Clinical trial • Phase III • Oncology

DOMVANALIMAB for Gastric adenocarcinoma | Gastroesophageal junction adenocarcinoma | Esophageal adenocarcinoma

Phase III trial of DOMVANALIMAB for Gastric adenocarcinoma | Gastroesophageal junction adenocarcinoma | Esophageal adenocarcinoma.

Overview

Trial Therapeutic Area
Oncology
Trial Disease
Gastric adenocarcinoma | Gastroesophageal junction adenocarcinoma | Esophageal adenocarcinoma
Trial Stage
Phase III
Drug Modality
Monoclonal antibody | Small molecule

Key dates

Initial CTIS Submission Date
31-07-2024
First CTIS Authorization Date
29-08-2024

Trial design

Randomised, open-label, active comparator: nivolumab + folfox/capox (pi choice). participants in this arm will receive nivolumab q2w and folfox q2w or nivolumab q3w + capox q3w. (dose amounts not specified in provided record.)-controlled, adaptive Phase III trial in Portugal, Lithuania, Romania and others.

Randomised
Yes
Open Label
Yes
Comparator
Active Comparator: nivolumab + FOLFOX/CAPOX (PI Choice). Participants in this arm will receive nivolumab Q2W and FOLFOX Q2W or nivolumab Q3W + CAPOX Q3W. (Dose amounts not specified in provided record.)
Adaptive
True, a planned interim analysis reviewed by the Independent Data Monitoring Committee (IDMC) was performed; the IDMC recommended stopping the study after the interim analysis (IDMC meeting 09 December 2025) for futility.
Biomarker Stratified
True, PD-L1 (strata described in objectives: high PD-L1 expression; positive PD-L1 expression; all randomized participants)
Target Sample Size
563
Trial Duration For Participant
730

Eligibility

Recruits 563 isVulnerablePopulationSelected = true; participants must be capable of giving signed 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." No additional assent or surrogate consent arrangements are described in the available record..

Vulnerable Population
isVulnerablePopulationSelected = true; participants must be capable of giving signed 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." No additional assent or surrogate consent arrangements are described in the available record.

Inclusion criteria

  • {"criterion_text":"- Age >= 18 years at the time of signing the informed consent."}
  • {"criterion_text":"- 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."}
  • {"criterion_text":"- Histologically confirmed diagnosis of locally advanced unresectable or metastatic gastric, GEJ, or esophageal adenocarcinoma."}
  • {"criterion_text":"- Eastern Cooperative Oncology Group (ECOG) Performance Score of 0-1."}
  • {"criterion_text":"- At least one measurable target lesion per Response Evaluation Criteria in Solid Tumors (RECIST) v1.1."}

Exclusion criteria

  • {"criterion_text":"- 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."}
  • {"criterion_text":"- Known human epidermal growth factor receptor 2 (HER-2) positive tumor."}
  • {"criterion_text":"- Known untreated, symptomatic, or actively progressing central nervous system (CNS) (brain) metastases. Participants with leptomeningeal metastases are excluded from enrollment."}
  • {"criterion_text":"- Received prior systemic treatment for locally advanced unresectable or metastatic gastric, GEJ, or esophageal adenocarcinoma."}
  • {"criterion_text":"- Disease progression within 6 months of neoadjuvant or adjuvant chemotherapy."}

Endpoints

Primary endpoints

  • {"endpoint_text":"- OS is defined as the length of time from date of randomization until the date of death from any cause","definition_or_measurement_approach":"OS is defined as the length of time from date of randomization until the date of death from any cause."}

Secondary endpoints

  • {"endpoint_text":"- PFS is defined as the time from date of randomization until disease progression or death from any cause, whichever comes first, as measured per Response Evaluation Criteria in Solid Tumors version 1.1 (RECIST 1.1) as assessed by the investigator","definition_or_measurement_approach":"Time from date of randomization until disease progression or death, whichever occurs first, measured per RECIST v1.1 as assessed by the investigator."}
  • {"endpoint_text":"- Time to first symptom deterioration in the FACT-Ga gastric cancer subscale.","definition_or_measurement_approach":"Time to first deterioration in the FACT-Ga gastric cancer subscale."}
  • {"endpoint_text":"- Objective response rate (ORR) is defined as the proportion of participants who have achieved confirmed complete response (CR) or confirmed partial response (PR) to study therapy as assessed by the investigator according to RECIST 1.1","definition_or_measurement_approach":"Proportion of participants with confirmed CR or PR assessed by investigator per RECIST v1.1."}
  • {"endpoint_text":"- Duration of response (DOR) is measured from the time of first confirmed response (CR or PR as measured by RECIST v1.1) as assessed by the investigator, until the date of first documented disease progression or death, whichever comes first.","definition_or_measurement_approach":"Measured from first confirmed CR/PR (per RECIST v1.1) to first documented progression or death, whichever occurs first."}
  • {"endpoint_text":"- The incidence and severity of adverse events (AEs) and serious adverse events (SAEs), and any clinically meaningful trends in safety parameters","definition_or_measurement_approach":"Incidence and severity of AEs and SAEs captured and summarized; clinically meaningful trends in safety parameters evaluated."}

