Ignite Creation Date:
2025-12-24 @ 5:41 PM
Ignite Modification Date:
2026-01-22 @ 1:41 PM
Study NCT ID:
NCT04268368
Status:
UNKNOWN
Last Update Posted:
2020-02-17
First Post:
2020-02-10
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Immune Related-adverse Events in Patients Receiving Immune Checkpoint Inhibitors
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D009369', 'term': 'Neoplasms'}, {'id': 'D008175', 'term': 'Lung Neoplasms'}, {'id': 'D002292', 'term': 'Carcinoma, Renal Cell'}, {'id': 'D008545', 'term': 'Melanoma'}], 'ancestors': [{'id': 'D012142', 'term': 'Respiratory Tract Neoplasms'}, {'id': 'D013899', 'term': 'Thoracic Neoplasms'}, {'id': 'D009371', 'term': 'Neoplasms by Site'}, {'id': 'D008171', 'term': 'Lung Diseases'}, {'id': 'D012140', 'term': 'Respiratory Tract Diseases'}, {'id': 'D000230', 'term': 'Adenocarcinoma'}, {'id': 'D002277', 'term': 'Carcinoma'}, {'id': 'D009375', 'term': 'Neoplasms, Glandular and Epithelial'}, {'id': 'D009370', 'term': 'Neoplasms by Histologic Type'}, {'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': 'D018358', 'term': 'Neuroendocrine Tumors'}, {'id': 'D017599', 'term': 'Neuroectodermal Tumors'}, {'id': 'D009373', 'term': 'Neoplasms, Germ Cell and Embryonal'}, {'id': 'D009380', 'term': 'Neoplasms, Nerve Tissue'}, {'id': 'D018326', 'term': 'Nevi and Melanomas'}, {'id': 'D012878', 'term': 'Skin Neoplasms'}, {'id': 'D012871', 'term': 'Skin Diseases'}, {'id': 'D017437', 'term': 'Skin and Connective Tissue Diseases'}]}}, 'protocolSection': {'designModule': {'bioSpec': {'retention': 'SAMPLES_WITH_DNA', 'description': 'Whole blood samples will be collected for the preparation of serum and plasma at the baseline visit and at follow-up visits for all patients.'}, 'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 200}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'RECRUITING', 'startDateStruct': {'date': '2019-01-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2020-02', 'completionDateStruct': {'date': '2022-01-01', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2020-02-13', 'studyFirstSubmitDate': '2020-02-10', 'studyFirstSubmitQcDate': '2020-02-10', 'lastUpdatePostDateStruct': {'date': '2020-02-17', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2020-02-13', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2021-01-01', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Incidence of irAEs', 'timeFrame': '24 months', 'description': 'To determine the incidence and the characteristics of irAEs in a real-world setting'}, {'measure': 'Risk factors for irAEs', 'timeFrame': '24 months', 'description': 'To determine the risk factors for the development of irAEs'}, {'measure': 'Impact of irAEs', 'timeFrame': '24 months', 'description': "To determine the impact of irAEs on patients' prognosis"}, {'measure': 'Therapies of irAEs', 'timeFrame': '24 months', 'description': "To determine the effect of immunosuppressive therapies on tumor progression and patient's prognosis"}], 'secondaryOutcomes': [{'measure': 'Clinical care pathway', 'timeFrame': '24 months', 'description': 'To set up an integrated clinical care pathway for cancer patients that developed an irAE following immune checkpoint inhibitor administration'}, {'measure': 'Quality of life', 'timeFrame': '24 months', 'description': 'The quality of life will be measured by means of the European Organization for Research and Treatment of Cancer quality of life questionnaire (EORTC QLQ-C30). It is composed by five functional scales, three symptom scales, a global health status / QoL scale, and six single items. All of the scales and single-item measures range in score from 0 to 100. A high scale score represents a higher response level.'