Ignite Creation Date:
2025-12-24 @ 4:37 PM
Ignite Modification Date:
2026-01-26 @ 11:42 PM
Study NCT ID:
NCT05329766
Status:
ACTIVE_NOT_RECRUITING
Last Update Posted:
2025-11-26
First Post:
2022-04-08
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
A Safety and Efficacy Study of Treatment Combinations With and Without Chemotherapy in Adult Participants With Advanced Upper Gastrointestinal Tract Malignancies
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24', 'removedCountries': ['Argentina']}, 'conditionBrowseModule': {'meshes': [{'id': 'C562730', 'term': 'Adenocarcinoma Of Esophagus'}, {'id': 'D013274', 'term': 'Stomach Neoplasms'}], 'ancestors': [{'id': 'D005770', 'term': 'Gastrointestinal Neoplasms'}, {'id': 'D004067', 'term': 'Digestive System Neoplasms'}, {'id': 'D009371', 'term': 'Neoplasms by Site'}, {'id': 'D009369', 'term': 'Neoplasms'}, {'id': 'D004066', 'term': 'Digestive System Diseases'}, {'id': 'D005767', 'term': 'Gastrointestinal Diseases'}, {'id': 'D013272', 'term': 'Stomach Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'C000723779', 'term': 'quemliclustat'}, {'id': 'C000719848', 'term': 'zimberelimab'}, {'id': 'D005472', 'term': 'Fluorouracil'}, {'id': 'D002955', 'term': 'Leucovorin'}, {'id': 'D000077150', 'term': 'Oxaliplatin'}], 'ancestors': [{'id': 'D014498', 'term': 'Uracil'}, {'id': 'D011744', 'term': 'Pyrimidinones'}, {'id': 'D011743', 'term': 'Pyrimidines'}, {'id': 'D006573', 'term': 'Heterocyclic Compounds, 1-Ring'}, {'id': 'D006571', 'term': 'Heterocyclic Compounds'}, {'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'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 332}}, 'statusModule': {'overallStatus': 'ACTIVE_NOT_RECRUITING', 'startDateStruct': {'date': '2022-06-10', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-03', 'completionDateStruct': {'date': '2027-06', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-11-24', 'studyFirstSubmitDate': '2022-04-08', 'studyFirstSubmitQcDate': '2022-04-08', 'lastUpdatePostDateStruct': {'date': '2025-11-26', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2022-04-15', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2027-01', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Number of Participants with Adverse Events (AEs)', 'timeFrame': 'Up to 18 months'}, {'measure': 'Objective Response Rate (ORR) as measured by Response Evaluation Criteria in Solid Tumors (RECIST) v1.1', 'timeFrame': 'Up to 18 months'}], 'secondaryOutcomes': [{'measure': 'Objective Response Rate (ORR) as measured by PD-L1 Expression Level', 'timeFrame': 'Up to 18 months'}, {'measure': 'Overall survival (OS)', 'timeFrame': 'From date of first dose until the date of death due to any cause (approximately 18 months)'}, {'measure': 'Progression-free survival (PFS) as determined by the Investigator according to RECIST v1.1', 'timeFrame': 'Up to 18 months'}, {'measure': 'Disease Control (complete response, partial response, or stable disease) for greater than equal to 12 weeks', 'timeFrame': 'Up to 18 months'}, {'measure': 'Duration of response (DOR) as determined by the Investigator according to RECIST v1.1', 'timeFrame': 'Up to 18 months'}, {'measure': 'Plasma concentration of domvanalimab', 'timeFrame': 'Up to 18 months'}, {'measure': 'Plasma concentration of zimberelimab', 'timeFrame': 'Up to 18 months'}, {'measure': 'Plasma concentration of quemliclustat', 'timeFrame': 'Up to 18 months'}, {'measure': 'Percentage of participants with anti-drug antibodies to domvanalimab', 'timeFrame': 'Up to 18 months'}, {'measure': 'Percentage of participants with anti-drug antibodies to zimberelimab', 'timeFrame': 'Up to 18 months'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': True, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Domvanalimab', 'Quemliclustat', 'Zimberelimab', 'Esophageal adenocarcinoma', 'Gastric adenocarcinoma', 'Gastric cancer', 'Gastroesophageal junction cancer', 'Anti-PD-1 antibody', 'Anti-CD73', 'anti-TIGIT antibody'], 'conditions': ['Gastrointestinal Tract Malignancies']}, 'referencesModule': {'references': [{'pmid': '41109921', 'type': 'DERIVED', 'citation': 'Janjigian YY, Oh DY, Pelster M, Wainberg ZA, Prusty S, Nelson S, DuPage A, Thompson A, Koralek DO, Sison EAR, Rha SY. Domvanalimab and zimberelimab in advanced gastric, gastroesophageal junction or esophageal cancer: a phase 2 trial. Nat Med. 2025 Dec;31(12):4274-4280. doi: 10.1038/s41591-025-04022-w. Epub 2025 Oct 18.'