Ignite Creation Date:
2025-12-26 @ 11:14 AM
Ignite Modification Date:
2025-12-29 @ 7:53 PM
Study NCT ID:
NCT06256328
Status:
ACTIVE_NOT_RECRUITING
Last Update Posted:
2024-07-29
First Post:
2024-01-23
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
A Study to Investigate the Efficacy and Safety of ONO-4578 in Combination With Nivolumab and Chemotherapy in Chemotherapy-naïve Participants With HER2-negative Unresectable Advanced or Recurrent Gastric Cancer (Including Esophagogastric Junction Cancer)
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'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': 'D000077150', 'term': 'Oxaliplatin'}, {'id': 'D000069287', 'term': 'Capecitabine'}, {'id': 'C079198', 'term': 'S 1 (combination)'}, {'id': 'D000077594', 'term': 'Nivolumab'}], 'ancestors': [{'id': 'D056831', 'term': 'Coordination Complexes'}, {'id': 'D009930', 'term': 'Organic Chemicals'}, {'id': 'D003841', 'term': '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': 'D005472', 'term': 'Fluorouracil'}, {'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': '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': ['PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'TRIPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 210}}, 'statusModule': {'overallStatus': 'ACTIVE_NOT_RECRUITING', 'startDateStruct': {'date': '2023-12-06', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-07', 'completionDateStruct': {'date': '2027-07-31', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2024-07-25', 'studyFirstSubmitDate': '2024-01-23', 'studyFirstSubmitQcDate': '2024-02-04', 'lastUpdatePostDateStruct': {'date': '2024-07-29', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2024-02-13', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2025-11-30', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Progression-free survival (PFS) (site investigator assessment)', 'timeFrame': 'up to 2years'}], 'secondaryOutcomes': [{'measure': 'Overall survival (OS)', 'timeFrame': 'up to 2years'}, {'measure': 'Objective response rate (ORR) (site investigator assessment)', 'timeFrame': 'up to 2years'}, {'measure': 'Best overall response (BOR) (site investigator assessment)', 'timeFrame': 'up to 2years'}, {'measure': 'Duration of response (DOR) (site investigator assessment)', 'timeFrame': 'up to 2years'}, {'measure': 'Disease control rate (DCR) (site investigator assessment)', 'timeFrame': 'up to 2years'}, {'measure': 'Time to response (TTR) (site investigator assessment)', 'timeFrame': 'up to 2years'}, {'measure': 'Maximum percent change in the sum diameters of the target lesions (site investigator assessment)', 'timeFrame': 'up to 2years'}, {'measure': 'Progression-free survival after the next line of therapy (PFS2) (site investigator assessment)', 'timeFrame': 'up to 2years'}, {'measure': 'Adverse event (AE)', 'timeFrame': 'Up to 30 days after the last dose', 'description': 'Number of participants with treatment-emergent adverse events (TEAEs) as assessed by CTCAE v5.0'}]}, 'oversightModule': {'isUsExport': True, 'oversightHasDmc': True, 'isFdaRegulatedDrug': True, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Gastric Cancer']}, 'descriptionModule': {'briefSummary': 'This study is to compare and evaluate the efficacy and safety of the treatment with ONO-4578 in combination with nivolumab and chemotherapy with those of the treatment with placebo in combination with nivolumab and chemotherapy in chemotherapy-naïve participants with HER2- negative unresectable advanced or recurrent gastric cancer (including esophagogastric junction cancer).'