouracil; Drug: Capecitabine; Drug: Nivolumab; Drug: Domvanalimab; Drug: Zimberelimab

• Study Type: Interventional
• Enrollment (Estimated): 970
• Phase: Phase 3

Contacts and Locations

• Study Contact: Name: Medical Director; Phone Number: +1-510-462-3330; Email: ClinicalTrials@arcusbio.com

Study Locations

• Argentina
  • Buenos Aires, Argentina
    • Recruiting
    • Hospital Británico de Buenos Aires
  • La Rioja, Argentina
    • Recruiting
    • CORI Centro Oncológico Riojano Integral
  • Mar Del Plata, Argentina
    • Recruiting
    • Instituto de Investigaciones Clinicas Mar del Plata
• Australia
  • Clayton, Australia
    • Recruiting
    • Monash University
  • Gosford, Australia
    • Recruiting
    • Gosford Hospital
  • Liverpool, Australia
    • Recruiting
    • Liverpool Hospital
  • Murdoch, Australia
    • Recruiting
    • Oncology West - Murdoch
• Brazil
  • Barretos, Brazil
    • Recruiting
    • Fundacao Pio XII - Hospital de Cancer de Barretos - Hospital de Amor
  • Ijuí, Brazil
    • Recruiting
    • ONCOSITE - Centro de Pesquisa Clinica Em Oncologia Ltda.
  • Natal, Brazil
    • Recruiting
    • Liga Contra o Câncer - Centro Avançado de Oncologia
  • Porto Alegre, Brazil
    • Recruiting
    • Hospital Ernesto Dornelles
  • Rio De Janeiro, Brazil
    • Recruiting
    • Instituto Nacional de Câncer - Brazil
• Canada
  • Charlottetown, Canada
    • Recruiting
    • Queen Elizabeth II Health Sciences Centre-Victoria General
  • Ottawa, Canada
    • Recruiting
    • Ottawa Hospital - General Campus
  • Québec, Canada
    • Recruiting
    • Hopital Notre-Dame
  • Toronto, Canada
    • Recruiting
    • Princess Margaret Cancer Centre
  • Toronto, Canada
    • Recruiting
    • Sunnybrook Health Sciences Centre - Bayview Campus
• Chile
  • La Florida, Chile
    • Recruiting
    • Icegclinic
  • Providencia, Chile
    • Recruiting
    • Oncovida - Santiago
  • Puerto Montt, Chile
    • Recruiting
    • Hospital Puerto Montt
  • Recoleta, Chile
    • Recruiting
    • Bradford Hill Centro de Investigaciones Clinicas1
  • Santiago, Chile
    • Recruiting
    • Centro de Estudios Clínicos SAGA
  • Santiago, Chile
    • Recruiting
    • Pontificia Universidad Catolica de Chile - Escuela De Medicina - Clinica UC San Carlos de Apoq
  • Talca, Chile
    • Recruiting
    • Clínica Universidad Católica del Maule - Talca
• France
  • Bordeaux, France
    • Recruiting
    • Institut Bergonié
  • Brest, France
    • Recruiting
    • Hopital Morvan
  • Caen, France
    • Recruiting
    • Centre de Lutte contre le Cancer - Francois Baclesse
  • Lille, France
    • Recruiting
    • Hôpital Claude Huriez
  • Lyon, France
    • Recruiting
    • Centre Léon Bérard
  • Marseille, France
    • Recruiting
    • Hôpital de la Timone
  • Montpellier, France
    • Recruiting
    • Institut Régional Du Cancer de Montpellier
  • Plérin, France
    • Recruiting
    • Centre Armoricain de Radiothérapie, d?Imagerie Médicale et d?Oncologie
  • Poitiers, France
    • Recruiting
    • Centre Hospitalier Universitaire de Poitiers
  • Toulouse, France
    • Recruiting
    • Centre Hospitalier Universitaire de Toulouse - Hôpital Rangueil
  • Villejuif, France
    • Recruiting
    • Institut Gustave Roussy
• Georgia
  • Kutaisi, Georgia
    • Recruiting
    • Evex Hospitals - Kutaisi Referral Hospital
  • Tbilisi, Georgia
    • Recruiting
    • LLC Todua Clinic
  • Tbilisi, Georgia
    • Recruiting
    • Ltd Tbilisi State Medical University and Ingorokva High Medical Technology University Clinic
  • Tbilisi, Georgia
    • Recruiting
    • New Vision University Hospital
  • Tbilisi, Georgia
    • Recruiting
    • Multi-profile Clinic "New Hospitals"
• Greece
  • Athens, Greece
    • Recruiting
    • Evgenidion Clinic SA - Agia Trias
  • Néa Kifisiá, Greece
    • Recruiting
