Register a trial

The ANZCTR website will be unavailable from 1pm until 3pm (AEDT) on Wednesday the 30th of October for website maintenance. Please be sure to log out of the system in order to avoid any loss of data.

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been endorsed by the ANZCTR. Before participating in a study, talk to your health care provider and refer to this information for consumers
Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/NCT05568095




Registration number
NCT05568095
Ethics application status
Date submitted
3/10/2022
Date registered
5/10/2022

Titles & IDs
Public 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
Scientific 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
Secondary ID [1] 0 0
2022-002222-27
Secondary ID [2] 0 0
STAR-221
Universal Trial Number (UTN)
Trial acronym
STAR-221
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Advanced Upper Gastrointestinal Tract Adenocarcinoma 0 0
Condition category
Condition code

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Treatment: Drugs - Domvanalimab
Treatment: Drugs - Zimberelimab
Treatment: Drugs - Capecitabine
Treatment: Drugs - Fluorouracil
Treatment: Drugs - Leucovorin
Treatment: Drugs - Oxaliplatin
Treatment: Drugs - Nivolumab

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.

Active comparator: Nivolumab + FOLFOX/CAPOX (PI Choice) - Participants in this arm will receive Nivolumab Q2W and FOLFOX Q2W or Nivolumab Q3W + CAPOX Q3W.


Treatment: Drugs: Domvanalimab
Intravenous (IV) Aqueous Solution

Treatment: Drugs: Zimberelimab
IV Aqueous Solution

Treatment: Drugs: Capecitabine
Oral Tablets

Treatment: Drugs: Fluorouracil
IV Aqueous Solution

Treatment: Drugs: Leucovorin
IV Aqueous Solution

Treatment: Drugs: Oxaliplatin
IV Aqueous Solution

Treatment: Drugs: Nivolumab
IV Aqueous Solution
Intervention code [1] 0 0
Treatment: Drugs
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Overall survival
Timepoint [1] 0 0
From randomization until death from any cause (Approximately 15 months)
Secondary outcome [1] 0 0
Progression-free survival (PFS)
Timepoint [1] 0 0
Approximately 15 months
Secondary outcome [2] 0 0
Objective response rate (ORR)
Timepoint [2] 0 0
Approximately 15 months
Secondary outcome [3] 0 0
Duration of response (DOR)
Timepoint [3] 0 0
Approximately 15 months
Secondary outcome [4] 0 0
Incidence and severity of adverse events (AEs) and serious adverse events (SAEs)
Timepoint [4] 0 0
Approximately 15 months

Eligibility
Key inclusion criteria
Key

* 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 status of 0-1.
* At least one measurable target lesion per Response Evaluation Criteria in Solid Tumors (RECIST) v1.1.

Key
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key 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 completion of neoadjuvant or adjuvant therapy.