}, {'measure': 'Biomarkers', 'timeFrame': '24 months', 'description': 'To evaluate potential biomarkers that may predict the development of irAEs and/or the response to treatment in biological samples from cancer patients treated with immune checkpoint inhibitors'}, {'measure': 'Exploratory analyses', 'timeFrame': '24 months', 'description': 'To get better insights on the biological basis of irAEs the response to treatment in biological samples from cancer patients treated with immune checkpoint inhibitors'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['cancer', 'immune checkpoint inhibitors', 'immune related adverse events', 'nivolumab', 'pembrolizumab', 'avelumab', 'durvalumab', 'atezolizumab'], 'conditions': ['Cancer', 'Lung Cancer', 'Renal Cell Carcinoma', 'Melanoma']}, 'referencesModule': {'references': [{'pmid': '29442540', 'type': 'BACKGROUND', 'citation': 'Brahmer JR, Lacchetti C, Schneider BJ, Atkins MB, Brassil KJ, Caterino JM, Chau I, Ernstoff MS, Gardner JM, Ginex P, Hallmeyer S, Holter Chakrabarty J, Leighl NB, Mammen JS, McDermott DF, Naing A, Nastoupil LJ, Phillips T, Porter LD, Puzanov I, Reichner CA, Santomasso BD, Seigel C, Spira A, Suarez-Almazor ME, Wang Y, Weber JS, Wolchok JD, Thompson JA; National Comprehensive Cancer Network. Management of Immune-Related Adverse Events in Patients Treated With Immune Checkpoint Inhibitor Therapy: American Society of Clinical Oncology Clinical Practice Guideline. J Clin Oncol. 2018 Jun 10;36(17):1714-1768. doi: 10.1200/JCO.2017.77.6385. Epub 2018 Feb 14.'}]}, 'descriptionModule': {'briefSummary': 'The recent introduction of anti-PD-1 (nivolumab and pembrolizumab) and anti- PD-L1 (atezolizumab, durvalumab, avelumab) immune checkpoint inhibitors revolutionized oncological guidelines. Durable responses and prolongation of survival with these agents come at the price of the development of immune related adverse events (irAEs). Innovative tools are required in order to manage irAEs and to prevent their potential relapse, with the goal to improve the outcome of patients. In this regard, the Investigators aim to develop a multidisciplinary clinical pathway for cancer patients that are treated with immune checkpoint inhibitors.', 'detailedDescription': "Recent evidences in immuno-oncology showed an important role of the immune system in tumor control. In fact, immune response, both innate and adaptive one, is the first defensive mechanism against cancer. However, several tumors, during their progression, develop an immune-tolerance characterized by the activation of immune inhibitory pathways including PD-1 and PD-L1.\n\nThe recent introduction of anti-PD-1 (nivolumab and pembrolizumab) and anti-PD-L1 (atezolizumab, durvalumab, avelumab) immune checkpoint inhibitors revolutionized oncological guidelines.\n\nCurrently, the aforementioned agents are approved for the treatment of advanced malignant melanoma; non-small cell lung cancer (NSCLC) and renal cell carcinoma (RCC) and the number of treatment indications for immune checkpoint inhibitors is expanding. Durable responses and prolongation of survival with these agents come at the price of the development of immune-related adverse events (irAEs).\n\nImmune-related adverse events are due to the loss of immune-tolerance towards structures of the self, with the induction of chronic inflammation with an autoimmune mechanism that can involve numerous organs and systems. The most frequent irAEs reported in clinical trials are represented by skin toxicity, gastrointestinal toxicity, endocrine toxicity, pulmonary toxicity, and others such as polymyalgia rheumatica, polyarthritis, myositis, nephritis, polyradiculoneuritis, encephalitis and myocarditis.\n\nThe irAEs reported in clinical trials with nivolumab amount to a maximum of 85% considering all grade of toxicities, while approximately 75% of patients treated with pembrolizumab presented irAEs. Grade 3/4 irAEs were reported in 10% of patients treated with anti-PD-1. With atezolizumab fewer patients had treatment-related grade 3 or 4 adverse events (15%).