    • General Oncology Hospital of Kifisias "Agioi Anargyroi"
  • Néo Fáliro, Greece
    • Recruiting
    • Metropolitan Hospital
  • Thessaloníki, Greece
    • Recruiting
    • BioClinic Thessaloniki
• Guatemala
  • Guatemala, Guatemala
    • Recruiting
    • Clínica Privada Dr. Rixci Ramírez
  • Guatemala, Guatemala
    • Recruiting
    • INTEGRA Cancer Institute
  • Guatemala city, Guatemala
    • Recruiting
    • Grupo Medico Angeles
  • Guatemala city, Guatemala
    • Recruiting
    • Medi-k Cayalá
  • Quetzaltenango, Guatemala
    • Recruiting
    • Centro Regional de Sub Especialidades Médicas (CRESEM) SA
• Hong Kong
  • Happy Valley, Hong Kong
    • Recruiting
    • Hong Kong Sanatorium and Hospital
  • Happy Valley, Hong Kong
    • Recruiting
    • Tuen Mun Hospital
  • Hong Kong, Hong Kong
    • Recruiting
    • Humanity and Health Clinical Trial Centre
    • Contact: Chi Pan Lau
  • Hong Kong, Hong Kong
    • Recruiting
    • Queen Mary Hospital - Hong Kong
• Hungary
  • Budapest, Hungary
    • Recruiting
    • Del-pesti Centrumkorhaz - Orszagos Hematologiai es Infektologiai Intezet
  • Budapest, Hungary
    • Recruiting
    • Országos Onkológiai Intézet
  • Kecskemét, Hungary
    • Recruiting
    • Bács-Kiskun Megyei Oktatókórház - Kecskemét
  • Pécs, Hungary
    • Recruiting
    • Pecsi Tudomanyegyetem Klinikai Kozpont
• Israel
  • Jerusalem, Israel
    • Recruiting
    • Hadassah University Hospital Ein Kerem
  • Jerusalem, Israel
    • Recruiting
    • Shaare Zedek Medical Center
  • Petah tikva, Israel
    • Recruiting
    • Shaare Zedek Medical Center
  • Tel Aviv, Israel
    • Recruiting
    • Tel Aviv Sourasky Medical Center
• Italy
  • Firenze, Italy, 50134
    • Recruiting
    • Azienda Ospedaliero Universitaria Careggi-S.O.D. Patologia Medica
  • Milan, Italy
    • Recruiting
    • Istituto di Ricovero e Cura a Carattere Scientifico (IRCCS) - Ospedale San Raffaele
  • Milano, Italy, 20141
    • Recruiting
    • Instituto Europeo di Oncologia
  • Ravenna, Italy
    • Recruiting
    • Ospedale Santa Maria delle Croci di Ravenna
  • Rozzano, Italy
    • Recruiting
    • Istituto di Ricovero e Cura a Carattere Scientifico (IRCCS) - Istituto Clinico Humanitas
  • Udine, Italy
    • Recruiting
    • Azienda Sanitaria Universitaria Friuli Centrale ? P.O. Santa Maria della Misericordia
• Japan
  • Akashi, Japan
    • Recruiting
    • Hyogo Cancer Center
  • Chiba, Japan
    • Recruiting
    • Chiba Cancer Center
  • Fukuoka, Japan
    • Recruiting
    • Kyushu Cancer Center
  • Kashiwa, Japan
    • Recruiting
    • National Cancer Center - Kashiwa Campus
  • Kawasaki, Japan
    • Recruiting
    • St. Marianna University Hospital
  • Koto-Ku, Japan
    • Recruiting
    • Cancer Institute Hospital of JFCR
  • Kumamoto, Japan
    • Recruiting
    • Kumamoto University Hospital
  • Matsuyama, Japan
    • Recruiting
    • Shikoku Cancer Center
  • Nagaizumi-chō, Japan
    • Recruiting
    • Shizuoka Cancer Center
  • Nagoya, Japan
    • Recruiting
    • Aichi Cancer Center
  • Niigata, Japan
    • Recruiting
    • Niigata Cancer Center Hospital
  • Osaka, Japan
    • Recruiting
    • Osaka Prefectural Hospital Organization - Osaka International Cancer Institute
  • Saitama, Japan
    • Recruiting
    • Saitama Cancer Center
  • Sapporo, Japan
    • Recruiting
    • Teine Keijinkai Hospital
  • Tokyo, Japan
    • Recruiting
    • National Cancer Center Hospital
  • Yokohama, Japan
    • Recruiting
    • Kanagawa Cancer Center
  • Ōsaka-sayama, Japan
    • Recruiting
    • Kindai University Hospital
  • Ōta, Japan
    • Recruiting
    • Gunma Prefectural Cancer Center
• Korea, Republic of
  • Busan, Korea, Republic of
    • Recruiting
    • Dong-a University hospital
  • Busan, Korea, Republic of
    • Recruiting
    • Kosin University Gospel Hospital