Recruitment

Digital Remote Recruitment
True, digital methods referenced include Scout Email Communication, Scout Study Brochure, ScoutPass Reloadable and ePRO/IRT (Signant Health) for electronic patient-reported outcomes and remote interactions.
Planned Sample Size
563
Recruitment Window Months
50
Consent Approach
Informed consent must be signed by the participant: "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." Subject information and ICF documents are available in multiple languages (English, Portuguese, Spanish, French, Greek, Hungarian, Lithuanian, Romanian, Italian, Polish, Russian and others shown in the document list). No separate assent/surrogate consent procedures are described in the available record.

Methods

  • Site-based recruitment via participating hospitals and oncology centres listed in member state Part II submissions (trial sites across France, Greece, Hungary, Italy, Lithuania, Portugal, Romania, Spain, Poland).
  • Third-party patient outreach and engagement via Scout Clinical (materials identified: Scout Email Communication, Scout Study Brochure, ScoutPass reloadable) and related 'Scout' patient-facing materials; third-party involvement for patient reimbursement.
  • Investigator/clinic-led approaches including Investigator Letters (K1 Investigator Letter documents) provided to sites.

Geography

Total Number Of Sites
Unknown
Total Number Of Participants
Unknown

Portugal

Latest Decision Or Authorization Date
21-04-2025
Number Of Sites
3
Number Of Participants
11

Sites

Site Name
Champalimaud Clinical Centre
Contact Person Name
Nuno Couto
Site Name
Instituto Portugues De Oncologia Do Porto Francisco Gentil E.P.E.
Department Name
Medical Oncology
Contact Person Name
Nuno Sousa
Site Name
Unidade Local De Saude De Coimbra E.P.E.
Department Name
Medical Oncology
Contact Person Name
Edgar Pratas
Contact Person Email
10557@chuc.min-saude.pt

Lithuania

Latest Decision Or Authorization Date
19-05-2025
Number Of Sites
4
Number Of Participants
9

Sites

Site Name
Nacionalinis vezio institutas
Department Name
Nacionalinis Vėžio Institutas
Contact Person Name
Edita Baltruskeviciene
Contact Person Email
edita.baltruskeviciene@nvi.lt
Site Name
Klaipedos universiteto ligonine VšĮ
Department Name
Klaipedos Universitetine Ligonine
Contact Person Name
Alvydas Cesas
Contact Person Email
a.cesas@kul.lt
Site Name
Vilniaus Universiteto Ligonine Santaros Klinikos Vsi
Department Name
Vilniaus Universiteto Ligoninė Santariškių Klinikos
Contact Person Name
Skaiste Tulyte
Contact Person Email
skaiste.tulyte@santa.lt
Site Name
Lietuvos sveikatos mokslu universiteto ligonine Kauno klinikos
Department Name
Kauno Klinikos
Contact Person Name
Rasa Janciauskiene

Romania

Latest Decision Or Authorization Date
28-04-2025
Number Of Sites
8
Number Of Participants
49

