Ignite Creation Date:
2025-12-25 @ 3:03 AM
Ignite Modification Date:
2025-12-26 @ 1:43 AM
Study NCT ID:
NCT06031233
Status:
RECRUITING
Last Update Posted:
2025-05-21
First Post:
2023-04-24
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Evaluating the Safety of Shortened Infusion Times for dIfferent Oncological Immunotherapie
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D009369', 'term': 'Neoplasms'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D000077594', 'term': 'Nivolumab'}, {'id': 'C582435', 'term': 'pembrolizumab'}, {'id': 'D000074324', 'term': 'Ipilimumab'}, {'id': 'C000613593', 'term': 'durvalumab'}, {'id': 'C000594389', 'term': 'atezolizumab'}, {'id': 'D000068258', 'term': 'Bevacizumab'}, {'id': 'D000068878', 'term': 'Trastuzumab'}], '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': ['PHASE4'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NON_RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 679}}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2023-09-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-10', 'completionDateStruct': {'date': '2026-12', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-05-16', 'studyFirstSubmitDate': '2023-04-24', 'studyFirstSubmitQcDate': '2023-09-08', 'lastUpdatePostDateStruct': {'date': '2025-05-21', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2023-09-11', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2026-07', 'type': 'ESTIMATED'}}, 'outcomesModule': {'otherOutcomes': [{'measure': 'Satisfaction with shortened infusion time assessed by the VAS', 'timeFrame': 'Directly after infusion in fourth cycle (cycle length ranges from 21-42 days, depending on the specific antibody)', 'description': 'Scale 1-10, 1: not satisfied at all, 10: most satisfied'}], 'primaryOutcomes': [{'measure': 'Incidence of infusion related reactions', 'timeFrame': 'During or within 30 minutes after the end of the infusion'}], 'secondaryOutcomes': [{'measure': 'Plasma levels of the administered mAb', 'timeFrame': 'Within 15 minutes before start of the infusion'}]}, 'oversightModule': {'isUsExport': False, 'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Oncology', 'Infusion Reaction']}, 'descriptionModule': {'briefSummary': 'This study is an interventional, explorative, prospective study to show whether shortening of infusion times for patients using nivolumab, pembrolizumab, ipilimumab, trastuzumab, bevacizumab, durvalumab or atezolizumab continues to be associated with an acceptable safety profile.\n\nInfusion times will be gradually shortened if tolerability allowes.', 'detailedDescription': 'After two cycles with normal infusion times, infusion time will be shortened to 15 mintues en 10 minutes subsequently if no infusion reaction occurs.\n\nPatient satisfaction will be evaluated.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Starting treatment with monoclonal antibodies: nivolumab, pembrolizumab ipilimumab, bevacizumab, trastuzumab, durvalumab or atezolizumab.\n* 18 years and older.\n* No known history of increased susceptibility to immunological reactions.\n* Subject is able and willing to sign the Informed Consent Form prior to screening evaluations.\n\nExclusion Criteria:\n\n* Other research medication within 4 weeks of the start of the study.\n* Inclusion in medical research in which the administration of medication should follow its stated times and dosages of infusions\n* Dosage deviates from standard protocol\n* Patients whom receive drugs through a central venous catheter (and for example porth-a-cath).'}, 'identificationModule': {'nctId': 'NCT06031233', 'acronym': 'MINUTE', 'briefTitle': 'Evaluating the Safety of Shortened Infusion Times for dIfferent Oncological Immunotherapie', 'organization': {'class': 'OTHER', 'fullName': 'Isala'}, 'officialTitle': 'Evaluating the Safety of Shortened Infusion Times for dIfferent Oncological Immunotherapies; An Observational Prospective Study', 'orgStudyIdInfo': {'id': 'NL83071.075.22 / 20221102'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Nivolumab', 'description': 'If no infusion reaction has occurred after 2 cyclues, infusion time will stepwise be shortened to 10 minutes in the following cycles.', 'interventionNames': ['Drug: Nivolumab']}, {'type': 'EXPERIMENTAL', 'label': 'Pembrolizumab', 'description': 'If no infusion reaction has occurred after 2 cyclues, infusion time will stepwise be shortened to 10 minutes in the following cycles.', 'interventionNames': ['Drug: Pembrolizumab']}, {'type': 'EXPERIMENTAL', 'label': 'ipilimumab', 'description': 'If no infusion reaction has occurred after 2 cyclues, infusion time will stepwise be shortened to 10 minutes in the following cycles.', 'interventionNames': ['Drug: Ipilimumab']}, {'type': 'EXPERIMENTAL', 'label': 'Durvalumab', 'description': 'If no infusion reaction has occurred after 2 cyclues, infusion time will stepwise be shortened to 10 minutes in the following cycles.', 'interventionNames': ['Drug: Durvalumab']}, {'type': 'EXPERIMENTAL', 'label': 'Atezolizumab', 'description': 'If no infusion reaction has occurred after 2 cyclues, infusion time will stepwise be shortened to 10 minutes in the following cycles.', 'interventionNames': ['Drug: Atezolizumab']}, {'type': 'EXPERIMENTAL', 'label': 'bevacizumab', 'description': 'If no infusion reaction has occurred after 2 cyclues, infusion time will stepwise be shortened to 10 minutes in the following cycles.', 'interventionNames': ['Drug: Bevacizumab']}, {'type': 'EXPERIMENTAL', 'label': 'Trastuzumab', 'description': 'If no infusion reaction has occurred after 2 cyclues, infusion time will stepwise be shortened to 10 minutes in the following cycles.', 'interventionNames': ['Drug: Trastuzumab']}], 'interventions': [{'name': 'Nivolumab', 'type': 'DRUG', 'description': 'Gradual shortening of infusion times', 'armGroupLabels': ['Nivolumab']}, {'name': 'Pembrolizumab', 'type': 'DRUG', 'description': 'Gradual shortening of infusion times', 'armGroupLabels': ['Pembrolizumab']}, {'name': 'Ipilimumab', 'type': 'DRUG', 'description': 'Gradual shortening of infusion times', 'armGroupLabels': ['ipilimumab']}, {'name': 'Durvalumab', 'type': 'DRUG', 'description': 'Gradual shortening of infusion times', 'armGroupLabels': ['Durvalumab']}, {'name': 'Atezolizumab', 'type': 'DRUG', 'description': 'Gradual shortening of infusion times', 'armGroupLabels': ['Atezolizumab']}, {'name': 'Bevacizumab', 'type': 'DRUG', 'description': 'Gradual shortening of infusion times', 'armGroupLabels': ['bevacizumab']}, {'name': 'Trastuzumab', 'type': 'DRUG', 'description': 'Gradual shortening of infusion times', 'armGroupLabels': ['Trastuzumab']}]}, 'contactsLocationsModule': {'locations': [{'zip': '8025AB', 'city': 'Zwolle', 'status': 'RECRUITING', 'country': 'Netherlands', 'contacts': [{'name': 'Elianne CS de Boer', 'role': 'CONTACT', 'email': 'polioncologie@isala.nl', 'phone': '+31886245000'}], 'facility': 'Isala Hospital', 'geoPoint': {'lat': 52.5125, 'lon': 6.09444}}], 'centralContacts': [{'name': 'Elianne CS de Boer', 'role': 'CONTACT', 'email': 'polioncologie@isala.nl', 'phone': '+31886245000'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Isala', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Principal Investigator', 'investigatorFullName': 'HB Fiebrich-Westra', 'investigatorAffiliation': 'Isala'}}}}