  • Daegu, Korea, Republic of
    • Recruiting
    • Kyungpook National University Chilgok Hospital
  • Seongnam-si, Korea, Republic of
    • Recruiting
    • CHA Bundang Medical Center
  • Seoul, Korea, Republic of
    • Recruiting
    • Asan Medical Center
  • Seoul, Korea, Republic of
    • Recruiting
    • Severance Hospital
  • Seoul, Korea, Republic of
    • Recruiting
    • Samsung Medical Center
  • Seoul, Korea, Republic of
    • Recruiting
    • Korea University Guro Hospital
• Lithuania
  • Kaunas, Lithuania
    • Recruiting
    • Kauno Klinikos
  • Klaipėda, Lithuania
    • Recruiting
    • Klaipedos Universitetine Ligonine
  • Vilnius, Lithuania
    • Recruiting
    • Nacionalinis vezio institutas
  • Vilnius, Lithuania
    • Recruiting
    • Vilniaus Universiteto Ligoninė Santariškių Klinikos
• Malaysia
  • George Town, Malaysia
    • Recruiting
    • Hospital Pulau Pinang
  • Kuala Lumpur, Malaysia
    • Recruiting
    • Hospital Kuala Lumpur
  • Kuala Lumpur, Malaysia
    • Recruiting
    • Pusat Perubatan Universiti Malaya
  • Kuching, Malaysia
    • Recruiting
    • Hospital Umum Sarawak
• Mexico
  • Colonia Centro, Mexico
    • Recruiting
    • CLIMERS Clinical Medical Research
  • Mexico City, Mexico
    • Recruiting
    • Centro Especializado en Investigacion y Tratamiento Oncologicos SC
  • Mérida, Mexico
    • Recruiting
    • Centro de Atención e Investigación Clínica en Oncología
  • San Pedro Garza Garcia, Mexico
    • Recruiting
    • Hospital Zambrano Hellion TecSalud
  • Toluca, Mexico
    • Recruiting
    • Centro Hemato - Oncológico Privado (CHOP)
• Peru
  • San Isidro, Peru
    • Recruiting
    • SANNA - Clínica El Golf
  • San Juan De Miraflores, Peru
    • Recruiting
    • Hospital Maria Auxiliadora
  • Surquillo, Peru
    • Recruiting
    • Instituto Nacional de Enfermedades Neoplasicas
• Philippines
  • Bacolod, Philippines
    • Recruiting
    • Dr Pablo O. Torre Memorial Hospital - Riverside Medical Center
  • Baguio City, Philippines
    • Recruiting
    • Baguio General Hospital and Medical Center
  • Cebu, Philippines
    • Recruiting
    • Cebu Doctors' University Hospital
  • Manila, Philippines
    • Recruiting
    • Manila Doctors Hospital
• Poland
  • Lublin, Poland
    • Recruiting
    • Samodzielny Publiczny Szpital Kliniczny Nr 1 w Lublinie
  • Lublin, Poland
    • Recruiting
    • Centrum Onkologii Ziemi Lubelskiej im. św. Jana z Dukli
  • Tychy, Poland
    • Recruiting
    • Szpital Miejski w Tychach
  • Warszawa, Poland
    • Recruiting
    • Narodowy Instytut Onkologii im. Marii Skłodowskiej-Curie - Państwowy Instytut Badawczy
• Portugal
  • Coimbra, Portugal
    • Recruiting
    • Centro Hospitalar e Universitário de Coimbra
  • Lisboa, Portugal
    • Recruiting
    • Fundação D. Anna de Sommer Champalimaud e Dr. Carlos Montez Champalimaud
  • Porto, Portugal
    • Recruiting
    • Instituto Português de Oncologia do Porto Francisco Gentil
• Romania
  • Baia Mare, Romania
    • Recruiting
    • Spitalul Judetean de Urgenta
  • Bucharest, Romania
    • Recruiting
    • Institutul Clinic Fundeni
  • Cluj-Napoca, Romania
    • Recruiting
    • Medisprof
  • Craiova, Romania
    • Recruiting
    • Centrul De Oncologie Sf Nectarie
  • Floreşti, Romania
    • Recruiting
    • Centrul de Radioterapie Amethyst Cluj
  • Iaşi, Romania
    • Recruiting
    • Centrul de Oncologie Euroclinic
  • Suceava, Romania
    • Recruiting
    • Clinica SIGMedical
• Serbia
  • Belgrade, Serbia
    • Recruiting
    • Institute of Oncology and Radiology of Serbia (Institut za onkologiju i radiologiju Srbije)
  • Belgrade, Serbia
    • Recruiting
    • University Hospital Medical Center (KBC) Bezanijska Kosa
  • Kragujevac, Serbia
    • Recruiting
    • Clinical Center Kragujevac
• Spain
  • Barcelona, Spain
    • Recruiting