}], 'seeAlsoLinks': [{'url': 'https://trials.arcusbio.com/study/?id=ARC-21', 'label': 'ARC-21 - Public website'}]}, 'descriptionModule': {'briefSummary': 'The purpose of this study is to evaluate the safety and preliminary clinical activity of treatment combinations with and without chemotherapy in participants with locally advanced unresectable or metastatic gastric, GEJ, and esophageal adenocarcinoma. Chemotherapy will consist of FOLFOX (oxaliplatin, leucovorin, fluorouracil).'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': "Key Inclusion Criteria:\n\n* Participants with histologically confirmed diagnosis of locally advanced unresectable or metastatic gastric, GEJ, or esophageal adenocarcinoma with life expectancy ≥3 months as assessed by the Investigator\n* Eastern cooperative oncology group (ECOG) Performance Score of 0-1\n* At least one measurable target lesion per RECIST v1.1.\n* Adequate organ and marrow function\n* Able to provide an archival tumor sample that is representative of the cancer under investigation and suitable for central PD-L1 testing\n\nKey Exclusion Criteria:\n\n* Participants with underlying medical conditions that, in the Investigator's or Sponsor's opinion, will make the administration of investigational products hazardous\n* Only for Cohort A: Known Human Epidermal Growth Factor Receptor 2 (HER-2) positive tumor\n* Known untreated, symptomatic, or actively progressing central nervous system (brain) metastases. Participants with leptomeningeal metastases are excluded from enrollment.\n* Discontinued use of prior immune checkpoint therapy due to immune related adverse events; received prior treatment with an anti-TIGIT monoclonal antibody.\n* History of trauma or major surgery within 28 days prior to enrollment.\n\nNote: Other protocol defined Inclusion/Exclusion criteria may apply."}, 'identificationModule': {'nctId': 'NCT05329766', 'acronym': 'EDGE-Gastric', 'briefTitle': 'A Safety and Efficacy Study of Treatment Combinations With and Without Chemotherapy in Adult Participants With Advanced Upper Gastrointestinal Tract Malignancies', 'organization': {'class': 'INDUSTRY', 'fullName': 'Arcus Biosciences, Inc.'}, 'officialTitle': 'A Phase 2 Trial to Evaluate the Safety and Efficacy of Combination Therapies in Patients With Advanced Upper Gastrointestinal Tract Malignancies (EDGE-Gastric)', 'orgStudyIdInfo': {'id': 'ARC-21'}, 'secondaryIdInfos': [{'id': '2021-006291-16', 'type': 'EUDRACT_NUMBER'}, {'id': '2024-511917-40-00', 'type': 'CTIS'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'A1: First Line - Treatment Naïve Participants', 'description': 'Domvanalimab and zimberelimab once every 4 weeks (Q4W) in addition to FOLFOX chemotherapy by intravenous (IV) infusion once every 2 weeks (Q2W)', 'interventionNames': ['Drug: Domvanalimab', 'Drug: Zimberelimab', 'Drug: Fluorouracil', 'Drug: Leucovorin', 'Drug: Oxaliplatin']}, {'type': 'EXPERIMENTAL', 'label': 'A2: First Line - Treatment Naïve Participants', 'description': 'Zimberelimab Q4W in addition to chemotherapy with FOLFOX administered by IV infusion Q2W', 'interventionNames': ['Drug: Zimberelimab', 'Drug: Fluorouracil', 'Drug: Leucovorin', 'Drug: Oxaliplatin']}, {'type': 'EXPERIMENTAL', 'label': 'A3 First Line - Treatment Naïve Participants', 'description': 'Non-randomized A3 safety run-in cohort: Domvanalimab and zimberelimab co-administered Q4W via IV infusion over 60 minutes in addition to FOLFOX chemotherapy via IV infusion Q2W.