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Patients with gastric or esophagogastric junction cancer histologically diagnosed as adenocarcinoma\n* Patients have not been treated with systemic chemotherapy as first-line therapy\n* Patients who can provide tumor tissue samples\n\nExclusion Criteria:\n\n* Patients unable to take oral medicines\n* Patients with HER2-positive\n* Patients with contraindications to nivolumab, oxaliplatin, S-1, or capecitabine\n* Patients who have a history of severe drug-related adverse reactions caused by non- steroidal anti-inflammatory drugs (NSAIDs) or who have complications caused by NSAIDs requiring treatment\n* Patients with concurrent autoimmune disease or a history of chronic or recurrent autoimmune disease, such as rheumatoid arthritis\n* Patients with headache and/or nausea associated with brain metastasis'}, 'identificationModule': {'nctId': 'NCT06256328', 'briefTitle': 'A Study to Investigate the Efficacy and Safety of ONO-4578 in Combination With Nivolumab and Chemotherapy in Chemotherapy-naïve Participants With HER2-negative Unresectable Advanced or Recurrent Gastric Cancer (Including Esophagogastric Junction Cancer)', 'organization': {'class': 'INDUSTRY', 'fullName': 'Ono Pharmaceutical Co. Ltd'}, 'officialTitle': 'A Randomized, Multicenter, Double-blind, Phase II Study to Compare the Efficacy and Safety of the Treatment With ONO-4578 in Combination With Nivolumab, Fluoropyrimidine-based and Platinum- Based Chemotherapy (Hereinafter Referred to as Chemotherapy) With Those of the Treatment With Placebo in Combination With Nivolumab and Chemotherapy in Chemotherapy-naïve Participants With Human Epidermal Growth Factor Receptor 2 (HER2)-Negative Unresectable Advanced or Recurrent Gastric Cancer (Including Esophagogastric Junction Cancer)', 'orgStudyIdInfo': {'id': 'ONO-4578-08'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'ONO-4578+Nivolumab+chemotherapy', 'interventionNames': ['Drug: ONO-4578', 'Drug: Oxaliplatin', 'Drug: Capecitabine', 'Drug: S-1', 'Drug: Nivolumab']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'placebo+Nivolumab+chemotherapy', 'interventionNames': ['Drug: Oxaliplatin', 'Drug: Capecitabine', 'Drug: S-1', 'Drug: Nivolumab', 'Drug: Placebo']}], 'interventions': [{'name': 'ONO-4578', 'type': 'DRUG', 'description': 'Specified dose, once daily', 'armGroupLabels': ['ONO-4578+Nivolumab+chemotherapy']}, {'name': 'Oxaliplatin', 'type': 'DRUG', 'description': 'Specified dose on specified days', 'armGroupLabels': ['ONO-4578+Nivolumab+chemotherapy', 'placebo+Nivolumab+chemotherapy']}, {'name': 'Capecitabine', 'type': 'DRUG', 'description': 'Specified dose on specified days', 'armGroupLabels': ['ONO-4578+Nivolumab+chemotherapy', 'placebo+Nivolumab+chemotherapy']}, {'name': 'S-1', 'type': 'DRUG', 'otherNames': ['Tegafur-gimeracil-oteracil potassium'], 'description': 'Specified dose on specified days', 'armGroupLabels': ['ONO-4578+Nivolumab+chemotherapy', 'placebo+Nivolumab+chemotherapy']}, {'name': 'Nivolumab', 'type': 'DRUG', 'otherNames': ['Opdivo'], 'description': 'Specified dose on specified days', 'armGroupLabels': ['ONO-4578+Nivolumab+chemotherapy', 'placebo+Nivolumab+chemotherapy']}, {'name': 'Placebo', 'type': 'DRUG', 'description': 'Specified dose, once daily', 'armGroupLabels': ['placebo+Nivolumab+chemotherapy']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Nagoya', 'state': 'Aichi-ken', 'country': 'Japan', 