    • Hospital Universitari Vall d'Hebron
  • Barcelona, Spain
    • Recruiting
    • Institut Català d'Oncologia - Hospital Duran i Reynals (ICO L'Hospitalet)
  • Madrid, Spain
    • Recruiting
    • Hospital General Universitario Gregorio Marañon
  • Madrid, Spain
    • Recruiting
    • Hospital Universitario Ramon Y Cajal
  • Madrid, Spain
    • Recruiting
    • Hospital Universitario HM Sanchinarro
  • Santander, Spain
    • Recruiting
    • Hospital Universitario Marqués de Valdecilla
  • Valencia, Spain
    • Recruiting
    • Hospital Clinico Universitario de Valencia
  • Zaragoza, Spain
    • Recruiting
    • Hospital Universitario Miguel Servet
• Thailand
  • Bangkok Noi, Thailand
    • Recruiting
    • Faculty of Medicine Siriraj Hospital
  • Hat Yai, Thailand
    • Recruiting
    • Songklanagarind Hospital
  • Mueang Nonthaburi, Thailand
    • Recruiting
    • Sunpasitthiprasong Hospital
• Turkey
  • Adana, Turkey
    • Recruiting
    • T.C. Saglik Bakanligi Adana Sehir Egitim ve Arastirma Hastanesi
  • Ankara, Turkey
    • Recruiting
    • Memorial Ankara Hastanesi
  • Istanbul, Turkey
    • Recruiting
    • T.C. Saglik Bakanligi - Istanbul Il Saglik Mudurlugu - Goztepe Prof. Dr. Suleyman Yalcin Sehir Hastanesi
  • Malatya, Turkey
    • Recruiting
    • İnönü Üniversitesi Turgut Özal Tıp Merkezi
  • Mamak, Turkey
    • Recruiting
    • Ankara Üniversitesi Tıp Fakültesi - Cebeci Araştırma ve Uygulama Hastanesi
  • Tuşba, Turkey
    • Recruiting
    • Van Yüzüncü Yıl Üniversitesi Dursun Odabaş Tıp Merkezi
  • Yakutiye, Turkey
    • Recruiting
    • Ataturk Universitesi Arastirma Hastanesi
  • Yüreğir, Turkey
    • Recruiting
    • Başkent Üniversitesi Adana Dr Turgut Noyan Uygulama ve Araştirma Merkezi
  • İzmit, Turkey
    • Recruiting
    • Kocaeli Üniversitesi Araştırma ve Uygulama Hastanesi
• United Kingdom
  • London, United Kingdom
    • Recruiting
    • University College London Hospitals NHS Foundation Trust
  • London, United Kingdom
    • Recruiting
    • The Royal Marsden NHS Foundation Trust
  • London, United Kingdom
    • Recruiting
    • Barts Health NHS Trust
  • London, United Kingdom
    • Recruiting
    • Sarah Cannon Research Institute London
  • Nottingham, United Kingdom
    • Recruiting
    • Quotient Sciences - Nottingham
  • Oxford, United Kingdom
    • Recruiting
    • Oxford University Hospitals NHS Foundation Trust
  • Surrey Quays, United Kingdom
    • Recruiting
    • The Royal Marsden NHS Foundation Trust
• United States
  • Arkansas
    • Hot Springs, Arkansas, United States, 71913
      • Recruiting
      • Genesis Cancer and Blood Institute
  • California
    • Los Angeles, California, United States, 90033
      • Recruiting
      • Norris Comprehensive Cancer Center
    • Los Angeles, California, United States, 90027
      • Recruiting
      • Kaiser Permanente - Los Angeles Medical Center
    • Orange, California, United States, 92868
      • Recruiting
      • University of California Irvine Health Chao Family Comprehensive Cancer Center
    • Santa Monica, California, United States, 90404
      • Recruiting
      • UCLA Health - Santa Monica Cancer Care
    • Thousand Oaks, California, United States, 91360
      • Recruiting
      • Millennium Reasearch & Clinical Development'
  • District of Columbia
    • Washington, District of Columbia, United States, 20007
      • Recruiting
      • Georgetown Lombardi Comprehensive Cancer Center
  • Florida
    • Fort Myers, Florida, United States, 33901
      • Recruiting
      • SCRI - Florida Cancer Specialists - South Region Research Office
    • Saint Petersburg, Florida, United States, 33705
      • Recruiting
      • SCRI - Florida Cancer Specialists - North Region Research Office
    • Tallahassee, Florida, United States, 32308
      • Recruiting
