A Safety and Efficacy Study of Treatment Combinations With and Without Chemotherapy in Adult Participants With Advanced Upper Gastrointestinal Tract Malignancies

Last updated: March 18, 2025
Sponsor: Arcus Biosciences, Inc.
Overall Status: Active - Not Recruiting

Phase

2

Condition

Neoplasms

Treatment

Fluorouracil

Oxaliplatin

Domvanalimab

Clinical Study ID

NCT05329766
ARC-21
2021-006291-16
  • Ages > 18
  • All Genders

Study Summary

The purpose of this study is to evaluate the safety and preliminary clinical activity of treatment combinations with and without chemotherapy in participants with locally advanced unresectable or metastatic gastric, GEJ, and esophageal adenocarcinoma. Chemotherapy will consist of FOLFOX (oxaliplatin, leucovorin, fluorouracil).

Eligibility Criteria

Inclusion

Key Inclusion Criteria:

  • Participants with histologically confirmed diagnosis of locally advancedunresectable or metastatic gastric, GEJ, or esophageal adenocarcinoma with lifeexpectancy ≥3 months as assessed by the Investigator

  • Eastern cooperative oncology group (ECOG) Performance Score of 0-1

  • At least one measurable target lesion per RECIST v1.1.

  • Adequate organ and marrow function

  • Able to provide an archival tumor sample that is representative of the cancer underinvestigation and suitable for central PD-L1 testing

Exclusion

Key Exclusion Criteria:

  • Participants with underlying medical conditions that, in the Investigator's orSponsor's opinion, will make the administration of investigational productshazardous

  • Only for Cohort A: Known Human Epidermal Growth Factor Receptor 2 (HER-2) positivetumor

  • Known untreated, symptomatic, or actively progressing central nervous system (brain)metastases. Participants with leptomeningeal metastases are excluded fromenrollment.

  • Discontinued use of prior immune checkpoint therapy due to immune related adverseevents; received prior treatment with an anti-TIGIT monoclonal antibody.

  • History of trauma or major surgery within 28 days prior to enrollment.

Note: Other protocol defined Inclusion/Exclusion criteria may apply.

Study Design

Total Participants: 333
Treatment Group(s): 6
Primary Treatment: Fluorouracil
Phase: 2
Study Start date:
June 10, 2022
Estimated Completion Date:
June 30, 2027