\n\nAfter completion of A3 safety run-in cohort, participants are randomized to the A3 arm. Domvanalimab and zimberelimab co-administered Q4W via IV infusion over 30 minutes, in addition to FOLFOX chemotherapy via IV infusion Q2W', 'interventionNames': ['Drug: Domvanalimab', 'Drug: Zimberelimab', 'Drug: Fluorouracil', 'Drug: Leucovorin', 'Drug: Oxaliplatin']}, {'type': 'EXPERIMENTAL', 'label': 'A4 First Line - Treatment Naïve Participants', 'description': 'Zimberelimab administered Q4W via IV infusion over 30 minutes, in addition to FOLFOX chemotherapy via IV infusion Q2W', 'interventionNames': ['Drug: Zimberelimab', 'Drug: Fluorouracil', 'Drug: Leucovorin', 'Drug: Oxaliplatin']}, {'type': 'EXPERIMENTAL', 'label': 'B1: Second Line or greater Checkpoint Inhibitor Naïve Participants', 'description': 'Domvanalimab and zimberelimab administered once every three weeks (Q3W) by IV infusion', 'interventionNames': ['Drug: Domvanalimab', 'Drug: Zimberelimab']}, {'type': 'EXPERIMENTAL', 'label': 'B2: Second Line or greater Checkpoint Inhibitor Naïve Participants', 'description': 'Quemliclustat Q2W and zimberelimab Q4W administered by IV infusion', 'interventionNames': ['Drug: Quemliclustat', 'Drug: Zimberelimab']}, {'type': 'EXPERIMENTAL', 'label': 'Cohort C1: Second Line or greater - Checkpoint Inhibitor Experienced Participants', 'description': 'Domvanalimab and zimberelimab Q3W administered by IV infusion', 'interventionNames': ['Drug: Domvanalimab', 'Drug: Zimberelimab']}], 'interventions': [{'name': 'Domvanalimab', 'type': 'DRUG', 'description': 'Administered as specified in the treatment arm', 'armGroupLabels': ['A1: First Line - Treatment Naïve Participants', 'A3 First Line - Treatment Naïve Participants', 'B1: Second Line or greater Checkpoint Inhibitor Naïve Participants', 'Cohort C1: Second Line or greater - Checkpoint Inhibitor Experienced Participants']}, {'name': 'Quemliclustat', 'type': 'DRUG', 'description': 'Administered as specified in the treatment arm', 'armGroupLabels': ['B2: Second Line or greater Checkpoint Inhibitor Naïve Participants']}, {'name': 'Zimberelimab', 'type': 'DRUG', 'description': 'Administered as specified in the treatment arm', 'armGroupLabels': ['A1: First Line - Treatment Naïve Participants', 'A2: First Line - Treatment Naïve Participants', 'A3 First Line - Treatment Naïve Participants', 'A4 First Line - Treatment Naïve Participants', 'B1: Second Line or greater Checkpoint Inhibitor Naïve Participants', 'B2: Second Line or greater Checkpoint Inhibitor Naïve Participants', 'Cohort C1: Second Line or greater - Checkpoint Inhibitor Experienced Participants']}, {'name': 'Fluorouracil', 'type': 'DRUG', 'description': 'Administered as specified in the treatment arm', 'armGroupLabels': ['A1: First Line - Treatment Naïve Participants', 'A2: First Line - Treatment Naïve Participants', 'A3 First Line - Treatment Naïve Participants', 'A4 First Line - Treatment Naïve Participants']}, {'name': 'Leucovorin', 'type': 'DRUG', 'description': 'Administered as specified in the treatment arm', 'armGroupLabels': ['A1: First Line - Treatment Naïve Participants', 'A2: First Line - Treatment Naïve Participants', 'A3 First Line - Treatment Naïve Participants', 'A4 First Line - Treatment Naïve Participants']}, {'name': 'Oxaliplatin', 'type': 'DRUG', 'description': 'Administered as specified in the treatment arm', 'armGroupLabels': ['A1: First Line - Treatment Naïve Participants', 'A2: First Line - Treatment Naïve Participants', 'A3 First Line - Treatment Naïve Participants', 'A4 First Line - Treatment Naïve Participants']}]}, 'contactsLocationsModule': {'locations': [{'zip': '85054', 'city': 'Phoenix', 'state': 'Arizona', 'country': 'United States', 'facility': 'Mayo Clinic - Arizona', 'geoPoint': {'lat': 33.44838, 'lon': -112.07404}}, {'zip': '90033', 'city': 'Los Angeles', 'state': 'California', 'country': 'United States', 'facility': 'USC/Norris Comprehensive Cancer Center', 'geoPoint': {'lat': 34.05223, 'lon': -118.24368}}, {'zip': '90024', 'city': 'Santa Monica', 'state': 'California', 'country': 'United States', 'facility': 'Ronald Reagan UCLA Medical Center', 'geoPoint': {'lat': 34.01949, 'lon': -118.49138}}, {'zip': '06418', 'city': 'Derby', 'state': 'Connecticut', 'country': 'United States', 'facility': 'Yale Cancer Center', 'geoPoint': {'lat': 41.32065, 'lon': -73.089}}, {'zip': '33901', 'city': 'Fort Myers', 'state': 'Florida', 'country': 'United States', 'facility': 'Florida Cancer Specialist - 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