      • SCRI - Florida Cancer Specialists - Panhandle Research Office
    • West Palm Beach, Florida, United States, 33401
      • Recruiting
      • SCRI - Florida Cancer Specialists - East Region Research Office
  • Georgia
    • Columbus, Georgia, United States, 31904
      • Recruiting
      • Centricity Research
  • Kentucky
    • Louisville, Kentucky, United States, 40217
      • Recruiting
      • Norton Cancer Institute
    • Louisville, Kentucky, United States, 40202
      • Recruiting
      • University of Louisville James Graham Brown Cancer Center
  • Louisiana
    • New Orleans, Louisiana, United States, 70121
      • Recruiting
      • Ochsner Cancer Institute
  • Massachusetts
    • Boston, Massachusetts, United States, 02109
      • Recruiting
      • Massachusetts General Hospital
  • Michigan
    • Ann Arbor, Michigan, United States, 48109
      • Recruiting
      • University of Michigan Rogel Cancer Center
    • Detroit, Michigan, United States, 48201
      • Recruiting
      • Barbara Ann Karmanos Cancer Center
  • Minnesota
    • Saint Louis Park, Minnesota, United States, 55426
      • Recruiting
      • HealthPartners Cancer Center at Regions Hospital
  • Nebraska
    • Omaha, Nebraska, United States, 68124
      • Recruiting
      • Nebraska Cancer Specialists - Oncology Hematology West PC
  • New York
    • New York, New York, United States, 10016
      • Recruiting
      • Albert Einstein College of Medicine
    • New York, New York, United States, 10065
      • Recruiting
      • Memorial Sloan Kettering Cancer Center - New York
    • New York, New York, United States, 10012
      • Recruiting
      • NYU Langone Hospital
    • New York, New York, United States, 10029
      • Recruiting
      • Tisch Cancer Institute, Mount Sinai Hospital
  • North Carolina
    • Durham, North Carolina, United States, 27710
      • Recruiting
      • Duke University Medical Center
  • Ohio
    • Cleveland, Ohio, United States, 44106
      • Recruiting
      • University Hospitals Cleveland Medical Center
    • Columbus, Ohio, United States, 43219
      • Recruiting
      • Mark H. Zangmeister Cancer Center
  • Oregon
    • Portland, Oregon, United States, 97225
      • Recruiting
      • Providence Cancer Center Oncology and Hematology Care Westside Portland
  • South Carolina
    • Greenville, South Carolina, United States, 29615
      • Recruiting
      • Prisma Health Cancer Insitute
  • Tennessee
    • Nashville, Tennessee, United States, 37232
      • Recruiting
      • Vanderbilt - Ingram Cancer Center
    • Nashville, Tennessee, United States, 37203
      • Recruiting
      • SCRI - Tennessee Oncology - Chattanooga - Memorial Plaza
    • Nashville, Tennessee, United States, 37203
      • Recruiting
      • SCRI - Tennessee Oncology - Nashville - Centennial
  • Texas
    • Dallas, Texas, United States, 75390
      • Recruiting
      • University of Texas Southwestern Medical Center
    • Fort Worth, Texas, United States, 76104
      • Recruiting
      • The Center for Cancer & Blood Disorders - Fort Worth
    • Houston, Texas, United States, 77054
      • Recruiting
      • Dan L. Duncan Comprehensive Cancer Center at O'Quinn Medical Tower - Baylor St. Luke's Medical Center at McNair Campus
    • Houston, Texas, United States, 77054
      • Recruiting
      • Harris Health System
  • Virginia
    • Fairfax, Virginia, United States, 22031
      • Recruiting
      • USOR - Virginia Cancer Specialists - Fairfax Office
  • Washington
    • Seattle, Washington, United States, 98109
      • Recruiting
      • Fred Hutchinson Cancer Center - Seattle Cancer Care Alliance (SCCA) Location
  • Wisconsin
    • Milwaukee, Wisconsin, United States, 53226
      • Recruiting
      • Froedtert Clinical Cancer Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

