Ignite Creation Date:
2025-12-24 @ 4:03 PM
Ignite Modification Date:
2026-02-24 @ 12:26 AM
Study NCT ID:
NCT05429866
Status:
UNKNOWN
Last Update Posted:
2023-03-08
First Post:
2022-04-24
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Immunological Variables Associated to ICI Toxicity in Cancer Patients
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D001943', 'term': 'Breast Neoplasms'}, {'id': 'D008545', 'term': 'Melanoma'}, {'id': 'D002289', 'term': 'Carcinoma, Non-Small-Cell Lung'}, {'id': 'D005770', 'term': 'Gastrointestinal Neoplasms'}, {'id': 'D006258', 'term': 'Head and Neck Neoplasms'}, {'id': 'D002292', 'term': 'Carcinoma, Renal Cell'}, {'id': 'D055752', 'term': 'Small Cell Lung Carcinoma'}, {'id': 'D000086002', 'term': 'Mesothelioma, Malignant'}, {'id': 'D001749', 'term': 'Urinary Bladder Neoplasms'}, {'id': 'D015266', 'term': 'Carcinoma, Merkel Cell'}, {'id': 'D006528', 'term': 'Carcinoma, Hepatocellular'}], 'ancestors': [{'id': 'D009371', 'term': 'Neoplasms by Site'}, {'id': 'D009369', 'term': 'Neoplasms'}, {'id': 'D001941', 'term': 'Breast Diseases'}, {'id': 'D012871', 'term': 'Skin Diseases'}, {'id': 'D017437', 'term': 'Skin and Connective Tissue Diseases'}, {'id': 'D018358', 'term': 'Neuroendocrine Tumors'}, {'id': 'D017599', 'term': 'Neuroectodermal Tumors'}, {'id': 'D009373', 'term': 'Neoplasms, Germ Cell and Embryonal'}, {'id': 'D009370', 'term': 'Neoplasms by Histologic Type'}, {'id': 'D009380', 'term': 'Neoplasms, Nerve Tissue'}, {'id': 'D018326', 'term': 'Nevi and Melanomas'}, {'id': 'D012878', 'term': 'Skin Neoplasms'}, {'id': 'D002283', 'term': 'Carcinoma, Bronchogenic'}, {'id': 'D001984', 'term': 'Bronchial Neoplasms'}, {'id': 'D008175', 'term': 'Lung Neoplasms'}, {'id': 'D012142', 'term': 'Respiratory Tract Neoplasms'}, {'id': 'D013899', 'term': 'Thoracic Neoplasms'}, {'id': 'D008171', 'term': 'Lung Diseases'}, {'id': 'D012140', 'term': 'Respiratory Tract Diseases'}, {'id': 'D004067', 'term': 'Digestive System Neoplasms'}, {'id': 'D004066', 'term': 'Digestive System Diseases'}, {'id': 'D005767', 'term': 'Gastrointestinal Diseases'}, {'id': 'D000230', 'term': 'Adenocarcinoma'}, {'id': 'D002277', 'term': 'Carcinoma'}, {'id': 'D009375', 'term': 'Neoplasms, Glandular and Epithelial'}, {'id': 'D007680', 'term': 'Kidney Neoplasms'}, {'id': 'D014571', 'term': 'Urologic Neoplasms'}, {'id': 'D014565', 'term': 'Urogenital 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': 'D008654', 'term': 'Mesothelioma'}, {'id': 'D000236', 'term': 'Adenoma'}, {'id': 'D018301', 'term': 'Neoplasms, Mesothelial'}, {'id': 'D010997', 'term': 'Pleural Neoplasms'}, {'id': 'D001745', 'term': 'Urinary Bladder Diseases'}, {'id': 'D027601', 'term': 'Polyomavirus Infections'}, {'id': 'D004266', 'term': 'DNA Virus Infections'}, {'id': 'D014777', 'term': 'Virus Diseases'}, {'id': 'D007239', 'term': 'Infections'}, {'id': 'D014412', 'term': 'Tumor Virus Infections'}, {'id': 'D018278', 'term': 'Carcinoma, Neuroendocrine'}, {'id': 'D008113', 'term': 'Liver Neoplasms'}, {'id': 'D008107', 'term': 'Liver Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D000082082', 'term': 'Immune Checkpoint Inhibitors'}, {'id': 'D000077594', 'term': 'Nivolumab'}, {'id': 'C000594389', 'term': 'atezolizumab'}, {'id': 'C000609138', 'term': 'avelumab'}, {'id': 'C000613593', 'term': 'durvalumab'}, {'id': 'C000627974', 'term': 'cemiplimab'}], 'ancestors': [{'id': 'D045504', 'term': 'Molecular Mechanisms of Pharmacological Action'}, {'id': 'D020228', 'term': 'Pharmacologic Actions'}, {'id': 'D020164', 'term': 'Chemical Actions and Uses'}, {'id': 'D000074322', 'term': 'Antineoplastic Agents, Immunological'}, {'id': 'D000970', 'term': 'Antineoplastic Agents'}, {'id': 'D045506', 'term': 'Therapeutic Uses'}, {'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': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'OTHER', 'interventionModel': 'SINGLE_GROUP', 'interventionModelDescription': 'This is a monocentric, prospective, pilot study that will enrol 435 subjects with solid tumours that are treated with immune checkpoint inhibitor(s) (ICI) alone or in combination with chemotherapy or targeted therapy.'