'facility': 'Aichi Cancer Center Hospital', 'geoPoint': {'lat': 35.18147, 'lon': 136.90641}}, {'city': 'Kashiwa-shi', 'state': 'Chiba', 'country': 'Japan', 'facility': 'National Cancer Center Hospital East'}, {'city': 'Matsuyama', 'state': 'Ehime', 'country': 'Japan', 'facility': 'Matsuyama Red Cross Hospital', 'geoPoint': {'lat': 33.83916, 'lon': 132.76574}}, {'city': 'Matsuyama', 'state': 'Ehime', 'country': 'Japan', 'facility': 'NHO Shikoku Cancer Center', 'geoPoint': {'lat': 33.83916, 'lon': 132.76574}}, {'city': 'Fukuoka', 'state': 'Fukuoka', 'country': 'Japan', 'facility': 'Kyushu University Hospital', 'geoPoint': {'lat': 33.6, 'lon': 130.41667}}, {'city': 'Fukuoka', 'state': 'Fukuoka', 'country': 'Japan', 'facility': 'NHO Kyushu Cancer Center', 'geoPoint': {'lat': 33.6, 'lon': 130.41667}}, {'city': 'Yahatanishi-ku, Kitakyusyu-shi', 'state': 'Fukuoka', 'country': 'Japan', 'facility': 'JCHO Kyushu Hospital'}, {'city': 'Ota-shi', 'state': 'Gunma', 'country': 'Japan', 'facility': 'Gunma Prefectural Cancer Center'}, {'city': 'Hiroshima', 'state': 'Hiroshima', 'country': 'Japan', 'facility': 'Hiroshima City Hiroshima Citizens Hospital', 'geoPoint': {'lat': 34.4, 'lon': 132.45}}, {'city': 'Akashi-shi', 'state': 'Hyōgo', 'country': 'Japan', 'facility': 'Hyogo Cancer Center'}, {'city': 'Amagasaki-shi', 'state': 'Hyōgo', 'country': 'Japan', 'facility': 'JOHAS Kansai Rosai Hospital'}, {'city': 'Kobe', 'state': 'Hyōgo', 'country': 'Japan', 'facility': 'Kobe City Hospital Organization Kobe City Medical Center General Hospital', 'geoPoint': {'lat': 34.6913, 'lon': 135.183}}, {'city': 'Kasama-shi', 'state': 'Ibaraki', 'country': 'Japan', 'facility': 'Ibaraki Prefectural Central Hospital'}, {'city': 'Kanazawa', 'state': 'Ishikawa-ken', 'country': 'Japan', 'facility': 'Ishikawa Prefectural Central Hospital', 'geoPoint': {'lat': 36.6, 'lon': 136.61667}}, {'city': 'Yahaba-cho, Shiwa-gun', 'state': 'Iwate', 'country': 'Japan', 'facility': 'Iwate Medical University Hospital'}, {'city': 'Miki-cho, Kita-gun', 'state': 'Kagawa-ken', 'country': 'Japan', 'facility': 'Kagawa University Hospital'}, {'city': 'Sagamihara-shi', 'state': 'Kanagawa', 'country': 'Japan', 'facility': 'Kitasato University Hospital'}, {'city': 'Yokohama', 'state': 'Kanagawa', 'country': 'Japan', 'facility': 'Kanagawa Cancer Center', 'geoPoint': {'lat': 35.43333, 'lon': 139.65}}, {'city': 'Osaki-shi', 'state': 'Miyagi', 'country': 'Japan', 'facility': 'Osaki Citizen Hospital'}, {'city': 'Sendai', 'state': 'Miyagi', 'country': 'Japan', 'facility': 'Tohoku University Hospital', 'geoPoint': {'lat': 38.26667, 'lon': 140.86667}}, {'city': 'Kurashiki-shi', 'state': 'Okayama-ken', 'country': 'Japan', 'facility': 'Kurashiki Central Hospital'}, {'city': 'Chuo-ku', 'state': 'Osaka', 'country': 'Japan', 'facility': 'Osaka International Cancer Institute'}, {'city': 'Hirakata-shi', 'state': 'Osaka', 'country': 'Japan', 'facility': 'Kansai Medical University Hospital'}, {'city': 'Sayama-shi', 'state': 'Osaka', 'country': 'Japan', 'facility': 'Kindai University Hospital'}, {'city': 'Sumiyoshi-ku', 'state': 'Osaka', 'country': 'Japan', 'facility': 'Osaka General Medical Center'}, {'city': 'Takatsuki-shi', 'state': 'Osaka', 'country': 'Japan', 'facility': 'Osaka Medical and Pharmaceutical University Hospital'}, {'city': 'Ina-machi, Kitaadati-gun', 'state': 'Saitama', 'country': 'Japan', 'facility': 'Saitama Cancer Center'}, {'city': 'Nagaizumi-cho, Sunto-gun', 'state': 'Shizuoka', 'country': 'Japan', 'facility': 'Shizuoka Cancer