• Age >= 18 years at the time of signing the informed consent.
• Capable of giving signed informed consent which is in compliance with the requirements and restrictions listed in the informed consent form (ICF) and in protocol.
• Histologically confirmed diagnosis of locally advanced unresectable or metastatic gastric, GEJ, or esophageal adenocarcinoma.
• Eastern Cooperative Oncology Group (ECOG) Performance Score of 0-1.
• At least one measurable target lesion per Response Evaluation Criteria in Solid Tumors (RECIST) v1.1.

Exclusion Criteria:

• Underlying medical or psychiatric conditions that, in the investigator's or sponsor's opinion, will make the administration of study-specified therapy hazardous, including but not limited to:

  • Interstitial lung disease, including history of interstitial lung disease or non-infectious pneumonitis. Active viral, bacterial, or fungal infections requiring parenteral treatment within 14 days of randomization.
  • Clinically significant cardiovascular disease, such as New York Heart Association Class II or greater cardiac disease or cerebrovascular accident within 3 months prior to randomization, unstable angina, or new onset angina within 3 months prior to randomization, myocardial infarction within 6 months prior to randomization, or unstable arrhythmia within 3 months prior to randomization.
  • History of prior solid-organ transplantation, including allogenic bone marrow transplantation.
  • Dementia, psychiatric, or substance abuse disorders that would interfere with satisfying the requirements of the trial.
• Known human epidermal growth factor receptor 2 (HER-2) positive tumor.
• Known untreated, symptomatic, or actively progressing central nervous system (CNS) (brain) metastases. Participants with leptomeningeal metastases are excluded from enrollment.
• Received prior systemic treatment for locally advanced unresectable or metastatic gastric, GEJ, or esophageal adenocarcinoma.
• Disease progression within 6 months of neoadjuvant or adjuvant chemotherapy.