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 441}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'RECRUITING', 'startDateStruct': {'date': '2022-09-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2023-03', 'completionDateStruct': {'date': '2024-12-01', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2023-03-07', 'studyFirstSubmitDate': '2022-04-24', 'studyFirstSubmitQcDate': '2022-06-22', 'lastUpdatePostDateStruct': {'date': '2023-03-08', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2022-06-23', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2024-06-01', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Modification(s) in the immune blood markers of treated subjects on treatment.', 'timeFrame': 'Assessment: between week 4 and 6 after the first dose of the treatment', 'description': 'Modification(s) in the immune blood markers including cytokines, immune cells and serum autoantibody level of treated subjects.'}, {'measure': 'Modification(s) in the immune blood markers of treated subjects on treatment.', 'timeFrame': 'Assessment: between week 8 and 11 after the first dose of the treatment', 'description': 'Modification(s) in the immune blood markers including cytokines, immune cells and serum autoantibody level of treated subjects.'}, {'measure': 'Modification(s) in the immune blood markers of treated subjects on treatment.', 'timeFrame': 'Assessment: between week 13-18 after the first dose of the treatment', 'description': 'Modification(s) in the immune blood markers including cytokines, immune cells and serum autoantibody level of treated subjects.'}, {'measure': 'Modification(s) in the immune blood markers of treated subjects on treatment at the occurence of any grade 1 or 2 irAE.', 'timeFrame': 'Assessment: Day1 after diagnostic of any grade 1 or 2 irAE', 'description': 'Safety will be assessed and graded by the investigator(s) by using the adverse events reported during the study in accordance with the National Cancer Institute Common Terminology Criteria for Adverse Events (CTCAE) Version 5.0.'}, {'measure': 'Modification(s) in the immune blood markers of treated subjects on treatment at the occurence of any grade 3 or 4 irAE.', 'timeFrame': 'Assessment: Day one after diagnostic of any grade 3 or 4 irAE', 'description': 'Safety will be assessed and graded by the investigator(s) by using the adverse events reported during the study in accordance with the National Cancer Institute Common Terminology Criteria for Adverse Events (CTCAE) Version 5.0.'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Breast Cancer', 'Melanoma', 'Non Small Cell Lung Cancer', 'Non-melanoma Skin Cancer', 'Gastrointestinal Cancer', 'Head and Neck Cancer', 'Renal Cell Carcinoma', 'Small Cell Lung Cancer', 'Mesothelioma, Malignant', 'Bladder Cancer', 'Merkel Cell Carcinoma', 'Hepatocellular Carcinoma', 'MSI-H Colorectal Cancer']}, 'descriptionModule': {'briefSummary': 'This is a monocentric, prospective, pilot study that will enrol 435 subjects with solid tumours that are treated with immune checkpoint inhibitor(s) (ICI) alone or in combination with chemotherapy or targeted therapy.\n\nFor enrolled subjects, clinical and laboratory evaluations will be performed and reported at different time points:\n\n* Early (4-6 weeks after treatment start)\n* Midtime (8-11 weeks after treatment start)\n* Late (13-18 weeks after treatment start)\n* At the occurrence of immune-related adverse events (irAEs), clinical and laboratory evaluation will be performed at two principal time points:\n\n * For the 1st time of any grade 1 or 2 irAE if the subject developed it.\n * For the 1st time of any grade 3 or 4 irAE if the subject developed it.', 'detailedDescription': 'Advances in treating patients with immunotherapy has dramatically changed cancer morbidity and mortality. Immune checkpoint inhibitors (ICI), alone or combined with other drugs, are currently used both as standard of care or in experimental settings for various cancers. Currently, ICI treatment induces objective clinical responses in 20-40% of patients, which varies by tumour type. A significant risk of immune-related adverse events (irAE) is also associated with ICI treatment, including the onset of autoimmune diseases. While the incidence