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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)

Primary Purpose

Advanced Upper Gastrointestinal Tract Adenocarcinoma

Status
Recruiting
Phase
Phase 3
Locations
International
Study Type
Interventional
Intervention
Domvanalimab
Zimberelimab
Capecitabine
Fluorouracil
Leucovorin
Oxaliplatin
Nivolumab
Sponsored by
Arcus Biosciences, Inc.
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Advanced Upper Gastrointestinal Tract Adenocarcinoma focused on measuring Domvanalimab, Zimberelimab, Nivolumab, Advanced upper gastrointestinal tract adenocarcinoma, Gastroesophageal junction cancer, Esophageal adenocarcinoma, Gastric cancer, Gastric adenocarcinoma

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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:

    1. 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.
    2. 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.
    3. History of prior solid-organ transplantation, including allogenic bone marrow transplantation.
    4. 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.

Sites / Locations

  • Genesis Cancer and Blood InstituteRecruiting
  • Kaiser Permanente - Los Angeles Medical CenterRecruiting
  • Norris Comprehensive Cancer CenterRecruiting
  • University of California Irvine Health Chao Family Comprehensive Cancer CenterRecruiting
  • UCLA Health - Santa Monica Cancer CareRecruiting
  • Millennium Reasearch & Clinical Development'Recruiting
  • Georgetown Lombardi Comprehensive Cancer CenterRecruiting
  • SCRI - Florida Cancer Specialists - South Region Research OfficeRecruiting
  • SCRI - Florida Cancer Specialists - North Region Research OfficeRecruiting
  • SCRI - Florida Cancer Specialists - Panhandle Research OfficeRecruiting
  • SCRI - Florida Cancer Specialists - East Region Research OfficeRecruiting
  • Centricity ResearchRecruiting
  • University of Louisville James Graham Brown Cancer CenterRecruiting
  • Norton Cancer InstituteRecruiting
  • Ochsner Cancer InstituteRecruiting
  • Massachusetts General HospitalRecruiting
  • University of Michigan Rogel Cancer CenterRecruiting
  • Barbara Ann Karmanos Cancer CenterRecruiting
  • HealthPartners Cancer Center at Regions HospitalRecruiting
  • Nebraska Cancer Specialists - Oncology Hematology West PCRecruiting
  • NYU Langone HospitalRecruiting
  • Albert Einstein College of MedicineRecruiting
  • Tisch Cancer Institute, Mount Sinai HospitalRecruiting
  • Memorial Sloan Kettering Cancer Center - New YorkRecruiting
  • Duke University Medical CenterRecruiting
  • University Hospitals Cleveland Medical CenterRecruiting
  • Mark H. Zangmeister Cancer CenterRecruiting
  • Providence Cancer Center Oncology and Hematology Care Westside PortlandRecruiting
  • Prisma Health Cancer InsituteRecruiting
  • SCRI - Tennessee Oncology - Chattanooga - Memorial PlazaRecruiting
  • SCRI - Tennessee Oncology - Nashville - CentennialRecruiting
  • Vanderbilt - Ingram Cancer CenterRecruiting
  • University of Texas Southwestern Medical CenterRecruiting
  • The Center for Cancer & Blood Disorders - Fort WorthRecruiting
  • USOR - Virginia Cancer Specialists - Fairfax OfficeRecruiting
  • Monash UniversityRecruiting
  • Gosford HospitalRecruiting
  • Liverpool HospitalRecruiting
  • Oncology West - MurdochRecruiting
  • Fundação Pio XII - Hospital de Câncer de Barretos - Hospital de AmorRecruiting
  • ONCOSITE - Centro de Pesquisa Clinica Em Oncologia Ltda.Recruiting
  • Queen Elizabeth II Health Sciences Centre-Victoria GeneralRecruiting
  • Hôpital Notre-DameRecruiting
  • Princess Margaret Cancer CentreRecruiting
  • IcegclinicRecruiting
  • Oncovida - SantiagoRecruiting
  • Hospital Puerto MonttRecruiting
  • Bradford Hill Centro de Investigaciones Clinicas1Recruiting
  • Centro de Estudios Clínicos SAGARecruiting
  • Pontificia Universidad Catolica de Chile - Escuela De Medicina - Clinica UC San Carlos de ApoqRecruiting
  • Clínica Universidad Católica del Maule - TalcaRecruiting
  • Institut BergoniéRecruiting
  • Hôpital Claude HuriezRecruiting
  • Faculty of Medicine Siriraj HospitalRecruiting
  • Hôpital de la TimoneRecruiting
  • Centre Armoricain de Radiothérapie, d?Imagerie Médicale et d?OncologieRecruiting
  • Centre Hospitalier Universitaire de PoitiersRecruiting
  • Institut Gustave RoussyRecruiting
  • Evex Hospitals - Kutaisi Referral HospitalRecruiting