Other protocol defined Inclusion/Exclusion criteria may apply.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Domvanalimab + Zimberelimab + FOLFOX/CAPOX (PI Choice); Participants in this arm will receive Domvanalimab and zimberelimab doses once every 4 weeks (Q4W) in addition to chemotherapy with FOLFOX (oxaliplatin, leucovorin, fluorouracil) once every 2 weeks (Q2W) or Domvanalimab and zimberelimab once every 3 weeks (Q3W) in addition to chemotherapy with CAPOX (capecitabine and oxaliplatin) Q3W.	Drug: Oxaliplatin; IV Aqueous Solution; Drug: Leucovorin; IV Aqueous Solution; Drug: Fluorouracil; IV Aqueous Solution; Drug: Capecitabine; Oral Tablets; Drug: Domvanalimab; Intravenous (IV) Aqueous Solution; Other Names: AB154; Drug: Zimberelimab; IV Aqueous Solution; Other Names: AB122
Active Comparator: Nivolumab + FOLFOX/CAPOX (PI Choice); Participants in this arm will receive Nivolumab Q2W and FOLFOX Q2W or Nivolumab Q3W + CAPOX Q3W.	Drug: Oxaliplatin; IV Aqueous Solution; Drug: Leucovorin; IV Aqueous Solution; Drug: Fluorouracil; IV Aqueous Solution; Drug: Capecitabine; Oral Tablets; Drug: Nivolumab; IV Aqueous Solution

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Overall survival	From randomization until death from any cause (Approximately 15 months)

Secondary Outcome Measures

Outcome Measure	Time Frame
Progression-free survival (PFS)	Approximately 15 months
Objective response rate (ORR)	Approximately 15 months
Duration of response (DOR)	Approximately 15 months
Incidence and severity of adverse events (AEs) and serious adverse events (SAEs)	Approximately 15 months

Collaborators and Investigators

• Sponsor: Arcus Biosciences, Inc.
• Collaborators: Gilead Sciences
• Investigators: Study Director: Medical Director, Arcus Biosciences

Study record dates

Study Major Dates

• Study Start (Actual): November 21, 2022
• Primary Completion (Estimated): September 1, 2026
• Study Completion (Estimated): January 1, 2027

Study Registration Dates

• First Submitted: October 3, 2022
• First Submitted That Met QC Criteria: October 3, 2022
• First Posted (Actual): October 5, 2022

Study Record Updates

• Last Update Posted (Actual): April 5, 2024
• Last Update Submitted That Met QC Criteria: April 4, 2024
• Last Verified: April 1, 2024

More Information

Terms related to this study

• Keywords: Nivolumab; Gastric cancer; Esophageal adenocarcinoma; Gastroesophageal junction cancer; Gastric adenocarcinoma; Zimberelimab; Domvanalimab; Advanced upper gastrointestinal tract adenocarcinoma
• Additional Relevant MeSH Terms: Neoplasms by Histologic Type; Neoplasms; Carcinoma; Neoplasms, Glandular and Epithelial; Adenocarcinoma; Physiological Effects of Drugs; Molecular Mechanisms of Pharmacological Action; Antimetabolites, Antineoplastic; Antimetabolites; Antineoplastic Agents; Immunosuppressive Agents; Immunologic Factors; Protective Agents; Antineoplastic Agents, Immunological; Micronutrients; Vitamins; Immune Checkpoint Inhibitors; Antidotes; Vitamin B Complex; Fluorouracil; Capecitabine; Oxaliplatin; Nivolumab; Leucovorin
• Other Study ID Numbers: STAR-221; 2022-002222-27 (EudraCT Number); jRCT2051220179 (Registry Identifier: Japan Registry of Clinical Trials); MOH_2023-04-30_012590 (Registry Identifier: Israel Clinical Research Site - MyTrials); CTR20233469 (Registry Identifier: China: Drug Clinical Trial Registration and Information Disclosure Platform); CTR20233470 (Registry Identifier: China: Drug Clinical Trial Registration and Information Disclosure Platform); 2023-507522-16-00 (Other Identifier: EMA: Clinical Trials Information System (CTIS))

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES

IPD Plan Description

Arcus will provide access to individual de-identified participant data and related study documents [e.g. protocol, Statistical Analysis Plan (SAP), Clinical Study Report (CSR)] upon request from qualified researchers, and subject to certain criteria, conditions, and exceptions.

For more information, please visit our website.

• IPD Sharing Supporting Information Type: STUDY_PROTOCOL; SAP; CSR

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No