Ignite Creation Date:
2025-12-25 @ 3:55 AM
Ignite Modification Date:
2025-12-26 @ 2:45 AM
Study NCT ID:
NCT04749602
Status:
COMPLETED
Last Update Posted:
2023-03-08
First Post:
2021-02-07
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Intrapleural Instillation of the Nivolumab in Cancer Patients With Pleural Effusion.
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D016066', 'term': 'Pleural Effusion, Malignant'}], 'ancestors': [{'id': 'D010997', 'term': 'Pleural Neoplasms'}, {'id': 'D012142', 'term': 'Respiratory Tract Neoplasms'}, {'id': 'D013899', 'term': 'Thoracic Neoplasms'}, {'id': 'D009371', 'term': 'Neoplasms by Site'}, {'id': 'D009369', 'term': 'Neoplasms'}, {'id': 'D010996', 'term': 'Pleural Effusion'}, {'id': 'D010995', 'term': 'Pleural Diseases'}, {'id': 'D012140', 'term': 'Respiratory Tract Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'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': ['PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NON_RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL', 'interventionModelDescription': 'Cohort 1 (renal cell carcinoma / lung cancer) Cohort 2 (lung cancer)'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 26}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2020-08-10', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2023-03', 'completionDateStruct': {'date': '2023-03-01', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2023-03-06', 'studyFirstSubmitDate': '2021-02-07', 'studyFirstSubmitQcDate': '2021-02-07', 'lastUpdatePostDateStruct': {'date': '2023-03-08', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2021-02-11', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2023-03-01', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': '3-month recurrence-free survival', 'timeFrame': '3 months', 'description': 'Proportion of patients who will be without signs of radiographic recurrence after 3 months'}], 'secondaryOutcomes': [{'measure': 'Rate of any grade adverse events', 'timeFrame': '3 months', 'description': 'Percentage of patients who will experience any grade adverse events (according to CTCAE criteria ver. 5.0) associated with intrapleural nivolumab use'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Nivolumab', 'Intrapleural irrigation', 'Pleural carcinomatosis'], 'conditions': ['Renal Cell Cancer Metastatic', 'Non-small Cell Lung Cancer Metastatic', 'Pleural Effusion, Malignant']}, 'descriptionModule': {'briefSummary': 'Patients with advanced cancers who have pleural effusion, especially those requiring pleural evacuation, experienced poorer survival when treated with immunotherapy. The pleura also acts as a natural barrier that can limit the penetration of immune checkpoint inhibitors. In this multicenter phase 2 study, the preliminary efficacy and toxicity of intrapleural instillation of the nivolumab in patients with immune-sensitive metastatic cancers will be accessed.', 'detailedDescription': 'Patients ≥18 years old who have large volume of pleural effusion, required evacuation, and received systemic therapy with a checkpoint inhibitor (monotherapy or combination with another checkpoint inhibitor) for metastatic cancers (renal cell carcinoma (RCC) and non-small cell lung cancer (NSCLC) will be eligible. Drainage followed by nivolumab (40 mg, single intrapleural instillation) will be performed.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Patients ≥18 years old\n* Large volume of pleural effusion (1 liter and more), required evacuation\n* Systemic therapy with a checkpoint inhibitor (monotherapy or combination with another checkpoint inhibitor)\n* Metastatic cancers (renal cell carcinoma (RCC) and non-small cell lung cancer (NSCLC)\n\nExclusion Criteria:\n\n* Autoimmune disorders\n* Previous treatment for'}, 'identificationModule': {'nctId': 'NCT04749602', 'briefTitle': 'Intrapleural Instillation of the Nivolumab in Cancer Patients With Pleural Effusion.', 'organization': {'class': 'OTHER', 'fullName': 'Kidney Cancer Research Bureau'}, 'officialTitle': 'A Phase II Trial of Intrapleural Instillation of the Nivolumab in Cancer Patients With Pleural Effusion.', 'orgStudyIdInfo': {'id': 'KCRB-Hadassah-01'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Cohort 1: Intrapleural Nivolumab in patients with renal cell carcinoma', 'description': 'Drainage followed by nivolumab (40 mg, single intrapleural instillation) will be performed.', 'interventionNames': ['Drug: Nivolumab']}, {'type': 'EXPERIMENTAL', 'label': 'Cohort 2: Intrapleural Nivolumab in patients with non-small cell lung cancer', 'description': 'Drainage followed by nivolumab (40 mg, single intrapleural instillation) will be performed.', 'interventionNames': ['Drug: Nivolumab']}], 'interventions': [{'name': 'Nivolumab', 'type': 'DRUG', 'otherNames': ['Opdivo'], 'description': '40 mg of the nivolumab will be used intrapleurally (once).', 'armGroupLabels': ['Cohort 1: Intrapleural Nivolumab in patients with renal cell carcinoma', 'Cohort 2: Intrapleural Nivolumab in patients with non-small cell lung cancer']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Moscow', 'country': 'Russia', 'facility': 'I.M. Sechenov First Moscow State Medical University', 'geoPoint': {'lat': 55.75204, 'lon': 37.61781}}, {'city': 'Moscow', 'country': 'Russia', 'facility': 'Kidney Cancer Research Bureau', 'geoPoint': {'lat': 55.75204, 'lon': 37.61781}}, {'city': 'Moscow', 'country': 'Russia', 'facility': 'Medicine 24/7 clinic', 'geoPoint': {'lat': 55.75204, 'lon': 37.61781}}, {'city': 'Moscow', 'country': 'Russia', 'facility': 'Medscan', 'geoPoint': {'lat': 55.75204, 'lon': 37.61781}}, {'city': 'Moscow', 'country': 'Russia', 'facility': 'Yauza clinical hospital', 'geoPoint': {'lat': 55.75204, 'lon': 37.61781}}], 'overallOfficials': [{'name': 'Ilya Tsimafeyeu, M.D.', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Kidney Cancer Research Bureau'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Kidney Cancer Research Bureau', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}