  • LLC Todua ClinicRecruiting
  • Ltd Tbilisi State Medical University and Ingorokva High Medical Technology University ClinicRecruiting
  • Multi-profile Clinic "New Hospitals"Recruiting
  • New Vision University HospitalRecruiting
  • Evgenidion Clinic SA - Agia TriasRecruiting
  • General Oncology Hospital of Kifisias "Agioi Anargyroi"Recruiting
  • Grupo Medico AngelesRecruiting
  • Medi-k CayaláRecruiting
  • Clínica Privada Dr. Rixci RamírezRecruiting
  • INTEGRA Cancer InstituteRecruiting
  • Centro Regional de Sub Especialidades Médicas (CRESEM) SARecruiting
  • Hong Kong Sanatorium and HospitalRecruiting
  • Tuen Mun HospitalRecruiting
  • Queen Mary Hospital (The University of Hong Kong)Recruiting
  • Humanity and Health Clinical Trial CentreRecruiting
  • Queen Mary Hospital - Hong KongRecruiting
  • Dél-pesti Centrumkórház - Országos Hematológiai és Infektológiai IntézetRecruiting
  • Országos Onkológiai IntézetRecruiting
  • Pécsi Tudományegyetem Klinikai KözpontRecruiting
  • Tel Aviv Sourasky Medical CenterRecruiting
  • Azienda Ospedaliero Universitaria Careggi-S.O.D. Patologia MedicaRecruiting
  • Instituto Europeo di OncologiaRecruiting
  • Istituto di Ricovero e Cura a Carattere Scientifico (IRCCS) - Ospedale San RaffaeleRecruiting
  • Istituto di Ricovero e Cura a Carattere Scientifico (IRCCS) - Istituto Clinico HumanitasRecruiting
  • Azienda Sanitaria Universitaria Friuli Centrale ? P.O. Santa Maria della MisericordiaRecruiting
  • Hyogo Cancer CenterRecruiting
  • Tokyo Metropolitan Cancer and Infectious Diseases Center Komagome HospitalRecruiting
  • National Cancer Center - Kashiwa CampusRecruiting
  • St. Marianna University HospitalRecruiting
  • Cancer Institute Hospital of JFCRRecruiting
  • Aichi Cancer CenterRecruiting
  • Osaka Prefectural Hospital Organization - Osaka International Cancer InstituteRecruiting
  • National Cancer Center HospitalRecruiting
  • Kindai University HospitalRecruiting
  • Gunma Prefectural Cancer CenterRecruiting
  • Dong-A University HospitalRecruiting
  • Severance HospitalRecruiting
  • Kauno KlinikosRecruiting
  • Klaipedos Universitetine LigonineRecruiting
  • Nacionalinis Vėžio InstitutasRecruiting
  • Vilniaus Universiteto Ligoninė Santariškių KlinikosRecruiting
  • Hospital Pulau PinangRecruiting
  • Hospital Kuala LumpurRecruiting
  • Pusat Perubatan Universiti MalayaRecruiting
  • Hospital Umum SarawakRecruiting
  • Instituto Nacional de Cancerologia - MexicoRecruiting
  • CLIMERS Clinical Medical ResearchRecruiting
  • Centro Especializado en Investigacion y Tratamiento Oncologicos SCRecruiting
  • Centro de Atención e Investigación Clínica en OncologíaRecruiting
  • Hospital Zambrano Hellion TecSaludRecruiting
  • Centro Hemato - Oncológico Privado (CHOP)Recruiting
  • Dr Pablo O. Torre Memorial Hospital - Riverside Medical CenterRecruiting
  • Baguio General Hospital and Medical CenterRecruiting
  • Baguio General Hospital and Medical CenterRecruiting
  • Cebu Doctors' University HospitalRecruiting
  • Manila Doctors HospitalRecruiting
  • Centro Hospitalar e Universitário de CoimbraRecruiting
  • Fundação D. Anna de Sommer Champalimaud e Dr. Carlos Montez ChampalimaudRecruiting
  • Instituto Português de Oncologia do Porto Francisco GentilRecruiting
  • Spitalul Judetean de UrgentaRecruiting
  • Institutul Clinic FundeniRecruiting
  • MedisprofRecruiting
  • Centrul De Oncologie Sf NectarieRecruiting
  • Centrul de Radioterapie Amethyst ClujRecruiting
  • Centrul de Oncologie EuroclinicRecruiting
  • Institute of Oncology and Radiology of Serbia (Institut za onkologiju i radiologiju Srbije)Recruiting
  • University Hospital Medical Center (KBC) Bezanijska KosaRecruiting
  • Clinical Center KragujevacRecruiting
  • Hospital Universitari Vall d'HebrónRecruiting
  • Hospital Universitario HM SanchinarroRecruiting
  • Hospital Universitario Ramón y CajalRecruiting
  • Hospital Universitario Marqués de ValdecillaRecruiting
  • Hospital Clínico Universitario de ValenciaRecruiting
  • Sunpasitthiprasong HospitalRecruiting
  • Barts Health NHS TrustRecruiting
  • Sarah Cannon Research Institute LondonRecruiting
  • University College London Hospitals NHS Foundation TrustRecruiting
  • Oxford University Hospitals NHS Foundation TrustRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Domvanalimab + Zimberelimab + FOLFOX/CAPOX (PI Choice)

