Ignite Creation Date:
2025-12-25 @ 2:33 AM
Ignite Modification Date:
2025-12-26 @ 1:09 AM
Study NCT ID:
NCT03433534
Status:
COMPLETED
Last Update Posted:
2019-11-12
First Post:
2018-01-24
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Study of the Concentration-effect Relationship of Nivolumab in Patients With Kidney or Lung Cancer
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D007680', 'term': 'Kidney Neoplasms'}, {'id': 'D008175', 'term': 'Lung Neoplasms'}], 'ancestors': [{'id': 'D014571', 'term': 'Urologic Neoplasms'}, {'id': 'D014565', 'term': 'Urogenital Neoplasms'}, {'id': 'D009371', 'term': 'Neoplasms by Site'}, {'id': 'D009369', 'term': 'Neoplasms'}, {'id': 'D052776', 'term': 'Female Urogenital Diseases'}, {'id': 'D005261', 'term': 'Female Urogenital Diseases and Pregnancy Complications'}, {'id': 'D000091642', 'term': 'Urogenital Diseases'}, {'id': 'D007674', 'term': 'Kidney Diseases'}, {'id': 'D014570', 'term': 'Urologic Diseases'}, {'id': 'D052801', 'term': 'Male Urogenital Diseases'}, {'id': 'D012142', 'term': 'Respiratory Tract Neoplasms'}, {'id': 'D013899', 'term': 'Thoracic Neoplasms'}, {'id': 'D008171', 'term': 'Lung 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': {'bioSpec': {'retention': 'SAMPLES_WITHOUT_DNA', 'description': 'Blood samples will be drawn to all patients to measure nivolumab concentration'}, 'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 64}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2018-01-29', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2019-11', 'completionDateStruct': {'date': '2018-12-21', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2019-11-08', 'studyFirstSubmitDate': '2018-01-24', 'studyFirstSubmitQcDate': '2018-02-07', 'lastUpdatePostDateStruct': {'date': '2019-11-12', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2018-02-14', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2018-12-21', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Progression free survival', 'timeFrame': 'Up to one year', 'description': 'Association between nivolumab concentration and progression free survival : time from start of nivolumab treatment to progression'}], 'secondaryOutcomes': [{'measure': 'Overall survival', 'timeFrame': 'Up to one year', 'description': 'Association between nivolumab concentration and overall survival : time from start of nivolumab treatment to death'}, {'measure': 'Target concentration', 'timeFrame': '14 days', 'description': 'Determination of nivolumab concentration associated with clinical benefit (complete response + partial response + stable disease)'}, {'measure': 'Side effects', 'timeFrame': '14 days', 'description': 'Association between nivolumab residual concentration and side effects'}, {'measure': 'Nivolumab PK parameters : distribution volume', 'timeFrame': 'Baseline up to one year', 'description': 'Nivolumab residual concentrations will be measured each 14 days until the end of the study (up to one year).'}, {'measure': 'Nivolumab PK parameters : clearance', 'timeFrame': 'Baseline up to one year', 'description': 'Nivolumab residual concentrations will be measured each 14 days until the end of the study (up to one year).'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['nivolumab', 'monoclonal antibody', 'Opdivo', 'antineoplastic agent', 'ELISA', 'pharmacokinetic'], 'conditions': ['Kidney Cancer', 'Lung Cancer']}, 'descriptionModule': {'briefSummary': 'To assess the relationship between progression free survival of patients treated with nivolumab for metastatic non small cell lung carcinoma or a metastatic renal cell carcinoma and nivolumab blood concentration.\n\nCollection of standard data prospectively.', 'detailedDescription': 'Nivolumab is a monoclonal antibody used for the treatment of non small cell lung carcinoma and renal cell carcinoma. Huge variability exists between patients treated by nivolumab in terms of efficacy and side effects. Like others monoclonal antibodies, a relation between concentration and effects of nivolumab may exist.\n\nThe aim of this study is to assess the relationship between blood concentration of nivolumab and progression free survival, overall survival and side effects on the one hand, and on the other to describe pharmacokinetic of nivolumab'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Patients treated with nivolumab at CHRU of Tours for squamous or non squamous non small cell lung cancer stage IV or renal cell carcinoma stage IV', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Patient with squamous or non squamous non small cell lung cancer stage IV or patient with renal cell carcinoma stage IV\n* Patient receiving nivolumab or who will receive nivolumab\n* Age ⩾ 18 years old\n* OMS stage ≤ 2\n* Evaluable disease\n\nExclusion Criteria:\n\n* Active brain metastasis not treated before by surgery or radiotherapy\n* Autoimmune disease\n* Patient having objected to the processing of his data'}, 'identificationModule': {'nctId': 'NCT03433534', 'acronym': 'NIVEAL', 'briefTitle': 'Study of the Concentration-effect Relationship of Nivolumab in Patients With Kidney or Lung Cancer', 'organization': {'class': 'OTHER', 'fullName': 'University Hospital, Tours'}, 'officialTitle': 'Study of the Concentration-effect Relationship of Nivolumab in Patients With Kidney or Lung Cancer', 'orgStudyIdInfo': {'id': 'RIPH3-RNI17/NIVEAL'}, 'secondaryIdInfos': [{'id': '2017-A02788-45', 'type': 'OTHER', 'domain': 'IdRCB'}, {'id': '2017.12.08', 'type': 'OTHER', 'domain': 'CPP'}]}, 'armsInterventionsModule': {'armGroups': [{'label': 'Pharmacokinetic of Nivolumab', 'description': 'Patients under nivolumab (Opdivo 10 MG/ML) for the treatment of non small cell lung carcinoma or renal cell carcinoma. Measure of nivolumab residual concentration 14 days after administration of nivolumab and just before the new perfusion.', 'interventionNames': ['Other: Pharmacokinetic of Nivolumab']}], 'interventions': [{'name': 'Pharmacokinetic of Nivolumab', 'type': 'OTHER', 'otherNames': ['Opdivo'], 'description': 'Nivolumab residual concentration is measured 14 days after administration of nivolumab 3 mg/kg as an intravenous infusion just before the new administration.', 'armGroupLabels': ['Pharmacokinetic of Nivolumab']}]}, 'contactsLocationsModule': {'locations': [{'zip': '37044', 'city': 'Tours', 'country': 'France', 'facility': 'Medical oncology department, University Hospital, Tours', 'geoPoint': {'lat': 47.39484, 'lon': 0.70398}}, {'zip': '37044', 'city': 'Tours', 'country': 'France', 'facility': 'Pneumology department, University Hospital, Tours', 'geoPoint': {'lat': 47.39484, 'lon': 0.70398}}], 'overallOfficials': [{'name': 'Claude Linassier', 'role': 'STUDY_DIRECTOR', 'affiliation': 'University Hospital, Tours'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University Hospital, Tours', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}