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

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
Phase
Phase 3
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Active, not recruiting
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
21/11/2022
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
1/05/2026
Actual
Sample size
Target
Accrual to date
Final
1040
Recruitment in Australia
Recruitment state(s)
Recruitment hospital [1] 0 0
Monash University - Clayton
Recruitment hospital [2] 0 0
Gosford Hospital - Gosford
Recruitment hospital [3] 0 0
Liverpool Hospital - Liverpool
Recruitment hospital [4] 0 0
Oncology West - Murdoch - Murdoch
Recruitment postcode(s) [1] 0 0
- Clayton
Recruitment postcode(s) [2] 0 0
- Gosford
Recruitment postcode(s) [3] 0 0
- Liverpool
Recruitment postcode(s) [4] 0 0
- Murdoch
Recruitment outside Australia
Country [1] 0 0
United States of America
State/province [1] 0 0
Arkansas
Country [2] 0 0
United States of America
State/province [2] 0 0
California
Country [3] 0 0
United States of America
State/province [3] 0 0
Connecticut
Country [4] 0 0
United States of America
State/province [4] 0 0
District of Columbia
Country [5] 0 0
United States of America
State/province [5] 0 0
Florida
Country [6] 0 0
United States of America
State/province [6] 0 0
Kentucky
Country [7] 0 0
United States of America
State/province [7] 0 0
Louisiana
Country [8] 0 0
United States of America
State/province [8] 0 0
Massachusetts
Country [9] 0 0
United States of America
State/province [9] 0 0
Michigan
Country [10] 0 0
United States of America
State/province [10] 0 0
Minnesota
Country [11] 0 0
United States of America
State/province [11] 0 0
New York
Country [12] 0 0
United States of America
State/province [12] 0 0
North Carolina
Country [13] 0 0
United States of America
State/province [13] 0 0
Ohio
Country [14] 0 0
United States of America
State/province [14] 0 0
Oregon
Country [15] 0 0
United States of America
State/province [15] 0 0
South Carolina
Country [16] 0 0
United States of America
State/province [16] 0 0
Tennessee
Country [17] 0 0
United States of America
State/province [17] 0 0
Texas
Country [18] 0 0
United States of America
State/province [18] 0 0
Washington
Country [19] 0 0
United States of America
State/province [19] 0 0
Wisconsin
Country [20] 0 0
Argentina
State/province [20] 0 0
Buenos Aires
Country [21] 0 0
Argentina
State/province [21] 0 0
La Rioja
Country [22] 0 0
Argentina
State/province [22] 0 0
Mar del Plata
Country [23] 0 0
Brazil
State/province [23] 0 0
Barretos
Country [24] 0 0
Brazil
State/province [24] 0 0
Ijuí
Country [25] 0 0
Brazil
State/province [25] 0 0
Natal
Country [26] 0 0
Brazil
State/province [26] 0 0
Porto Alegre
Country [27] 0 0
Brazil
State/province [27] 0 0
Rio de Janeiro
Country [28] 0 0
Canada
State/province [28] 0 0
Halifax
Country [29] 0 0
Canada
State/province [29] 0 0
Montreal
Country [30] 0 0
Canada
State/province [30] 0 0
Ottawa
Country [31] 0 0
Canada
State/province [31] 0 0
Toronto
Country [32] 0 0
Chile
State/province [32] 0 0
La Florida
Country [33] 0 0
Chile
State/province [33] 0 0
Providencia
Country [34] 0 0
Chile
State/province [34] 0 0
Puerto Montt
Country [35] 0 0
Chile
State/province [35] 0 0
Recoleta
Country [36] 0 0
Chile
State/province [36] 0 0
Santiago
Country [37] 0 0
Chile
State/province [37] 0 0
Talca
Country [38] 0 0
China
State/province [38] 0 0
Anyang
Country [39] 0 0
China
State/province [39] 0 0
Changzhou
Country [40] 0 0
China
State/province [40] 0 0
Fuzhou
Country [41] 0 0
China
State/province [41] 0 0
Guangzhou
Country [42] 0 0
China
State/province [42] 0 0
Haikou
Country [43] 0 0
China
State/province [43] 0 0
Hangzhou
Country [44] 0 0
China
State/province [44] 0 0
Harbin
Country [45] 0 0
China
State/province [45] 0 0
Hefei
Country [46] 0 0