Sites

Site Name
Centrul De Oncologie SF Nectarie S.R.L.
Department Name
Medical Oncology
Contact Person Name
Michael Schenker
Contact Person Email
mike_schenker@yahoo.com
Site Name
Sigmedical Services S.R.L.
Department Name
Medical Oncology
Contact Person Name
Doina Elena Ganea
Contact Person Email
motan_doina@yahoo.com
Site Name
Radiotherapy Center Cluj S.R.L.
Department Name
Medical Oncology
Contact Person Name
Andrei Ungureanu
Site Name
Spitalul Judetean De Urgenta Dr. Constantin Opris Baia Mare
Department Name
Medical Oncology
Contact Person Name
Dumitru Filip
Contact Person Email
filipd1@yahoo.com
Site Name
Medisprof S.R.L.
Department Name
Medical Oncology
Contact Person Name
Anghel-Adrian Udrea
Contact Person Email
adrianudrea@medisprof.ro
Site Name
Institute Of Oncology Prof. Dr. Ion Chiricuta Cluj-Napoca
Department Name
Medical Oncology
Contact Person Name
Alina Muntean
Contact Person Email
muntean.alina@yahoo.fr
Site Name
Centrul De Oncologie-Euroclinic S.R.L.
Department Name
Medical Oncology
Contact Person Name
Constantin Volovat
Contact Person Email
cvolovat@yahoo.com
Site Name
Institutul Clinic Fundeni
Department Name
Medical Oncology
Contact Person Name
Adina Emilia Croitoru
Contact Person Email
adina.croitoru09@yahoo.com

Hungary

Latest Decision Or Authorization Date
22-04-2025
Number Of Sites
4
Number Of Participants
1

Sites

Site Name
Del-Pesti Centrumkorhaz Orszagos Hematologiai Es Infektologiai Intezet
Department Name
Onkológiai Centrum
Contact Person Name
György Bodoky
Contact Person Email
bodoky.gyorgy@dpckorhaz.hu
Site Name
Orszagos Onkologiai Intezet
Department Name
Mellkasi és Hasüregi Daganatok és Klinikai Farmakológiai Osztály
Contact Person Name
Pintér Tamás
Contact Person Email
tpinter@gmail.com
Site Name
Bacs-Kiskun Varmegyei Oktatokorhaz
Department Name
Onkoradiológiai Központ
Contact Person Name
Kocsis Judit
Contact Person Email
kocsisjucidr@gmail.com
Site Name
University Of Pecs
Department Name
Onkoterápiás Intézet
Contact Person Name
Szabolcs Bellyei
Contact Person Email
bellyeisz@gmail.com

France

Latest Decision Or Authorization Date
13-05-2026
Number Of Sites
11
Number Of Participants
31

Sites

Site Name
Centre Hospitalier Regional Et Universitaire De Brest
Department Name
Medical Oncology
Contact Person Name
Jean-Philippe Metges
Site Name
Institut Regional Du Cancer De Montpellier
Department Name
Medical Oncology
Contact Person Name
Antoine Adenis
Site Name
Institut Gustave Roussy
Department Name
Department of Cancer Medicine
Contact Person Name
Valérie Boige
Contact Person Email
valerie.boige@gustaveroussy.fr
Site Name
Institut Bergonie
Department Name
Medical Oncology
Contact Person Name
Lola Jade Palmieri
Site Name
CARIO Centre Armoricain de Radiotherapie D'Imagerie medicale et D'Oncologie
Department Name
Medical Oncology
Contact Person Name
Jérôme Martin-Babau
Contact Person Email
j.martin@cario-sante.fr
Site Name
Centre Hospitalier Universitaire De Toulouse
Department Name
Digestive Medical oncology
Contact Person Name
Rosine Guimbaud
Contact Person Email
guimbaud.r@chu-toulouse.fr
Site Name
Hopital Huriez
Department Name
Medical Oncology
Contact Person Name
Anne Ploquin
Contact Person Email
anne.ploquin@chu-lille.fr
Site Name
Centre Leon Berard
Department Name
Medical Oncology
Contact Person Name
Clélia Coutzac
Site Name
Centre Hospitalier Universitaire De Poitiers
Department Name
Hepato- gastroenterology department
Contact Person Name
David Tougeron
Contact Person Email
david.tougeron@chu-poitiers.fr
Site Name
Centre Hospitalier Regional De Marseille
Department Name
Digestive Oncology, Hepato- gastroenterology department
Contact Person Name
Muriel Duluc
Contact Person Email
muriel.duluc@ap-hm.fr
Site Name
Centre Francois Baclesse
Department Name
Medical Oncology
Contact Person Name
Marie-Pierre Galais
Contact Person Email
mp.galais@baclesse.fr

Greece

Latest Decision Or Authorization Date
17-04-2026
Number Of Sites
3
Number Of Participants
9

Sites

Site Name
Metropolitan Hospital
Department Name
1st Oncology Clinic
Contact Person Name
Dimitrios Bafaloukos
Site Name
Athens Medical Center S.A.
Department Name
Oncology Department
Contact Person Name
Michalis Karamouzis
Contact Person Email
michalis.karamouzis@gmail.com
Site Name
General Oncological Hospital Of Kifissia Agioi Anargyroi
Department Name
Department of Medical Oncology
Contact Person Name
Eleni Res
Contact Person Email
nellieres@yahoo.gr