Nivolumab + FOLFOX/CAPOX (PI Choice)

Arm Description

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.

Participants in this arm will receive Nivolumab Q2W and FOLFOX Q2W or Nivolumab Q3W + CAPOX Q3W.

Outcomes

Primary Outcome Measures

Overall survival

Secondary Outcome Measures

Progression-free survival (PFS)
Objective response rate (ORR)
Duration of response (DOR)
Incidence and severity of adverse events (AEs) and serious adverse events (SAEs)

Full Information

First Posted
October 3, 2022
Last Updated
October 3, 2023
Sponsor
Arcus Biosciences, Inc.
Collaborators
Gilead Sciences
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1. Study Identification

Unique Protocol Identification Number
NCT05568095
Brief Title
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
Acronym
STAR-221
Official Title
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
Study Type
Interventional

2. Study Status

Record Verification Date
October 2023
Overall Recruitment Status
Recruiting
Study Start Date
November 21, 2022 (Actual)
Primary Completion Date
September 2026 (Anticipated)
Study Completion Date
January 2027 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Arcus Biosciences, Inc.
Collaborators
Gilead Sciences

4. Oversight

Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

Brief Summary
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Advanced Upper Gastrointestinal Tract Adenocarcinoma
Keywords
Domvanalimab, Zimberelimab, Nivolumab, Advanced upper gastrointestinal tract adenocarcinoma, Gastroesophageal junction cancer, Esophageal adenocarcinoma, Gastric cancer, Gastric adenocarcinoma