\n\nIn most cases, irAEs occur within some weeks after starting of immunotherapy; however these toxicities have been reported later and also years after treatment discontinuation. The development of irAEs is associated with significant morbidity and mortality in cancer patients treated with immune checkpoint inhibitors, and therefore they may significantly affect the quality of life, even in patients achieve the control of neoplastic disease.\n\nThe overseeing, early diagnosis and clinical management of immune checkpoint inhibitors' toxicities in the clinical setting are, currently, not standardized.\n\nInnovative tools are required in order to manage irAEs and to prevent their potential relapse, with the goal to improve the outcome and quality of life of these patients.\n\nIn this regard, the Investigators also aim to evaluate a model of multidisciplinary clinical pathway for cancer patients that are treated with immune checkpoint inhibitors in order to improve their management and also ameliorate the quality of life of patients that develop irAEs."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Patients referring to the Oncology and Hematology Clinics of the Azienda Ospedaliero- Universitaria Ospedali Riuniti di Ancona (Italy) may be enrolled.', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n1. Adult patients above 18 years of age;\n2. Cyto-histological diagnosis of one of the following cancers:\n\n 1. advanced melanoma;\n 2. metastatic or locally advanced non-small cell lung cancer;\n 3. advanced renal cell carcinoma;\n 4. metastatic or locally advanced urotelial carcinoma;\n 5. squamous cell carcinoma of the head and neck;\n 6. Hodgkin lymphoma;\n 7. Merkel-cell carcinoma;\n3. New prescription of one of the following PD-1/PD-L1 inhibitors:\n\n 1. nivolumab\n 2. pembrolizumab\n 3. atezolizumab\n 4. avelumab\n 5. durvalumab alone or in combination therapy, following the indications of the Italian regulatory agency (AIFA).\n\nExclusion Criteria:\n\n1. Patients that refuse and/or are not able to sign the Informed Consent;\n2. Parents/guardians or subjects who, in the opinion of the Investigator, may be noncompliant with study schedules or procedures;\n3. No contraindications to the treatment with PD-1/PD-L1 antibodies, following the indications of the Italian regulatory agency (AIFA).\n\nSubjects that do not meet all of the enrollment criteria may not be enrolled.'}, 'identificationModule': {'nctId': 'NCT04268368', 'acronym': 'ICI-DISCOVER', 'briefTitle': 'Immune Related-adverse Events in Patients Receiving Immune Checkpoint Inhibitors', 'organization': {'class': 'OTHER', 'fullName': 'Università Politecnica delle Marche'}, 'officialTitle': 'Incidence, Clinical Management and Molecular Factors Associated With the Development of Immune-related Adverse Events in Cancer Patients Receiving PD-1 and PD-L1 Inhibitors: a Prospective Observational Study', 'orgStudyIdInfo': {'id': 'ICI-DISCOVER'}}, 'contactsLocationsModule': {'locations': [{'zip': '60020', 'city': 'Ancona', 'state': 'AN', 'status': 'RECRUITING', 'country': 'Italy', 'contacts': [{'name': 'Armando Gabrielli, MD, professor', 'role': 'CONTACT', 'email': 'a.gabrielli@staff.univpm.it', 'phone': '0712206104', 'phoneExt': '0039'}, {'name': 'Giovanni Pomponio, MD', 'role': 'CONTACT', 'email': 'pomponio@univpm.it', 'phone': '0715964205', 'phoneExt': '0039'}], 'facility': 'Università Politecnica delle Marche', 'geoPoint': {'lat': 43.60717, 'lon': 13.5103}}], 'centralContacts': [{'name': 'Armando Gabrielli, M.D.', 'role': 'CONTACT', 'email': 'a.gabrielli@staff.univpm.it', 'phone': '+390712206104'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'UNDECIDED'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Università Politecnica delle Marche', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Full Professor', 'investigatorFullName': 'Armando Gabrielli', 'investigatorAffiliation': 'Università Politecnica delle Marche'}}}}