Ignite Creation Date:
2025-12-24 @ 2:02 PM
Ignite Modification Date:
2025-12-29 @ 1:53 AM
Study NCT ID:
NCT05568095
Status:
ACTIVE_NOT_RECRUITING
Last Update Posted:
2025-12-23
First Post:
2022-10-03
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief 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
Sponsor:
Organization:
Raw JSON
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'Deoxycytidine'}, {'id': 'D003562', 'term': 'Cytidine'}, {'id': 'D011741', 'term': 'Pyrimidine Nucleosides'}, {'id': 'D011743', 'term': 'Pyrimidines'}, {'id': 'D006573', 'term': 'Heterocyclic Compounds, 1-Ring'}, {'id': 'D006571', 'term': 'Heterocyclic Compounds'}, {'id': 'D014498', 'term': 'Uracil'}, {'id': 'D011744', 'term': 'Pyrimidinones'}, {'id': 'D003853', 'term': 'Deoxyribonucleosides'}, {'id': 'D009705', 'term': 'Nucleosides'}, {'id': 'D009706', 'term': 'Nucleic Acids, Nucleotides, and Nucleosides'}, {'id': 'D005575', 'term': 'Formyltetrahydrofolates'}, {'id': 'D013763', 'term': 'Tetrahydrofolates'}, {'id': 'D005492', 'term': 'Folic Acid'}, {'id': 'D011622', 'term': 'Pterins'}, {'id': 'D011621', 'term': 'Pteridines'}, {'id': 'D006574', 'term': 'Heterocyclic Compounds, 2-Ring'}, {'id': 'D000072471', 'term': 'Heterocyclic Compounds, Fused-Ring'}, {'id': 'D003067', 'term': 'Coenzymes'}, {'id': 'D045762', 'term': 'Enzymes and Coenzymes'}, {'id': 'D056831', 'term': 'Coordination Complexes'}, {'id': 'D009930', 'term': 'Organic Chemicals'}, {'id': 'D061067', 'term': 'Antibodies, Monoclonal, Humanized'}, {'id': 'D000911', 'term': 'Antibodies, Monoclonal'}, {'id': 'D000906', 'term': 'Antibodies'}, {'id': 'D007136', 'term': 'Immunoglobulins'}, {'id': 'D007162', 'term': 'Immunoproteins'}, {'id': 'D001798', 'term': 'Blood Proteins'}, {'id': 'D011506', 'term': 'Proteins'}, {'id': 'D000602', 'term': 'Amino Acids, Peptides, and Proteins'}, {'id': 'D012712', 'term': 'Serum Globulins'}, {'id': 'D005916', 'term': 'Globulins'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE3'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 1040}}, 'statusModule': {'overallStatus': 'ACTIVE_NOT_RECRUITING', 'startDateStruct': {'date': '2022-11-21', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-04', 'completionDateStruct': {'date': '2026-06', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-12-19', 'studyFirstSubmitDate': '2022-10-03', 'studyFirstSubmitQcDate': '2022-10-03', 'lastUpdatePostDateStruct': {'date': '2025-12-23', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2022-10-05', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2026-06', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Overall survival', 'timeFrame': 'From date of randomization until date of death from any cause (Approximately 15 months)]'}], 'secondaryOutcomes': [{'measure': 'Progression-free survival (PFS)', 'timeFrame': 'From date of randomization to date of the first documentation of disease progression or date of death from any cause, whichever comes first (Approximately 15 months)'}, {'measure': 'Objective response rate (ORR)', 'timeFrame': 'Proportion of randomized participants who achieved a confirmed best overall response of complete response (CR) or partial response (PR) (Approximately 15 months)'}, {'measure': 'Duration of response (DOR)', 'timeFrame': 'From the date of first confirmed response (CR or PR), until the date of first documented disease progression or date of death from any cause, whichever comes first (Approximately 15 months)'}, {'measure': 'Incidence and severity of adverse events (AEs) and serious adverse events (SAEs)', 'timeFrame': 'From on or after the date of first dose of any study treatment to the date of last study treatment specific safety follow-up or date of initiation of subsequent systemic anti-cancer therapy, whichever occurs first (Approximately 15 months)'}, {'measure': 'Time to first symptom deterioration in the FACT-Ga gastric cancer subscale.', 'timeFrame': 'From the date of randomization to change from baseline in subscale greater than or equal to the deterioration threshold, or death from any cause, whichever comes first (Approximately 15 months)'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': True, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Domvanalimab', 'Zimberelimab', 'Nivolumab', 'Advanced upper gastrointestinal tract adenocarcinoma', 'Gastroesophageal junction cancer', 'Esophageal adenocarcinoma', 'Gastric cancer', 'Gastric adenocarcinoma'], 'conditions': ['Advanced Upper Gastrointestinal Tract Adenocarcinoma']}, 'referencesModule': {'seeAlsoLinks': [{'url': 'https://trials.arcusbio.com/study/?id=STAR-221', 'label': 'STAR-221 Public Website'}]}, 'descriptionModule': {'briefSummary': '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.