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
970 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Domvanalimab + Zimberelimab + FOLFOX/CAPOX (PI Choice)
Arm Type
Experimental
Arm Description
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.
Arm Title
Nivolumab + FOLFOX/CAPOX (PI Choice)
Arm Type
Active Comparator
Arm Description
Participants in this arm will receive Nivolumab Q2W and FOLFOX Q2W or Nivolumab Q3W + CAPOX Q3W.
Intervention Type
Drug
Intervention Name(s)
Domvanalimab
Other Intervention Name(s)
AB154
Intervention Description
Intravenous (IV) Aqueous Solution
Intervention Type
Drug
Intervention Name(s)
Zimberelimab
Other Intervention Name(s)
AB122
Intervention Description
IV Aqueous Solution
Intervention Type
Drug
Intervention Name(s)
Capecitabine
Intervention Description
Oral Tablets
Intervention Type
Drug
Intervention Name(s)
Fluorouracil
Intervention Description
IV Aqueous Solution
Intervention Type
Drug
Intervention Name(s)
Leucovorin
Intervention Description
IV Aqueous Solution
Intervention Type
Drug
Intervention Name(s)
Oxaliplatin
Intervention Description
IV Aqueous Solution
Intervention Type
Drug
Intervention Name(s)
Nivolumab
Intervention Description
IV Aqueous Solution
Primary Outcome Measure Information:
Title
Overall survival
Time Frame
From randomization until death from any cause (Approximately 15 months)
Secondary Outcome Measure Information:
Title
Progression-free survival (PFS)
Time Frame
Approximately 15 months
Title
Objective response rate (ORR)
Time Frame
Approximately 15 months
Title
Duration of response (DOR)
Time Frame
Approximately 15 months
Title
Incidence and severity of adverse events (AEs) and serious adverse events (SAEs)
Time Frame
Approximately 15 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Medical Director
Phone
+1-510-462-3330
Email
ClinicalTrials@arcusbio.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Medical Director
Organizational Affiliation
Arcus Biosciences
Official's Role
Study Director
Facility Information:
Facility Name
Genesis Cancer and Blood Institute
City
Hot Springs
State/Province
Arkansas
ZIP/Postal Code
71913
Country
United States
Individual Site Status
Recruiting
Facility Name
Kaiser Permanente - Los Angeles Medical Center
City
Los Angeles
State/Province
California
ZIP/Postal Code
90027
Country
United States
Individual Site Status
Recruiting
Facility Name
Norris Comprehensive Cancer Center
City
Los Angeles
State/Province
California
ZIP/Postal Code
90033
Country
United States
Individual Site Status
Recruiting
Facility Name
University of California Irvine Health Chao Family Comprehensive Cancer Center
City
Orange
State/Province
California
ZIP/Postal Code
92868
Country
United States
Individual Site Status
Recruiting
Facility Name
UCLA Health - Santa Monica Cancer Care
City
Santa Monica
State/Province
California
ZIP/Postal Code
90404
Country
United States
Individual Site Status
Recruiting
Facility Name
Millennium Reasearch & Clinical Development'
City
Thousand Oaks
State/Province
California
ZIP/Postal Code
91360
Country
United States
Individual Site Status
Recruiting
Facility Name
Georgetown Lombardi Comprehensive Cancer Center
City
Washington
State/Province
District of Columbia
ZIP/Postal Code
20007
Country
United States
Individual Site Status
Recruiting
Facility Name
SCRI - Florida Cancer Specialists - South Region Research Office
City
Fort Myers
State/Province
Florida
ZIP/Postal Code
33901
Country
United States
Individual Site Status
Recruiting
Facility Name
SCRI - Florida Cancer Specialists - North Region Research Office
City
Saint Petersburg
State/Province
Florida
ZIP/Postal Code
33705
Country
United States
Individual Site Status
Recruiting
Facility Name
SCRI - Florida Cancer Specialists - Panhandle Research Office
City
Tallahassee
State/Province
Florida
ZIP/Postal Code
32308
Country
United States
Individual Site Status
Recruiting
Facility Name
SCRI - Florida Cancer Specialists - East Region Research Office
City
West Palm Beach
State/Province
Florida
ZIP/Postal Code
33401
Country
United States
Individual Site Status
Recruiting
Facility Name
Centricity Research
City
Columbus
