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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
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United States of America
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Arkansas
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California
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Iasi
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Romania
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Suceava
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Serbia
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Belgrade
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Serbia
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Kragujevac
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Spain
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Barcelona
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Spain
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Madrid
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Santander
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Spain
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Valencia
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Spain
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Zaragoza
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Thailand
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Bang Phlat
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Thailand
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Hat Yai
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Thailand
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Ubon Ratchathani
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Turkey
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Adana
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Turkey
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Ankara
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Edirne
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Turkey
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Istanbul
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Turkey
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Izmit
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Turkey
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Malatya
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Turkey
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Mamak
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Turkey
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Van
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Turkey
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Yakutiye
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Turkey
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Yüregir
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United Kingdom
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London
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United Kingdom
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Manchester
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United Kingdom
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Oxford
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United Kingdom
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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
ClinicalTrials@arcusbio.com
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