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': "Key Inclusion Criteria:\n\n* 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.\n* Histologically confirmed diagnosis of locally advanced unresectable or metastatic gastric, GEJ, or esophageal adenocarcinoma.\n* Eastern Cooperative Oncology Group (ECOG) performance status of 0-1.\n* At least one measurable target lesion per Response Evaluation Criteria in Solid Tumors (RECIST) v1.1.\n\nKey Exclusion Criteria:\n\n* 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:\n* 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.\n* 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.\n* History of prior solid-organ transplantation, including allogenic bone marrow transplantation.\n* Dementia, psychiatric, or substance abuse disorders that would interfere with satisfying the requirements of the trial.\n* Known human epidermal growth factor receptor 2 (HER-2) positive tumor.\n* Known untreated, symptomatic, or actively progressing central nervous system (CNS) (brain) metastases. Participants with leptomeningeal metastases are excluded from enrollment.\n* Received prior systemic treatment for locally advanced unresectable or metastatic gastric, GEJ, or esophageal adenocarcinoma.\n* Disease progression within 6 months of completion of neoadjuvant or adjuvant therapy.\n\nNote: Other protocol defined Inclusion/Exclusion criteria may apply."}, 'identificationModule': {'nctId': 'NCT05568095', 'acronym': 'STAR-221', 'briefTitle': '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', 'organization': {'class': 'INDUSTRY', 'fullName': 'Arcus Biosciences, Inc.'}, 'officialTitle': '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', 'orgStudyIdInfo': {'id': 'STAR-221'}, 'secondaryIdInfos': [{'id': 'jRCT2051220179', 'type': 'REGISTRY', 'domain': 'Japan Registry of Clinical Trials'}, {'id': 'MOH_2023-04-30_012590', 'type': 'REGISTRY', 'domain': 'Israel Clinical Research Site - MyTrials'}, {'id': 'CTR20233469', 'type': 'REGISTRY', 'domain': 'China: Drug Clinical Trial Registration and Information Disclosure Platform'}, {'id': 'CTR20233470', 'type': 'REGISTRY', 'domain': 'China: Drug Clinical Trial Registration and Information Disclosure Platform'}, {'id': '2023-507522-16-00', 'type': 'OTHER', 'domain': 'EMA: Clinical Trials Information System (CTIS)'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Domvanalimab + Zimberelimab + FOLFOX/CAPOX (PI Choice)', 'description': '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.', 'interventionNames': ['Drug: Domvanalimab', 'Drug: Zimberelimab', 'Drug: Capecitabine', 'Drug: Fluorouracil', 'Drug: Leucovorin', 'Drug: Oxaliplatin']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Nivolumab + FOLFOX/CAPOX (PI Choice)', 'description': 'Participants in this arm will receive Nivolumab Q2W and FOLFOX Q2W or Nivolumab Q3W + CAPOX Q3W.', 'interventionNames': ['Drug: Capecitabine', 'Drug: Fluorouracil', 'Drug: Leucovorin', 'Drug: Oxaliplatin', 'Drug: Nivolumab']}], 'interventions': [{'name': 'Domvanalimab', 'type': 'DRUG', 'otherNames': ['AB154'], 'description': 'Intravenous (IV) Aqueous Solution', 'armGroupLabels': ['Domvanalimab + Zimberelimab + FOLFOX/CAPOX (PI Choice)']}, {'name': 'Zimberelimab', 'type': 'DRUG', 'otherNames': ['AB122'], 'description': 'IV Aqueous Solution', 'armGroupLabels': ['Domvanalimab + Zimberelimab + FOLFOX/CAPOX (PI Choice)']}, {'name': 'Capecitabine', 'type': 'DRUG', 'description': 'Oral Tablets', 'armGroupLabels': ['Domvanalimab + Zimberelimab + FOLFOX/CAPOX (PI Choice)', 'Nivolumab + FOLFOX/CAPOX (PI Choice)']}, {'name': 'Fluorouracil', 'type': 'DRUG', 'description': 'IV Aqueous Solution', 'armGroupLabels': ['Domvanalimab + Zimberelimab + FOLFOX/CAPOX (PI Choice)', 'Nivolumab + FOLFOX/CAPOX (PI Choice)']}, {'name': 'Leucovorin', 'type': 'DRUG', 'description': 'IV Aqueous Solution', 'armGroupLabels': ['Domvanalimab + Zimberelimab + FOLFOX/CAPOX (PI Choice)', 'Nivolumab + FOLFOX/CAPOX (PI Choice)']}, {'name': 'Oxaliplatin', 'type': 'DRUG', 'description': 'IV Aqueous Solution', 'armGroupLabels': ['Domvanalimab + Zimberelimab + FOLFOX/CAPOX (PI Choice)', 'Nivolumab + FOLFOX/CAPOX (PI Choice)']}, {'name': 'Nivolumab', 'type': 'DRUG', 'description': 'IV Aqueous Solution', 'armGroupLabels': ['Nivolumab + FOLFOX/CAPOX (PI Choice)']}]}, 'contactsLocationsModule': {'locations': [{'zip': '71913', 'city': 'Hot Springs', 'state': 'Arkansas', 'country': 'United States', 'facility': 'Genesis Cancer Center and Blood Institute - Hot Springs', 'geoPoint': {'lat': 34.5037, 'lon': -93.05518}}, {'zip': '90027', 'city': 'Los Angeles', 'state': 'California', 'country': 'United States', 'facility': 'Kaiser Permanente - Los Angeles Medical Center', 'geoPoint': {'lat': 34.05223, 'lon': -118.24368}}, {'zip': '90033', 'city': 'Los Angeles', 'state': 'California', 'country': 'United States', 'facility': 'Norris Comprehensive Cancer Center', 'geoPoint': {'lat': 34.05223, 'lon': -118.24368}}, {'zip': '92868', 'city': 'Orange', 'state': 'California', 'country': 'United States', 'facility': 'University of California Irvine Health Chao Family Comprehensive Cancer Center', 'geoPoint': {'lat': 33.78779, 'lon': -117.85311}}, {'zip': '90404', 'city': 'Santa Monica', 'state': 'California', 'country': 'United States', 'facility': 'UCLA Health - Santa Monica Cancer Care', 'geoPoint': {'lat': 34.01949, 'lon': -118.49138}}, {'zip': '06520', 'city': 'New Haven', 'state': 'Connecticut', 'country': 'United States', 'facility': 'Yale Cancer Center', 'geoPoint': {'lat': 41.30815, 'lon': -72.92816}}, {'zip': '22057', 'city': 'Washington D.C.', 'state': 'District of Columbia', 'country': 'United States', 'facility': 'Georgetown Lombardi Comprehensive Cancer Center', 'geoPoint': {'lat': 38.89511, 'lon': -77.03637}}, {'zip': '33901', 'city': 'Fort Myers', 'state': 'Florida', 'country': 'United States', 'facility': 'SCRI - Florida Cancer Specialists - South Region Research Office', 'geoPoint': {'lat': 26.62168, 'lon': -81.84059}}, {'zip': '33705', 'city': 'St. Petersburg', 'state': 'Florida', 'country': 'United States', 'facility': 'SCRI - Florida Cancer Specialists - North Region Research Office', 'geoPoint': {'lat': 27.77086, 'lon': -82.67927}}, {'zip': '32308', 'city': 'Tallahassee', 'state': 'Florida', 'country': 'United States', 'facility': 'SCRI - Florida Cancer Specialists - Panhandle Research Office', 'geoPoint': {'lat': 30.43826, 'lon': -84.28073}}, {'zip': '33401', 'city': 'West Palm Beach', 'state': 'Florida', 'country': 'United States', 'facility': 'SCRI - Florida Cancer Specialists - East Region Research Office', 'geoPoint': {'lat': 26.71534, 'lon': -80.05337}}, {'zip': '40202', 'city': 'Louisville', 'state': 'Kentucky', 'country': 'United States', 'facility': 'University of Louisville James Graham Brown Cancer Center', 'geoPoint': {'lat': 38.25424, 'lon': -85.75941}}, {'zip': '40217', 'city': 'Louisville', 'state': 'Kentucky', 'country': 'United States', 'facility': 'Norton Cancer Institute - 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38th Street', 'geoPoint': {'lat': 40.71427, 'lon': -74.00597}}, {'zip': '10065', 'city': 'New York', 'state': 'New York', 'country': 'United States', 'facility': 'Memorial Sloan Kettering Cancer Center - New York', 'geoPoint': {'lat': 40.71427, 'lon': -74.00597}}, {'zip': '27710', 'city': 'Durham', 'state': 'North Carolina', 'country': 'United States', 'facility': 'Duke University Medical Center', 'geoPoint': {'lat': 35.99403, 'lon': -78.89862}}, {'zip': '44106', 'city': 'Cleveland', 'state': 'Ohio', 'country': 'United States', 'facility': 'Cleveland Clinic - Taussig Cancer Center', 'geoPoint': {'lat': 41.4995, 'lon': -81.69541}}, {'zip': '44106', 'city': 'Cleveland', 'state': 'Ohio', 'country': 'United States', 'facility': 'University Hospitals Cleveland Medical Center', 'geoPoint': {'lat': 41.4995, 'lon': -81.69541}}, {'zip': '44111', 'city': 'Cleveland', 'state': 'Ohio', 'country': 'United States', 'facility': 'Cleveland Clin - Fairview Hosp', 'geoPoint': {'lat': 41.4995, 'lon': -81.69541}}, {'zip': '43219', 'city': 'Columbus', 'state': 'Ohio', 'country': 'United States', 'facility': 'Mark H. 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