State/Province
Georgia
ZIP/Postal Code
31904
Country
United States
Individual Site Status
Recruiting
Facility Name
University of Louisville James Graham Brown Cancer Center
City
Louisville
State/Province
Kentucky
ZIP/Postal Code
40202
Country
United States
Individual Site Status
Recruiting
Facility Name
Norton Cancer Institute
City
Louisville
State/Province
Kentucky
ZIP/Postal Code
40217
Country
United States
Individual Site Status
Recruiting
Facility Name
Ochsner Cancer Institute
City
New Orleans
State/Province
Louisiana
ZIP/Postal Code
70121
Country
United States
Individual Site Status
Recruiting
Facility Name
Massachusetts General Hospital
City
Boston
State/Province
Massachusetts
ZIP/Postal Code
02109
Country
United States
Individual Site Status
Recruiting
Facility Name
University of Michigan Rogel Cancer Center
City
Ann Arbor
State/Province
Michigan
ZIP/Postal Code
48109
Country
United States
Individual Site Status
Recruiting
Facility Name
Barbara Ann Karmanos Cancer Center
City
Detroit
State/Province
Michigan
ZIP/Postal Code
48201
Country
United States
Individual Site Status
Recruiting
Facility Name
HealthPartners Cancer Center at Regions Hospital
City
Saint Louis Park
State/Province
Minnesota
ZIP/Postal Code
55426
Country
United States
Individual Site Status
Recruiting
Facility Name
Nebraska Cancer Specialists - Oncology Hematology West PC
City
Omaha
State/Province
Nebraska
ZIP/Postal Code
68124
Country
United States
Individual Site Status
Recruiting
Facility Name
NYU Langone Hospital
City
New York
State/Province
New York
ZIP/Postal Code
10012
Country
United States
Individual Site Status
Recruiting
Facility Name
Albert Einstein College of Medicine
City
New York
State/Province
New York
ZIP/Postal Code
10016
Country
United States
Individual Site Status
Recruiting
Facility Name
Tisch Cancer Institute, Mount Sinai Hospital
City
New York
State/Province
New York
ZIP/Postal Code
10029
Country
United States
Individual Site Status
Recruiting
Facility Name
Memorial Sloan Kettering Cancer Center - New York
City
New York
State/Province
New York
ZIP/Postal Code
10065
Country
United States
Individual Site Status
Recruiting
Facility Name
Duke University Medical Center
City
Durham
State/Province
North Carolina
ZIP/Postal Code
27710
Country
United States
Individual Site Status
Recruiting
Facility Name
University Hospitals Cleveland Medical Center
City
Cleveland
State/Province
Ohio
ZIP/Postal Code
44106
Country
United States
Individual Site Status
Recruiting
Facility Name
Mark H. Zangmeister Cancer Center
City
Columbus
State/Province
Ohio
ZIP/Postal Code
43219
Country
United States
Individual Site Status
Recruiting
Facility Name
Providence Cancer Center Oncology and Hematology Care Westside Portland
City
Portland
State/Province
Oregon
ZIP/Postal Code
97225
Country
United States
Individual Site Status
Recruiting
Facility Name
Prisma Health Cancer Insitute
City
Greenville
State/Province
South Carolina
ZIP/Postal Code
29615
Country
United States
Individual Site Status
Recruiting
Facility Name
SCRI - Tennessee Oncology - Chattanooga - Memorial Plaza
City
Nashville
State/Province
Tennessee
ZIP/Postal Code
37203
Country
United States
Individual Site Status
Recruiting
Facility Name
SCRI - Tennessee Oncology - Nashville - Centennial
City
Nashville
State/Province
Tennessee
ZIP/Postal Code
37203
Country
United States
Individual Site Status
Recruiting
Facility Name
Vanderbilt - Ingram Cancer Center
City
Nashville
State/Province
Tennessee
ZIP/Postal Code
37232
Country
United States
Individual Site Status
Recruiting
Facility Name
University of Texas Southwestern Medical Center
City
Dallas
State/Province
Texas
ZIP/Postal Code
75390
Country
United States
Individual Site Status
Recruiting
Facility Name
The Center for Cancer & Blood Disorders - Fort Worth
City
Fort Worth
State/Province
Texas
ZIP/Postal Code
76104
Country
United States
Individual Site Status
Recruiting
Facility Name
USOR - Virginia Cancer Specialists - Fairfax Office
City
Fairfax
State/Province
Virginia
ZIP/Postal Code
22031
Country
United States
Individual Site Status
Recruiting
Facility Name
Monash University
City
Clayton
Country