Connect with a study center

  • CORI Centro Oncológico Riojano Integral

    La Rioja,
    Argentina

    Site Not Available

  • UHN - Princess Margaret Cancer Centre

    Toronto,
    Canada

    Site Not Available

  • Clínica San Carlos de Apoquindo

    Las Condes,
    Chile

    Site Not Available

  • Bradford Hill Centro de Investigaciones Clinicas

    Recoleta,
    Chile

    Site Not Available

  • Centro de Estudios Clínicos SAGA

    Santiago,
    Chile

    Site Not Available

  • Clínica Universidad Católica del Maule

    Talca,
    Chile

    Site Not Available

  • Institut Bergonié

    Bordeaux,
    France

    Active - Recruiting

  • Institut Bergonié _ Bordeaux

    Bordeaux,
    France

    Site Not Available

  • CHU de Brest_Brest

    Brest,
    France

    Site Not Available

  • Centre Baclesse - CAEN

    Caen,
    France

    Site Not Available

  • Centre François Baclesse

    Caen,
    France

    Active - Recruiting

  • Centre Baclesse - CAEN

    Caen Cedex 5,
    France

    Site Not Available

  • Centre Oscar Lambret

    Lille,
    France

    Active - Recruiting

  • Centre Oscar Lambret _ LILLE

    Lille,
    France

    Site Not Available

  • Centre Oscar Lambret _ LILLE

    Lille Cedex,
    France

    Site Not Available

  • Centre Léon Bérard

    Lyon,
    France

    Active - Recruiting

  • Centre Léon Bérard _ Lyon

    Lyon,
    France

    Site Not Available

  • Hôpital Timone

    Marseille,
    France

    Active - Recruiting

  • Hôpital Timone - Marseille

    Marseille,
    France

    Site Not Available

  • Institut de Recherche en Cancerologie de Montpellier

    Montpellier,
    France

    Site Not Available

  • Institut de Recherche en Cancerologie de Montpellier

    Montpellier Cedex 5,
    France

    Site Not Available

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

    Plerin,
    France

    Site Not Available

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

    Plérin,
    France

    Site Not Available

  • Pôle Régional de Cancérologie - Service d'Oncologie Médicale - Poitiers

    Poitiers,
    France

    Site Not Available

  • Centre Henri Becquerel

    Rouen,
    France

    Active - Recruiting

  • Centre Henri Becquerel - Rouen

    Rouen,
    France

    Site Not Available

  • CHU de Toulouse_Oncopole

    Toulouse,
    France

    Site Not Available

  • CHU de Toulouse_Oncopole

    Toulouse Cedex 9,
    France

    Site Not Available

  • Gustave Roussy - Villejuif

    Villejuif,
    France

    Site Not Available

  • Dong-A University Hospital

    Busan,
    Korea, Republic of

    Site Not Available

  • Kyungpook National University Chilgok Hospital

    Daegu,
    Korea, Republic of

    Site Not Available

  • Chungnam National University Hospital

    Daejeon,
    Korea, Republic of

    Site Not Available

  • Chonnam National University Hwasun Hospital

    Hwasun,
    Korea, Republic of

    Site Not Available

  • Chungnam National University Hospital

    Junggu,
    Korea, Republic of

    Site Not Available

  • CHA Bundang Medical Center

    Seongnam,
    Korea, Republic of

    Site Not Available

  • CHA Bundang Medical Center

    Seongnam-si,
    Korea, Republic of

    Site Not Available

  • Asan Medical Center Hospital

    Seoul,
    Korea, Republic of

    Site Not Available

  • Korea University Anam Hospital

    Seoul,
    Korea, Republic of

    Site Not Available

  • Korea University Guro Hospital

    Seoul,
    Korea, Republic of

    Site Not Available

  • Samsung Medical Center

    Seoul,
    Korea, Republic of

    Site Not Available

  • Seoul National University Hospital

    Seoul,
    Korea, Republic of

    Site Not Available

  • Severance Hospital Cancer Center

    Seoul,
    Korea, Republic of

    Site Not Available

  • The Catholic University of Korea Seoul Saint Mary's Hospital

    Seoul,
    Korea, Republic of

    Active - Recruiting

  • Ajou University Hospital

    Suwon,
    Korea, Republic of

    Site Not Available

  • St. Vincent's Hospital, The Catholic University of Korea

    Suwon,
    Korea, Republic of

    Site Not Available

  • St. Vincent's Hospital, The Catholic University of Korea

    Suwon-si,
    Korea, Republic of

    Site Not Available

  • MSB - Medicinski Sistem Beograd

    Belgrad,
    Serbia

    Active - Recruiting

  • University Clinical Center of Serbia

    Belgrad,
    Serbia

    Site Not Available

  • MSB - Medicinski Sistem Beograd

    Belgrade,
    Serbia

    Site Not Available

  • University Clinical Center of Serbia

    Belgrade,
    Serbia

    Site Not Available

  • University Hospital Medical Center (KBC) Bezanijska Kosa

    Belgrade,
    Serbia

    Site Not Available

  • Clinical Center Kragujevac

    Kragujevac,
    Serbia

    Site Not Available

  • Institute of Oncology of Vojvodina

    Sremska Kamenica,
    Serbia

    Site Not Available

  • Mayo Clinic

    Phoenix, Arizona 85054
    United States

    Active - Recruiting

  • Mayo Clinic - Arizona

    Phoenix, Arizona 85054
    United States

    Site Not Available

  • USC/Norris Comprehensive Cancer Center

    Los Angeles, California 90033
    United States

    Site Not Available

  • Ronald Reagan UCLA Medical Center

    Santa Monica, California 90024
    United States

    Site Not Available

  • Yale Cancer Center

    Derby, Connecticut 06418
    United States

    Site Not Available

  • Florida Cancer Specialist - North

    Fort Myers, Florida 33901
    United States

    Active - Recruiting

  • Florida Cancer Specialist - South

    Fort Myers, Florida 33901
    United States

    Site Not Available

  • SCRI - Florida Cancer Specialists - North Region Research Office

    Fort Myers, Florida 33901
    United States

    Active - Recruiting

  • Mayo Clinic - Jacksonville

    Jacksonville, Florida 32224
    United States

    Site Not Available

  • Florida Cancer Specialist - North

    Saint Petersburg, Florida 33705
    United States

    Site Not Available

  • Florida Cancer Specialist - South

    Saint Petersburg, Florida 33705
    United States

    Active - Recruiting

  • SCRI - Florida Cancer Specialists - South Region Research Office

    Saint Petersburg, Florida 33705
    United States

    Active - Recruiting

  • Investigational site

    Sarasota, Florida 34232
    United States

    Site Not Available

  • Massachusetts General Hospital

    Boston, Massachusetts 02109
    United States

    Site Not Available

  • Roswell Park Comprehensive Cancer Center

    Buffalo, New York 14203
    United States

    Site Not Available

  • Columbia University

    New York, New York 10032
    United States

    Site Not Available

  • Memorial Sloan Kettering Cancer Center

    New York, New York 10021-0005
    United States

    Site Not Available

  • Duke University

    Durham, North Carolina 27710
    United States

    Site Not Available

  • Gabrail Cancer Center

    Canton, Ohio 44718
    United States

    Site Not Available

  • Zangmeister Cancer Center

    Columbus, Ohio 43219
    United States

    Site Not Available

  • OU - Stephenson Cancer Center

    Oklahoma City, Oklahoma 73104
    United States

    Site Not Available

  • Providence Cancer Center Oncology and Hematology Care Westside Portland

    Portland, Oregon 97225-6784
    United States

    Active - Recruiting

  • Providence Cancer Institute Franz Clinic

    Portland, Oregon 97213
    United States

    Site Not Available

  • University of Pennsylvania

    Philadelphia, Pennsylvania 19104
    United States

    Site Not Available

  • Greenville Health System Cancer Institute (Prisma)

    Spartanburg, South Carolina 29307
    United States

    Active - Recruiting

  • Prisma Health Cancer Institute

    Spartanburg, South Carolina 29307
    United States

    Site Not Available

  • SCRI Tennessee Oncology - Nashville

    Nashville, Tennessee 37203
    United States

    Site Not Available

  • Vanderbilt-Ingram Cancer Center

    Nashville, Tennessee 37232
    United States

    Site Not Available

  • Virginia Cancer Specialists

    Fairfax, Virginia 22031
    United States

    Site Not Available

  • Virginia Cancer Specialists-Fairfax Office

    Fairfax, Virginia 22031
    United States

    Active - Recruiting

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