Center'}, {'city': 'Koto-ku', 'state': 'Tokyo', 'country': 'Japan', 'facility': 'Cancer Institute Hospital of JFCR'}, {'city': 'Minato-Ku', 'state': 'Tokyo', 'country': 'Japan', 'facility': 'IMSUT Hospital, The Institute of Medical Science, The University 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'facility': 'Chungbuk National University Hospital', 'geoPoint': {'lat': 36.63722, 'lon': 127.48972}}, {'city': 'Busan', 'country': 'South Korea', 'facility': 'Dong-A University Hospital', 'geoPoint': {'lat': 35.10168, 'lon': 129.03004}}, {'city': 'Daegu', 'country': 'South Korea', 'facility': 'Keimyung University Dongsan Hospital', 'geoPoint': {'lat': 35.87028, 'lon': 128.59111}}, {'city': 'Daegu', 'country': 'South Korea', 'facility': 'Kyungpook National University Chilgok Hospital', 'geoPoint': {'lat': 35.87028, 'lon': 128.59111}}, {'city': 'Daegu', 'country': 'South Korea', 'facility': 'Yeungnam University Hospital', 'geoPoint': {'lat': 35.87028, 'lon': 128.59111}}, {'city': 'Incheon', 'country': 'South Korea', 'facility': 'Gachon University Gil Medical Center', 'geoPoint': {'lat': 37.45646, 'lon': 126.70515}}, {'city': 'Incheon', 'country': 'South Korea', 'facility': 'Inha University Hospital', 'geoPoint': {'lat': 37.45646, 'lon': 126.70515}}, {'city': 'Seoul', 'country': 'South Korea', 'facility': 'Asan Medical Center', 'geoPoint': {'lat': 37.566, 'lon': 126.9784}}, {'city': 'Seoul', 'country': 'South Korea', 'facility': 'Kangbuk Samsung Hospital', 'geoPoint': {'lat': 37.566, 'lon': 126.9784}}, {'city': 'Seoul', 'country': 'South Korea', 'facility': 'Korea University Guro Hospital', 'geoPoint': {'lat': 37.566, 'lon': 126.9784}}, {'city': 'Seoul', 'country': 'South Korea', 'facility': 'Kyung Hee University Hospital', 'geoPoint': {'lat': 37.566, 'lon': 126.9784}}, {'city': 'Seoul', 'country': 'South Korea', 'facility': 'Samsung Medical Center', 'geoPoint': {'lat': 37.566, 'lon': 126.9784}}, {'city': 'Seoul', 'country': 'South Korea', 'facility': 'Severance Hospital, Yonsei University Health System', 'geoPoint': {'lat': 37.566, 'lon': 126.9784}}, {'city': 'Seoul', 'country': 'South Korea', 'facility': "The Catholic University of Korea, Eunpyeong St. Mary's Hospital", 'geoPoint': {'lat': 37.566, 'lon': 126.9784}}, {'city': 'Ulsan', 'country': 'South Korea', 'facility': 'Ulsan University Hospital', 'geoPoint': {'lat': 35.53722, 'lon': 129.31667}}, {'city': 'Kaohsiung City', 'country': 'Taiwan', 'facility': 'Kaohsiung Medical University Chung-Ho Memorial Hospital', 'geoPoint': {'lat': 22.61626, 'lon': 120.31333}}, {'city': 'Taichung', 'country': 'Taiwan', 'facility': 'China Medical University Hospital', 'geoPoint': {'lat': 24.1469, 'lon': 120.6839}}, {'city': 'Tainan', 'country': 'Taiwan', 'facility': 'Chi Mei Hospital, Liouying', 'geoPoint': {'lat': 22.99083, 'lon': 120.21333}}, {'city': 'Tainan', 'country': 'Taiwan', 'facility': 'National Cheng Kung University Hospital', 'geoPoint': {'lat': 22.99083, 'lon': 120.21333}}, {'city': 'Taipei', 'country': 'Taiwan', 'facility': 'National Taiwan University Hospital', 'geoPoint': {'lat': 25.05306, 'lon': 121.52639}}, {'city': 'Taoyuan District', 'country': 'Taiwan', 'facility': 'Chang Gung Memorial Hospital, Linkou', 'geoPoint': {'lat': 24.9896, 'lon': 121.3187}}], 'overallOfficials': [{'name': 'Project Leader', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Ono Pharmaceutical Co. Ltd'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Ono Pharmaceutical Co. Ltd', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}