Australia
Individual Site Status
Recruiting
Facility Name
Gosford Hospital
City
Gosford
Country
Australia
Individual Site Status
Recruiting
Facility Name
Liverpool Hospital
City
Liverpool
Country
Australia
Individual Site Status
Recruiting
Facility Name
Oncology West - Murdoch
City
Murdoch
Country
Australia
Individual Site Status
Recruiting
Facility Name
Fundação Pio XII - Hospital de Câncer de Barretos - Hospital de Amor
City
Barretos
Country
Brazil
Individual Site Status
Recruiting
Facility Name
ONCOSITE - Centro de Pesquisa Clinica Em Oncologia Ltda.
City
Ijuí
Country
Brazil
Individual Site Status
Recruiting
Facility Name
Queen Elizabeth II Health Sciences Centre-Victoria General
City
Charlottetown
Country
Canada
Individual Site Status
Recruiting
Facility Name
Hôpital Notre-Dame
City
Québec
Country
Canada
Individual Site Status
Recruiting
Facility Name
Princess Margaret Cancer Centre
City
Toronto
Country
Canada
Individual Site Status
Recruiting
Facility Name
Icegclinic
City
La Florida
Country
Chile
Individual Site Status
Recruiting
Facility Name
Oncovida - Santiago
City
Providencia
Country
Chile
Individual Site Status
Recruiting
Facility Name
Hospital Puerto Montt
City
Puerto Montt
Country
Chile
Individual Site Status
Recruiting
Facility Name
Bradford Hill Centro de Investigaciones Clinicas1
City
Recoleta
Country
Chile
Individual Site Status
Recruiting
Facility Name
Centro de Estudios Clínicos SAGA
City
Santiago
Country
Chile
Individual Site Status
Recruiting
Facility Name
Pontificia Universidad Catolica de Chile - Escuela De Medicina - Clinica UC San Carlos de Apoq
City
Santiago
Country
Chile
Individual Site Status
Recruiting
Facility Name
Clínica Universidad Católica del Maule - Talca
City
Talca
Country
Chile
Individual Site Status
Recruiting
Facility Name
Institut Bergonié
City
Bordeaux
Country
France
Individual Site Status
Recruiting
Facility Name
Hôpital Claude Huriez
City
Lille
Country
France
Individual Site Status
Recruiting
Facility Name
Faculty of Medicine Siriraj Hospital
City
Lyon
Country
France
Individual Site Status
Recruiting
Facility Name
Hôpital de la Timone
City
Marseille
Country
France
Individual Site Status
Recruiting
Facility Name
Centre Armoricain de Radiothérapie, d?Imagerie Médicale et d?Oncologie
City
Plérin
Country
France
Individual Site Status
Recruiting
Facility Name
Centre Hospitalier Universitaire de Poitiers
City
Poitiers
Country
France
Individual Site Status
Recruiting
Facility Name
Institut Gustave Roussy
City
Villejuif
Country
France
Individual Site Status
Recruiting
Facility Name
Evex Hospitals - Kutaisi Referral Hospital
City
Kutaisi
Country
Georgia
Individual Site Status
Recruiting
Facility Name
LLC Todua Clinic
City
Tbilisi
Country
Georgia
Individual Site Status
Recruiting
Facility Name
Ltd Tbilisi State Medical University and Ingorokva High Medical Technology University Clinic
City
Tbilisi
Country
Georgia
Individual Site Status
Recruiting
Facility Name
Multi-profile Clinic "New Hospitals"
City
Tbilisi
Country
Georgia
Individual Site Status
Recruiting
Facility Name
New Vision University Hospital
City
Tbilisi
Country
Georgia
Individual Site Status
Recruiting
Facility Name
Evgenidion Clinic SA - Agia Trias
City
Athens
Country
Greece
Individual Site Status
Recruiting
Facility Name
General Oncology Hospital of Kifisias "Agioi Anargyroi"
City
Néa Kifisiá
Country
Greece
Individual Site Status
Recruiting
Facility Name
Grupo Medico Angeles
City
Guatemala city
Country
Guatemala
Individual Site Status
Recruiting
Facility Name
Medi-k Cayalá
City
Guatemala city
Country
Guatemala
Individual Site Status
Recruiting
Facility Name
Clínica Privada Dr. Rixci Ramírez
City
Guatemala
Country
Guatemala
Individual Site Status
Recruiting
Facility Name
INTEGRA Cancer Institute
City
Guatemala
Country
Guatemala
Individual Site Status
Recruiting
Facility Name
Centro Regional de Sub Especialidades Médicas (CRESEM) SA
City
Quetzaltenango
Country
Guatemala
Individual Site Status
Recruiting
Facility Name
Hong Kong Sanatorium and Hospital
City
Happy Valley
Country
Hong Kong
Individual Site Status
Recruiting
Facility Name
Tuen Mun Hospital
City
Happy Valley