Italy

Latest Decision Or Authorization Date
15-04-2026
Number Of Sites
5
Number Of Participants
19

Sites

Site Name
Istituto Europeo Di Oncologia S.r.l.
Department Name
Divisione di Oncologia Medica Gastrointestinale e Tumori Neuroendocrini
Contact Person Name
Lorenzo Gervaso
Contact Person Email
lorenzo.gervaso@ieo.it
Site Name
Humanitas Mirasole S.p.A.
Department Name
Department of Oncology and Hematology
Contact Person Name
Armando Santoro
Site Name
Azienda Unita Sanitaria Locale Della Romagna
Department Name
UOC Oncologia Ravenna Lugo Faenza - Ravenna
Contact Person Name
Stefano Tamberi
Contact Person Email
stefano.tamberi@auslromagna.it
Site Name
Azienda Ospedaliero Universitaria Careggi
Department Name
Department of Medical Oncology 1
Contact Person Name
Lorenzo Antonuzzo
Site Name
Ospedale San Raffaele S.r.l.
Department Name
Dipartimento di Oncologia Medica
Contact Person Name
Silvia Foti
Contact Person Email
foti.silvia@hsr.it

Spain

Latest Decision Or Authorization Date
17-04-2026
Number Of Sites
8
Number Of Participants
13

Sites

Site Name
Hospital Universitario Hm Sanchinarro
Department Name
Oncology
Contact Person Name
Rafael Alvarez Gallego
Site Name
Hospital Universitario Miguel Servet
Department Name
Medical Oncology
Contact Person Name
Roberto Pazo Cid
Contact Person Email
rpazo@salud.aragon.es
Site Name
Hospital Universitari Vall D Hebron
Department Name
Medical Oncology
Contact Person Name
Daniel Acosta
Contact Person Email
dacosta@vhio.net
Site Name
Hospital Universitario Marques De Valdecilla
Department Name
Medical Oncology
Contact Person Name
Fernando Rivera Herrero
Contact Person Email
fernando.rivera@scsalud.es
Site Name
Hospital Universitario Ramon Y Cajal
Department Name
Medical Oncology
Contact Person Name
Federico Longo Munoz
Contact Person Email
fedelongomunoz@hotmail.com
Site Name
Hospital Clinico Universitario De Valencia
Department Name
Medical Oncology
Contact Person Name
Tania Fleitas Kanonnikoff
Contact Person Email
tfleitask@gmail.com
Site Name
Institut Catala D'oncologia
Department Name
Medical Oncology
Contact Person Name
Mariona Calvo-Campos
Contact Person Email
mcalvo@iconcologia.net
Site Name
Hospital Universitario Marques De Valdecilla (duplicate listing)

Poland

Latest Decision Or Authorization Date
20-04-2026
Number Of Sites
2
Number Of Participants
10

Sites

Site Name
Centrum Onkologii Ziemi Lubelskiej Im. Sw. Jana Z Dukli
Department Name
I Chemotherapy Day Unit
Contact Person Name
Agata Chrzanowska- Kapica
Contact Person Email
achrzanowska@cozl.eu
Site Name
Narodowy Instytut Onkologii Im. Marii Skłodowskiej- Curie - Państwowy Instytut Badawczy
Department Name
Department of Oncology and Radiotherapy
Contact Person Name
Lucjan Wyrwicz
Contact Person Email
lucjan.wyrwicz@nio.gov.pl

Sponsor

Primary sponsor

Full Name
Arcus Biosciences Inc.
Organisation Type
Pharmaceutical company
Country Of Registered Address
United States

Contract research organisations

Name
Icon Clinical Research Limited
Responsibilities
[{"id":929261,"code":"4"}]
Name
PRA Hellas CRO A.E.
Responsibilities
[{"id":929268,"code":"1"},{"id":929269,"code":"12"}]
Name
Syneos Health Inc.
Responsibilities
[{"id":929249,"code":"15","value":"Zimberelimab PK"},{"id":929250,"code":"4"}]
Name
PPD (UK) Limited
Responsibilities
[{"id":929265,"code":"8"}]
Name
Veranex Inc.
Responsibilities
[{"id":929264,"code":"10"}]