China
State/province [46] 0 0
Luoyang
Country [47] 0 0
China
State/province [47] 0 0
Shanghai
Country [48] 0 0
China
State/province [48] 0 0
Tianjin
Country [49] 0 0
China
State/province [49] 0 0
Xining
Country [50] 0 0
China
State/province [50] 0 0
Zhengzhou
Country [51] 0 0
France
State/province [51] 0 0
Bordeaux cedex
Country [52] 0 0
France
State/province [52] 0 0
Brest
Country [53] 0 0
France
State/province [53] 0 0
Caen Cedex 5
Country [54] 0 0
France
State/province [54] 0 0
Lille Cedex
Country [55] 0 0
France
State/province [55] 0 0
Lyon
Country [56] 0 0
France
State/province [56] 0 0
Marseille
Country [57] 0 0
France
State/province [57] 0 0
Montpellier
Country [58] 0 0
France
State/province [58] 0 0
Plerin
Country [59] 0 0
France
State/province [59] 0 0
Poitiers
Country [60] 0 0
France
State/province [60] 0 0
Villejuif
Country [61] 0 0
Georgia
State/province [61] 0 0
Kutaisi
Country [62] 0 0
Georgia
State/province [62] 0 0
Tbilisi
Country [63] 0 0
Greece
State/province [63] 0 0
Athens
Country [64] 0 0
Greece
State/province [64] 0 0
Nea Kifisia
Country [65] 0 0
Greece
State/province [65] 0 0
Neo Faliro
Country [66] 0 0
Guatemala
State/province [66] 0 0
Guatemala city
Country [67] 0 0
Guatemala
State/province [67] 0 0
Guatemala
Country [68] 0 0
Guatemala
State/province [68] 0 0
Quetzaltenango
Country [69] 0 0
Hong Kong
State/province [69] 0 0
Happy Valley
Country [70] 0 0
Hong Kong
State/province [70] 0 0
Hong Kong
Country [71] 0 0
Hong Kong
State/province [71] 0 0
Tuen Mun
Country [72] 0 0
Hungary
State/province [72] 0 0
Pecs
Country [73] 0 0
Israel
State/province [73] 0 0
Petah Tikva
Country [74] 0 0
Israel
State/province [74] 0 0
Tel Aviv
Country [75] 0 0
Italy
State/province [75] 0 0
Firenze
Country [76] 0 0
Italy
State/province [76] 0 0
Milano
Country [77] 0 0
Italy
State/province [77] 0 0
Milan
Country [78] 0 0
Italy
State/province [78] 0 0
Rozzano
Country [79] 0 0
Italy
State/province [79] 0 0
Udine
Country [80] 0 0
Japan
State/province [80] 0 0
Akashi City
Country [81] 0 0
Japan
State/province [81] 0 0
Bunkyo-ku
Country [82] 0 0
Japan
State/province [82] 0 0
Chiba
Country [83] 0 0
Japan
State/province [83] 0 0
Fukuoka-shi
Country [84] 0 0
Japan
State/province [84] 0 0
Kashiwa
Country [85] 0 0
Japan
State/province [85] 0 0
Kawasaki-Shi
Country [86] 0 0
Japan
State/province [86] 0 0
Koto
Country [87] 0 0
Japan
State/province [87] 0 0
Kumamoto
Country [88] 0 0
Japan
State/province [88] 0 0
Matsuyama-Shi
Country [89] 0 0
Japan
State/province [89] 0 0
Nagaizumi
Country [90] 0 0
Japan
State/province [90] 0 0
Nagoya
Country [91] 0 0
Japan
State/province [91] 0 0
Niigata
Country [92] 0 0
Japan
State/province [92] 0 0
Osaka
Country [93] 0 0
Japan
State/province [93] 0 0
Ota-Shi
Country [94] 0 0
Japan
State/province [94] 0 0
Saitama
Country [95] 0 0
Japan
State/province [95] 0 0
Tokyo
Country [96] 0 0
Japan
State/province [96] 0 0
Yokohama-shi
Country [97] 0 0
Korea, Republic of
State/province [97] 0 0
Busan
Country [98] 0 0
Korea, Republic of
State/province [98] 0 0
Daegu
Country [99] 0 0
Korea, Republic of
State/province [99] 0 0
Seongnam-si
Country [100] 0 0
Korea, Republic of
State/province [100] 0 0
Seoul
Country [101] 0 0
Lithuania
State/province [101] 0 0
Kaunas
Country [102] 0 0
Lithuania
State/province [102] 0 0
Klaipeda
Country [103] 0 0
Lithuania
State/province [103] 0 0
Vilnius
Country [104] 0 0
Malaysia
State/province [104] 0 0
George Town
Country [105] 0 0
Malaysia
State/province [105] 0 0
Kuala Lumpur
Country [106] 0 0
Malaysia
State/province [106] 0 0
Kuching
Country [107] 0 0
Mexico
State/province [107] 0 0
Colonia Centro
Country [108] 0 0
Mexico
State/province [108] 0 0
Merida
Country [109] 0 0
Mexico
State/province [109] 0 0
Mexico DF
Country [110] 0 0
Mexico
State/province [110] 0 0
San Pedro Garza García