Country
Hong Kong
Individual Site Status
Recruiting
Facility Name
Queen Mary Hospital (The University of Hong Kong)
City
Hong Kong
ZIP/Postal Code
999077
Country
Hong Kong
Individual Site Status
Recruiting
Facility Name
Humanity and Health Clinical Trial Centre
City
Hong Kong
Country
Hong Kong
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Chi Pan Lau
Facility Name
Queen Mary Hospital - Hong Kong
City
Hong Kong
Country
Hong Kong
Individual Site Status
Recruiting
Facility Name
Dél-pesti Centrumkórház - Országos Hematológiai és Infektológiai Intézet
City
Budapest
Country
Hungary
Individual Site Status
Recruiting
Facility Name
Országos Onkológiai Intézet
City
Budapest
Country
Hungary
Individual Site Status
Recruiting
Facility Name
Pécsi Tudományegyetem Klinikai Központ
City
Pécs
Country
Hungary
Individual Site Status
Recruiting
Facility Name
Tel Aviv Sourasky Medical Center
City
Tel Aviv
Country
Israel
Individual Site Status
Recruiting
Facility Name
Azienda Ospedaliero Universitaria Careggi-S.O.D. Patologia Medica
City
Firenze
ZIP/Postal Code
50134
Country
Italy
Individual Site Status
Recruiting
Facility Name
Instituto Europeo di Oncologia
City
Milano
ZIP/Postal Code
20141
Country
Italy
Individual Site Status
Recruiting
Facility Name
Istituto di Ricovero e Cura a Carattere Scientifico (IRCCS) - Ospedale San Raffaele
City
Milan
Country
Italy
Individual Site Status
Recruiting
Facility Name
Istituto di Ricovero e Cura a Carattere Scientifico (IRCCS) - Istituto Clinico Humanitas
City
Rozzano
Country
Italy
Individual Site Status
Recruiting
Facility Name
Azienda Sanitaria Universitaria Friuli Centrale ? P.O. Santa Maria della Misericordia
City
Udine
Country
Italy
Individual Site Status
Recruiting
Facility Name
Hyogo Cancer Center
City
Akashi
Country
Japan
Individual Site Status
Recruiting
Facility Name
Tokyo Metropolitan Cancer and Infectious Diseases Center Komagome Hospital
City
Bunkyō-Ku
Country
Japan
Individual Site Status
Recruiting
Facility Name
National Cancer Center - Kashiwa Campus
City
Kashiwa
Country
Japan
Individual Site Status
Recruiting
Facility Name
St. Marianna University Hospital
City
Kawasaki
Country
Japan
Individual Site Status
Recruiting
Facility Name
Cancer Institute Hospital of JFCR
City
Koto-Ku
Country
Japan
Individual Site Status
Recruiting
Facility Name
Aichi Cancer Center
City
Nagoya
Country
Japan
Individual Site Status
Recruiting
Facility Name
Osaka Prefectural Hospital Organization - Osaka International Cancer Institute
City
Osaka
Country
Japan
Individual Site Status
Recruiting
Facility Name
National Cancer Center Hospital
City
Tokyo
Country
Japan
Individual Site Status
Recruiting
Facility Name
Kindai University Hospital
City
Ōsaka-sayama
Country
Japan
Individual Site Status
Recruiting
Facility Name
Gunma Prefectural Cancer Center
City
Ōta
Country
Japan
Individual Site Status
Recruiting
Facility Name
Dong-A University Hospital
City
Busan
Country
Korea, Republic of
Individual Site Status
Recruiting
Facility Name
Severance Hospital
City
Seoul
Country
Korea, Republic of
Individual Site Status
Recruiting
Facility Name
Kauno Klinikos
City
Kaunas
Country
Lithuania
Individual Site Status
Recruiting
Facility Name
Klaipedos Universitetine Ligonine
City
Klaipėda
Country
Lithuania
Individual Site Status
Recruiting
Facility Name
Nacionalinis Vėžio Institutas
City
Vilnius
Country
Lithuania
Individual Site Status
Recruiting
Facility Name
Vilniaus Universiteto Ligoninė Santariškių Klinikos
City
Vilnius
Country
Lithuania
Individual Site Status
Recruiting
Facility Name
Hospital Pulau Pinang
City
George Town
Country
Malaysia
Individual Site Status
Recruiting
Facility Name
Hospital Kuala Lumpur
City
Kuala Lumpur
Country
Malaysia
Individual Site Status
Recruiting
Facility Name
Pusat Perubatan Universiti Malaya
City
Kuala Lumpur
Country
Malaysia
Individual Site Status
Recruiting
Facility Name
Hospital Umum Sarawak
City
Kuching
Country
Malaysia
Individual Site Status
Recruiting
Facility Name
Instituto Nacional de Cancerologia - Mexico
City
Ciudad de mexico
Country
Mexico
Individual Site Status
Recruiting
Facility Name
CLIMERS Clinical Medical Research
City
Colonia Centro
