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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)

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 evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT05568095
Recruitment Status : Recruiting
First Posted : October 5, 2022
Last Update Posted : May 17, 2023
Sponsor:
Collaborator:
Gilead Sciences
Information provided by (Responsible Party):
Arcus Biosciences, Inc.

Study Description
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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.

Condition or disease Intervention/treatment Phase
Advanced Upper Gastrointestinal Tract Adenocarcinoma Drug: Domvanalimab Drug: Zimberelimab Drug: Capecitabine Drug: Fluorouracil Drug: Leucovorin Drug: Oxaliplatin Drug: Nivolumab Phase 3

Study Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 970 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
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
Actual Study Start Date : November 21, 2022
Estimated Primary Completion Date : September 2026
Estimated Study Completion Date : January 2027

Resource links provided by the National Library of Medicine

Drug Information available for: Nivolumab

Arms and Interventions
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Arm Intervention/treatment
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.
 Drug: Domvanalimab
Intravenous (IV) Aqueous Solution
Other Name: AB154

Drug: Zimberelimab
IV Aqueous Solution
Other Name: AB122

Drug: Capecitabine
Oral Tablets

Drug: Fluorouracil
IV Aqueous Solution

Drug: Leucovorin
IV Aqueous Solution

Drug: Oxaliplatin
IV Aqueous Solution
Active Comparator: Nivolumab + FOLFOX/CAPOX (PI Choice)
Participants in this arm will receive Nivolumab Q2W and FOLFOX Q2W or Nivolumab Q3W + CAPOX Q3W.
 Drug: Capecitabine
Oral Tablets

Drug: Fluorouracil
IV Aqueous Solution

Drug: Leucovorin
IV Aqueous Solution

Drug: Oxaliplatin
IV Aqueous Solution

Drug: Nivolumab
IV Aqueous Solution


Outcome Measures
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Primary Outcome Measures :
  1. Overall survival [ Time Frame: From randomization until death from any cause (Approximately 15 months) ]

Secondary Outcome Measures :
  1. Progression-free survival (PFS) [ Time Frame: Approximately 15 months ]
  2. Objective response rate (ORR) [ Time Frame: Approximately 15 months ]
  3. Duration of response (DOR) [ Time Frame: Approximately 15 months ]
  4. Incidence and severity of adverse events (AEs) and serious adverse events (SAEs) [ Time Frame: Approximately 15 months ]

Eligibility Criteria
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Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.

Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT05568095


Contacts
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Contact: Medical Director +1-510-462-3330 clinicalTrialInquiry@arcusbio.com

Locations
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Sponsors and Collaborators
Arcus Biosciences, Inc.
Gilead Sciences
Investigators
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Study Director: Medical Director Arcus Biosciences
More Information
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Responsible Party: Arcus Biosciences, Inc.
ClinicalTrials.gov Identifier: NCT05568095    
Other Study ID Numbers: STAR-221
2022-002222-27 ( EudraCT Number )
jRCT2051220179 ( Registry Identifier: Japan Registry of Clinical Trials )
MOH_2023-04-30_012590 ( Registry Identifier: Israel Clinical Research Site - MyTrials )
First Posted: October 5, 2022    Key Record Dates
Last Update Posted: May 17, 2023
Last Verified: May 2023
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
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.
URL: https://trials.arcusbio.com/our-transparency-policy

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Arcus Biosciences, Inc.:
Domvanalimab
Zimberelimab
Nivolumab
Advanced upper gastrointestinal tract adenocarcinoma
 Gastroesophageal junction cancer
Esophageal adenocarcinoma
Gastric cancer
Gastric adenocarcinoma
Additional relevant MeSH terms:
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Adenocarcinoma
Carcinoma
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Neoplasms
Leucovorin
Fluorouracil
Capecitabine
Oxaliplatin
Nivolumab
Antimetabolites
Molecular Mechanisms of Pharmacological Action
 Antimetabolites, Antineoplastic
Antineoplastic Agents
Immunosuppressive Agents
Immunologic Factors
Physiological Effects of Drugs
Antineoplastic Agents, Immunological
Immune Checkpoint Inhibitors
Antidotes
Protective Agents
Vitamin B Complex
Vitamins
Micronutrients