Country [111] 0 0
Mexico
State/province [111] 0 0
Toluca de Lerdo
Country [112] 0 0
Peru
State/province [112] 0 0
San Juan De Miraflores
Country [113] 0 0
Peru
State/province [113] 0 0
Surquillo
Country [114] 0 0
Philippines
State/province [114] 0 0
Bacolod City
Country [115] 0 0
Philippines
State/province [115] 0 0
Baguio
Country [116] 0 0
Philippines
State/province [116] 0 0
Cebu City
Country [117] 0 0
Poland
State/province [117] 0 0
Lublin
Country [118] 0 0
Poland
State/province [118] 0 0
Warszawa
Country [119] 0 0
Portugal
State/province [119] 0 0
Coimbra
Country [120] 0 0
Portugal
State/province [120] 0 0
Lisboa
Country [121] 0 0
Portugal
State/province [121] 0 0
Porto
Country [122] 0 0
Romania
State/province [122] 0 0
Baia Mare
Country [123] 0 0
Romania
State/province [123] 0 0
Bucharest
Country [124] 0 0
Romania
State/province [124] 0 0
Cluj-Napoca
Country [125] 0 0
Romania
State/province [125] 0 0
Craiova
Country [126] 0 0
Romania
State/province [126] 0 0
Flore?ti
Country [127] 0 0
Romania
State/province [127] 0 0
Iasi
Country [128] 0 0
Romania
State/province [128] 0 0
Suceava
Country [129] 0 0
Serbia
State/province [129] 0 0
Belgrade
Country [130] 0 0
Serbia
State/province [130] 0 0
Kragujevac
Country [131] 0 0
Spain
State/province [131] 0 0
Barcelona
Country [132] 0 0
Spain
State/province [132] 0 0
Madrid
Country [133] 0 0
Spain
State/province [133] 0 0
Santander
Country [134] 0 0
Spain
State/province [134] 0 0
Valencia
Country [135] 0 0
Spain
State/province [135] 0 0
Zaragoza
Country [136] 0 0
Thailand
State/province [136] 0 0
Bang Phlat
Country [137] 0 0
Thailand
State/province [137] 0 0
Hat Yai
Country [138] 0 0
Thailand
State/province [138] 0 0
Ubon Ratchathani
Country [139] 0 0
Turkey
State/province [139] 0 0
Adana
Country [140] 0 0
Turkey
State/province [140] 0 0
Ankara
Country [141] 0 0
Turkey
State/province [141] 0 0
Izmit
Country [142] 0 0
Turkey
State/province [142] 0 0
Malatya
Country [143] 0 0
Turkey
State/province [143] 0 0
Mamak
Country [144] 0 0
Turkey
State/province [144] 0 0
Van
Country [145] 0 0
Turkey
State/province [145] 0 0
Yakutiye
Country [146] 0 0
Turkey
State/province [146] 0 0
Yüregir
Country [147] 0 0
United Kingdom
State/province [147] 0 0
London
Country [148] 0 0
United Kingdom
State/province [148] 0 0
Manchester
Country [149] 0 0
United Kingdom
State/province [149] 0 0
Oxford
Country [150] 0 0
United Kingdom
State/province [150] 0 0
Sutton

Funding & Sponsors
Primary sponsor type
Commercial sector/industry
Name
Arcus Biosciences, Inc.
Address
Country
Other collaborator category [1] 0 0
Commercial sector/industry
Name [1] 0 0
Gilead Sciences
Address [1] 0 0
Country [1] 0 0
Other collaborator category [2] 0 0
Commercial sector/industry
Name [2] 0 0
Taiho Pharmaceutical Co., Ltd.
Address [2] 0 0
Country [2] 0 0

Ethics approval
Ethics application status

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Medical Director
Address 0 0
Arcus Biosciences
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Medical Director
Address 0 0
Country 0 0
Phone 0 0
1-888-44-ARCUS
Fax 0 0
Email 0 0
[email protected]
Contact person for scientific queries

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
Yes
What data in particular will be shared?
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.

Supporting document/s available: Study protocol, Statistical analysis plan (SAP), Clinical study report (CSR)
When will data be available (start and end dates)?
Available to whom?
Available for what types of analyses?
How or where can data be obtained?
IPD available at link: https://trials.arcusbio.com/our-transparency-policy


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

No documents have been uploaded by study researchers.


Results not provided in https://clinicaltrials.gov/study/NCT05568095