of irAE is highly variable and influenced by many factors, phase I and II trials reported rates from 10% to 80% for any grade irAE while an irAE of grade 3 or higher was observed in 2.5% to 18% of subjects. Despite the fact that older adults represent the growing majority of patients diagnosed with cancer, the efficacy and toxicity of ICI in older patients, alone or in combination with other agents, remains controversial. Presently, the specific immune mechanism(s) driving irAE are unknown and biomarkers that predict their onset, particularly high-grade irAE, are urgently needed. The identification of predictive clinical, laboratory and immunological biomarkers (blood and tissue) for toxicity will more accurately identify and quantify patients who are at risk for ICI therapy. Then, this will possibly allow better irAE management.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': "Inclusion Criteria:\n\n* 1\\) Age ≥ 18 years old\n* 2\\) ECOG performance status ≤ 1\n* 3\\) Must have histologically or cytologically confirmed solid tumour, eligible for treatment with ICI as standard-of-care alone or in combination with another ICI (cohort 1), ICI with chemotherapy (cohort 2), or ICI with targeted therapy (cohort 3) with no restrictions on number of prior systemic therapies\n* 4\\) All prior anti-cancer treatment-related toxicities (except alopecia) must be ≤ Grade 1 according to the Common Terminology Criteria for Adverse Events (CTCAE) version 5.0 at the time of enrolment\n* 5\\) Serum pregnancy test (for subjects of childbearing potential) negative within 15 days prior to study medications administration.\n* 6\\) Women of childbearing potential must agree to use one highly effective method of contraception prior study entry, during the course of the study and at least 7 months after the last administration of study treatments.\n* 7\\) Men with childbearing potential partner must agree to use condom during the course of this study and for at least 6 months after the last administration of the study treatments.\n* 8\\) Completion of all necessary screening procedures within 14 days prior to enrolment.\n* 9\\) Signed Informed Consent form (ICF) obtained prior to any study related procedure.\n\nExclusion Criteria:\n\n* Subjects meeting one of the following criteria are not eligible for this study:\n\n 1. Subject with a significant medical, neuro-psychiatric, or surgical condition, currently uncontrolled by treatment, which, in the principal investigator's opinion, may interfere with completion of the study.\n 2. Participation in another clinical trial.\n 3. Pregnant and/or lactating women.\n 4. Subjects already receiving ICI."}, 'identificationModule': {'nctId': 'NCT05429866', 'briefTitle': 'Immunological Variables Associated to ICI Toxicity in Cancer Patients', 'organization': {'class': 'OTHER', 'fullName': 'Jules Bordet Institute'}, 'officialTitle': 'Immunological Variables Associated to ICI Toxicity in Cancer Patients', 'orgStudyIdInfo': {'id': 'IJB-IRAES-2020'}}, 'armsInterventionsModule': {'interventions': [{'name': 'Checkpoint Blockade, Immune', 'type': 'DRUG', 'otherNames': ['Ipililumab', 'Nivolumab', 'Pembrozilumab', 'atezolizumab', 'avelumab', 'durvalumab', 'Cemiplimab'], 'description': 'Immune checkpoint blockade drugs target the immune system by blocking control pathways regulating anti-tumor immunity and thereby reinvigorate their activities against cancer.'}]}, 'contactsLocationsModule': {'locations': [{'zip': '1070', 'city': 'Brussels', 'state': 'Anderlecht', 'status': 'RECRUITING', 'country': 'Belgium', 'contacts': [{'name': 'MIREILLE LANGOUO, MD, PhD', 'role': 'CONTACT', 'email': 'mireille.langouo@bordet.be', 'phone': '0032(2)5413377'}], 'facility': 'Institut Jules Bordet', 'geoPoint': {'lat': 50.85045, 'lon': 4.34878}}], 'centralContacts': [{'name': 'mireille Langouo Fontsa, MD', 'role': 'CONTACT', 'email': 'mireille.langouo@bordet.be', 'phone': '0032 (0) 484729928'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Jules Bordet Institute', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Principal investigator', 'investigatorFullName': 'Mireille Langouo Fontsa', 'investigatorAffiliation': 'Jules Bordet Institute'}}}}