Ignite Creation Date:
2025-12-24 @ 1:49 PM
Ignite Modification Date:
2026-02-12 @ 11:50 PM
Study NCT ID:
NCT02999295
Status:
COMPLETED
Last Update Posted:
2019-08-21
First Post:
2016-12-19
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
A Phase 1/2 Study of Ramucirumab Plus Nivolumab in Participants With Gastric or GEJ Cancer
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D013274', 'term': 'Stomach Neoplasms'}, {'id': 'D009369', 'term': 'Neoplasms'}], 'ancestors': [{'id': 'D005770', 'term': 'Gastrointestinal Neoplasms'}, {'id': 'D004067', 'term': 'Digestive System Neoplasms'}, {'id': 'D009371', 'term': 'Neoplasms by Site'}, {'id': 'D004066', 'term': 'Digestive System Diseases'}, {'id': 'D005767', 'term': 'Gastrointestinal Diseases'}, {'id': 'D013272', 'term': 'Stomach Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D000096662', 'term': 'Ramucirumab'}, {'id': 'D000077594', 'term': 'Nivolumab'}], 'ancestors': [{'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': ['PHASE1', 'PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NON_RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 46}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2017-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2019-08', 'completionDateStruct': {'date': '2019-08', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2019-08-19', 'studyFirstSubmitDate': '2016-12-19', 'studyFirstSubmitQcDate': '2016-12-19', 'lastUpdatePostDateStruct': {'date': '2019-08-21', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2016-12-21', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2017-11', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Number of participants with dose limiting toxicities (DLTs)', 'timeFrame': 'Phase 1, course 1 (up to 28 days)', 'description': 'Number of participants with dose limiting toxicities (DLTs)'}, {'measure': 'Progression free survival rate after 6 months', 'timeFrame': 'from baseline to 6 months', 'description': 'Progression free survival rate after 6 months'}], 'secondaryOutcomes': [{'measure': 'Number of participants with adverse events', 'timeFrame': 'from baseline to date of treatment cessation, approximately 24 months', 'description': 'Number of participants with adverse events'}, {'measure': 'Objective response rate (ORR)', 'timeFrame': 'from baseline to date of disease progression, approximately 24 months', 'description': 'percentage of participants with with a best response of complete response (CR) or partial response (PR)'}, {'measure': 'Disease control rate (DCR)', 'timeFrame': 'from baseline to date of disease progression, approximately 24 months', 'description': 'percentage of participants with with a best response of CR, PR or stable disease (SD)'}, {'measure': 'Overall survival (OS)', 'timeFrame': 'from baseline to date of death, approximately 24 months', 'description': 'Overall survival (OS)'}, {'measure': 'Progression free survival (PFS)', 'timeFrame': 'from baseline to date of disease progression or death, approximately 24 months', 'description': 'Progression free survival (PFS)'}]}, 'conditionsModule': {'conditions': ['Gastric Cancer', 'Gastroesophageal Junction Region (GEJ) Cancer']}, 'descriptionModule': {'briefSummary': 'The main purpose of this study is to evaluate the safety and efficacy of the combination therapy of ramucirumab and nivolumab in participants with advanced or recurrent unresectable gastric or GEJ cancer.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '20 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Advanced or recurrent unresectable gastric or GEJ cancer\n* Histologically confirmed adenocarcinoma (papillary adenocarcinoma, tubular adenocarcinoma or poorly differentiated adenocarcinoma), signet-ring cell carcinoma, mucinous adenocarcinoma or hepatoid adnocarcinoma\n* Patients with normal oral intake\n* Eastern Cooperative Oncology Group (ECOG) performance status 0 or 1\n* Patients who have measurable target lesion\n* Patients has a refractory or intolerant pretreatment by pyrimidine fluoride anticancer agent and platinum-based anticancer agent\n* Patients with adequate organ function\n* Patients with no pretreatment history including ramucirumab, nivolumab or other therapies targeting control of T cells\n* Patients with written informed consent\n\nExclusion Criteria:\n\n* Patients have double cancer\n* Patients have infection required systemic therapy\n* Known central vervous system (CNS) metastasis\n* Patients with history of pneumonitis or pulmonary fibrosis\n* Patients with history of serious anaphylaxis induced by antibody preparation\n* Patients who have known active autoimmune disease or history of chronic recurrent autoimmune disease\n* Female who is pregnant, lactating or suspected pregnancy\n* Patients with psychosis or dementia to interfere to obtain informed consent appropriately'}, 'identificationModule': {'nctId': 'NCT02999295', 'briefTitle': 'A Phase 1/2 Study of Ramucirumab Plus Nivolumab in Participants With Gastric or GEJ Cancer', 'organization': {'class': 'OTHER_GOV', 'fullName': 'National Cancer Center, Japan'}, 'officialTitle': 'A Multicenter, Phase 1/2 Study of Ramucirumab Plus Nivolumab as Second-line Therapy in Participants With Gastric or GEJ Cancer', 'orgStudyIdInfo': {'id': 'NCCH-1611'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Phase 1', 'description': 'Ramucirumab: 8 mg/kg, every two week Nivolumab: 3.0 mg/kg or 1.0 mg/kg (optional), every two weeks', 'interventionNames': ['Biological: Ramucirumab', 'Biological: Nivolumab']}, {'type': 'EXPERIMENTAL', 'label': 'Phase 2', 'description': 'Ramucirumab: 8 mg/kg, every two week Nivolumab: recommended dose established in the phase 1, every two weeks', 'interventionNames': ['Biological: Ramucirumab', 'Biological: Nivolumab']}], 'interventions': [{'name': 'Ramucirumab', 'type': 'BIOLOGICAL', 'otherNames': ['LY3009806'], 'description': 'Ramucirumab (8 mg/kg) is administered.', 'armGroupLabels': ['Phase 1', 'Phase 2']}, {'name': 'Nivolumab', 'type': 'BIOLOGICAL', 'otherNames': ['ONO-4538'], 'description': 'Nivolumab (3.0 mg/kg or 1.0 mg/kg) is administered.', 'armGroupLabels': ['Phase 1', 'Phase 2']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Tokyo', 'country': 'Japan', 'facility': 'National Cancer Center Hospital', 'geoPoint': {'lat': 35.6895, 'lon': 139.69171}}], 'overallOfficials': [{'name': 'Ken Kato, M.D. / Ph.D.', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Department of Gastrointestinal Medical Oncology, National cancer center hospital'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'National Cancer Center, Japan', 'class': 'OTHER_GOV'}, 'collaborators': [{'name': 'Ono Pharmaceutical Co. Ltd', 'class': 'INDUSTRY'}, {'name': 'Fiverings Co., Ltd.', 'class': 'OTHER'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Head Physician', 'investigatorFullName': 'Ken Kato', 'investigatorAffiliation': 'National Cancer Center, Japan'}}}}