Country
Mexico
Individual Site Status
Recruiting
Facility Name
Centro Especializado en Investigacion y Tratamiento Oncologicos SC
City
Mexico City
Country
Mexico
Individual Site Status
Recruiting
Facility Name
Centro de Atención e Investigación Clínica en Oncología
City
Mérida
Country
Mexico
Individual Site Status
Recruiting
Facility Name
Hospital Zambrano Hellion TecSalud
City
San Pedro Garza Garcia
Country
Mexico
Individual Site Status
Recruiting
Facility Name
Centro Hemato - Oncológico Privado (CHOP)
City
Toluca
Country
Mexico
Individual Site Status
Recruiting
Facility Name
Dr Pablo O. Torre Memorial Hospital - Riverside Medical Center
City
Bacolod
Country
Philippines
Individual Site Status
Recruiting
Facility Name
Baguio General Hospital and Medical Center
City
Baguio City
Country
Philippines
Individual Site Status
Recruiting
Facility Name
Baguio General Hospital and Medical Center
City
Baguio
Country
Philippines
Individual Site Status
Recruiting
Facility Name
Cebu Doctors' University Hospital
City
Cebu
Country
Philippines
Individual Site Status
Recruiting
Facility Name
Manila Doctors Hospital
City
Manila
Country
Philippines
Individual Site Status
Recruiting
Facility Name
Centro Hospitalar e Universitário de Coimbra
City
Coimbra
Country
Portugal
Individual Site Status
Recruiting
Facility Name
Fundação D. Anna de Sommer Champalimaud e Dr. Carlos Montez Champalimaud
City
Lisboa
Country
Portugal
Individual Site Status
Recruiting
Facility Name
Instituto Português de Oncologia do Porto Francisco Gentil
City
Porto
Country
Portugal
Individual Site Status
Recruiting
Facility Name
Spitalul Judetean de Urgenta
City
Baia Mare
Country
Romania
Individual Site Status
Recruiting
Facility Name
Institutul Clinic Fundeni
City
Bucharest
Country
Romania
Individual Site Status
Recruiting
Facility Name
Medisprof
City
Cluj-Napoca
Country
Romania
Individual Site Status
Recruiting
Facility Name
Centrul De Oncologie Sf Nectarie
City
Craiova
Country
Romania
Individual Site Status
Recruiting
Facility Name
Centrul de Radioterapie Amethyst Cluj
City
Floreşti
Country
Romania
Individual Site Status
Recruiting
Facility Name
Centrul de Oncologie Euroclinic
City
Iaşi
Country
Romania
Individual Site Status
Recruiting
Facility Name
Institute of Oncology and Radiology of Serbia (Institut za onkologiju i radiologiju Srbije)
City
Belgrade
Country
Serbia
Individual Site Status
Recruiting
Facility Name
University Hospital Medical Center (KBC) Bezanijska Kosa
City
Belgrade
Country
Serbia
Individual Site Status
Recruiting
Facility Name
Clinical Center Kragujevac
City
Kragujevac
Country
Serbia
Individual Site Status
Recruiting
Facility Name
Hospital Universitari Vall d'Hebrón
City
Barcelona
Country
Spain
Individual Site Status
Recruiting
Facility Name
Hospital Universitario HM Sanchinarro
City
Madrid
Country
Spain
Individual Site Status
Recruiting
Facility Name
Hospital Universitario Ramón y Cajal
City
Madrid
Country
Spain
Individual Site Status
Recruiting
Facility Name
Hospital Universitario Marqués de Valdecilla
City
Santander
Country
Spain
Individual Site Status
Recruiting
Facility Name
Hospital Clínico Universitario de Valencia
City
Valencia
Country
Spain
Individual Site Status
Recruiting
Facility Name
Sunpasitthiprasong Hospital
City
Mueang Nonthaburi
Country
Thailand
Individual Site Status
Recruiting
Facility Name
Barts Health NHS Trust
City
London
Country
United Kingdom
Individual Site Status
Recruiting
Facility Name
Sarah Cannon Research Institute London
City
London
Country
United Kingdom
Individual Site Status
Recruiting
Facility Name
University College London Hospitals NHS Foundation Trust
City
London
Country
United Kingdom
Individual Site Status
Recruiting
Facility Name
Oxford University Hospitals NHS Foundation Trust
City
Oxford
Country
United Kingdom
Individual Site Status
Recruiting

12. IPD Sharing Statement

Plan to Share IPD
Yes
IPD Sharing 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 URL
https://trials.arcusbio.com/our-transparency-policy

Learn more about this trial

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

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