Third parties

  • {"country":"United States","full_name":"Scout Clinical","duties_or_roles":"Clinical Trial Patient Reimbursement","organisation_type":"Hospital/Clinic/Other health care facility"}
  • {"country":"Hungary","full_name":"Precision for Medicine (HU) Kft.","duties_or_roles":"","organisation_type":"Pharmaceutical company"}
  • {"country":"United States","full_name":"Veranex Inc.","duties_or_roles":"","organisation_type":"Pharmaceutical company"}
  • {"country":"Ireland","full_name":"Icon Clinical Research Limited","duties_or_roles":"","organisation_type":"Pharmaceutical company"}
  • {"country":"United States","full_name":"Ventana Medical Systems Inc.","duties_or_roles":"Tumor biopsy - leftover samples","organisation_type":"Pharmaceutical company"}
  • {"country":"United States","full_name":"United Biosource LLC","duties_or_roles":"","organisation_type":"Pharmaceutical company"}
  • {"country":"United States","full_name":"Signant Health LLC","duties_or_roles":"ePRO/IRT","organisation_type":"Pharmaceutical company"}
  • {"country":"Belgium","full_name":"CellCarta","duties_or_roles":"Tumor biopsy - during study","organisation_type":"Laboratory/Research/Testing facility"}
  • {"country":"United States","full_name":"Syneos Health Inc.","duties_or_roles":"Zimberelimab PK","organisation_type":"Pharmaceutical company"}
  • {"country":"Greece","full_name":"PRA Hellas CRO A.E.","duties_or_roles":"","organisation_type":"Pharmaceutical company"}
  • {"country":"United States","full_name":"Alliance Pharma Inc.","duties_or_roles":"Zimberelimab ADA","organisation_type":"Pharmaceutical company"}
  • {"country":"United States","full_name":"Suvoda LLC","duties_or_roles":"","organisation_type":"Non-Pharmaceutical company"}
  • {"country":"United Kingdom","full_name":"PPD (UK) Limited","duties_or_roles":"","organisation_type":"Pharmaceutical company"}
  • {"country":"Switzerland","full_name":"Clario","duties_or_roles":"","organisation_type":"Health care"}
  • {"country":"United States","full_name":"Mosaic Laboratories LLC","duties_or_roles":"Leftover samples","organisation_type":"Pharmaceutical company"}
  • {"country":"United States","full_name":"Medidata Solutions Inc.","duties_or_roles":"","organisation_type":"Non-Pharmaceutical company"}
  • {"country":"United States","full_name":"Charles River Laboratories Inc.","duties_or_roles":"Domvanalimab PK & ADA","organisation_type":"Pharmaceutical company"}

Investigational products

Investigational Product Name
DOMVANALIMAB
Active Substance
DOMVANALIMAB
Modality
Monoclonal antibody
Routes Of Administration
Concentrate for solution for infusion (intravenous infusion)
Route
IV (concentrate for solution for infusion)
Authorisation Status
1
Frequency
Once every 4 weeks (Q4W) or once every 3 weeks (Q3W) as described for combination schedule
Investigational Product Name
Zimberelimab
Active Substance
ZIMBERELIMAB
Modality
Monoclonal antibody
Routes Of Administration
Concentrate for solution for infusion (intravenous infusion)
Route
IV (concentrate for solution for infusion)
Authorisation Status
1
Frequency
Once every 4 weeks (Q4W) or once every 3 weeks (Q3W) as described for combination schedule
Investigational Product Name
NIVOLUMAB
Active Substance
NIVOLUMAB
Modality
Monoclonal antibody
Routes Of Administration
Concentrate for solution for infusion (intravenous infusion)
Route
IV (concentrate for solution for infusion)
Authorisation Status
2
Frequency
Q2W or Q3W (per comparator arm description)
Investigational Product Name
CAPECITABINE
Active Substance
CAPECITABINE
Modality
Small molecule
Routes Of Administration
Oral use (tablet)
Route
Oral
Authorisation Status
2
Investigational Product Name
FLUOROURACIL
Active Substance
FLUOROURACIL
Modality
Small molecule
Routes Of Administration
Solution for injection/infusion
Route
IV or injection
Authorisation Status
2
Investigational Product Name
OXALIPLATIN
Active Substance
OXALIPLATIN
Modality
Small molecule
Routes Of Administration
Concentrate for solution for infusion
Route
IV (infusion)
Authorisation Status
2
Investigational Product Name
CALCIUM FOLINATE
Active Substance
CALCIUM FOLINATE
Modality
Small molecule
Routes Of Administration
Solution for injection
Route
Injection
Authorisation Status
2
Combination Treatment
Yes

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