Ignite Creation Date:
2025-12-25 @ 3:37 AM
Ignite Modification Date:
2026-03-03 @ 9:38 AM
Study NCT ID:
NCT04540705
Status:
COMPLETED
Last Update Posted:
2024-02-28
First Post:
2020-09-03
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
A Study to Compare Bempegaldesleukin (BEMPEG: NKTR-214) Combined With Nivolumab and Tyrosine Kinase Inhibitor (TKI) to Nivolumab and TKI Alone in Participants With Previously Untreated Kidney Cancer That is Advanced or Has Spread
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24', 'removedCountries': ['Spain']}, 'conditionBrowseModule': {'meshes': [{'id': 'D002292', 'term': 'Carcinoma, Renal Cell'}], 'ancestors': [{'id': 'D000230', 'term': 'Adenocarcinoma'}, {'id': 'D002277', 'term': 'Carcinoma'}, {'id': 'D009375', 'term': 'Neoplasms, Glandular and Epithelial'}, {'id': 'D009370', 'term': 'Neoplasms by Histologic Type'}, {'id': 'D009369', 'term': 'Neoplasms'}, {'id': 'D007680', 'term': 'Kidney Neoplasms'}, {'id': 'D014571', 'term': 'Urologic Neoplasms'}, {'id': 'D014565', 'term': 'Urogenital Neoplasms'}, {'id': 'D009371', 'term': 'Neoplasms by Site'}, {'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'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D000077594', 'term': 'Nivolumab'}, {'id': 'D000077784', 'term': 'Axitinib'}, {'id': 'C558660', 'term': 'cabozantinib'}], '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'}, {'id': 'D001549', 'term': 'Benzamides'}, {'id': 'D000577', 'term': 'Amides'}, {'id': 'D009930', 'term': 'Organic Chemicals'}, {'id': 'D001565', 'term': 'Benzoates'}, {'id': 'D000146', 'term': 'Acids, Carbocyclic'}, {'id': 'D002264', 'term': 'Carboxylic Acids'}, {'id': 'D001555', 'term': 'Benzene Derivatives'}, {'id': 'D006841', 'term': 'Hydrocarbons, Aromatic'}, {'id': 'D006844', 'term': 'Hydrocarbons, Cyclic'}, {'id': 'D006838', 'term': 'Hydrocarbons'}, {'id': 'D007191', 'term': 'Indazoles'}, {'id': 'D011720', 'term': 'Pyrazoles'}, {'id': 'D001393', 'term': 'Azoles'}, {'id': 'D006573', 'term': 'Heterocyclic Compounds, 1-Ring'}, {'id': 'D006571', 'term': 'Heterocyclic Compounds'}, {'id': 'D006574', 'term': 'Heterocyclic Compounds, 2-Ring'}, {'id': 'D000072471', 'term': 'Heterocyclic Compounds, Fused-Ring'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE1'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NON_RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 30}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2020-09-11', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-02', 'completionDateStruct': {'date': '2024-01-18', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2024-02-26', 'studyFirstSubmitDate': '2020-09-03', 'studyFirstSubmitQcDate': '2020-09-03', 'lastUpdatePostDateStruct': {'date': '2024-02-28', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2020-09-07', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2024-01-18', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Incidence of adverse events (AEs) by severity (Part 1)', 'timeFrame': 'Up to 2.5 years'}, {'measure': 'Incidence of serious adverse events (SAEs) (Part 1)', 'timeFrame': 'Up to 2.5 years'}, {'measure': 'Incidence of dose-limiting toxicities (DLTs) (Part 1)', 'timeFrame': 'Up to 2.5 years'}, {'measure': 'Incidence of AEs leading to discontinuation (Part 1)', 'timeFrame': 'Up to 5 years'}, {'measure': 'Incidence of immune-mediated adverse events (imAEs) (Part 1)', 'timeFrame': 'Up to 5 years'}, {'measure': 'Incidence of changes in clinical laboratory results by severity: Hematology tests (Part 1)', 'timeFrame': 'Up to 2.5 years'}, {'measure': 'Incidence of changes in clinical laboratory results by severity: Clinical Chemistry tests (Part 1)', 'timeFrame': 'Up to 2.5 years'}, {'measure': 'Incidence of changes in clinical laboratory results by severity: Urinalysis tests (Part 1)', 'timeFrame': 'Up to 2.5 years'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': True, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['NKTR-214', 'nivolumab', 'bempeg'], 'conditions': ['Renal Cell Carcinoma']}, 'referencesModule': {'seeAlsoLinks': [{'url': 'https://www.bms.com/researchers-and-partners/clinical-trials-and-research.html', 'label': 'BMS Clinical Trial Information'}, {'url': 'https://www.bmsstudyconnect.com/content/studyconnect/us/en/clinical-trials/NCT04540705.html', 'label': 'BMS Clinical Trial Patient Recruiting'}]}, 'descriptionModule': {'briefSummary': 'The purpose of this study is in Part 1, to determine the safety of nivolumab, bempegaldesleukin (BEMPEG: NKTR-214), and Tyrosine Kinase Inhibitor (TKI) combination.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Histological confirmation of renal cell carcinoma (RCC) with clear cell component including participants who may also have sarcomatoid features\n* Advanced (not amenable to curative surgery or radiation therapy) or metastatic (American Joint Committee on Cancer (AJCC) Stage 4) RCC\n* No prior systemic therapy, including prior PD-L1 therapy, for RCC is allowed with the following exception:\n\n i) One prior adjuvant or neoadjuvant therapy for completely resectable RCC is allowed. Therapy must have included an agent that targets vascular endothelial growth factor (VEGF) pathway or VEGF receptors and recurrence must have occurred at least 6 months after the last dose of adjuvant or neoadjuvant therapy\n* Life Expectancy ≥ 12 weeks\n* Karnofsky Performance Status (KPS) of at least 70%\n* Measurable disease by computed tomography (CT) or magnetic resonance imaging (MRI) per RECIST 1.1 criteria\n* Males and females must agree to follow specific methods of contraception, if applicable\n\nExclusion Criteria:\n\n* Active CNS brain metastases or leptomeningeal metastases\n* Active, known or suspected autoimmune disease\n* Inadequately treated adrenal insufficiency\n* History of pulmonary embolism (PE), deep vein thrombosis (DVT), or prior clinically significant venous or non-CVA/TIA arterial thromboembolic event (eg, internal jugular vein thrombosis) within 3 months prior to treatment assignment (Part 1) and randomization (Part 2)\n\nOther protocol-defined inclusion/exclusion criteria apply'}, 'identificationModule': {'nctId': 'NCT04540705', 'acronym': 'PIVOT IO 011', 'briefTitle': 'A Study to Compare Bempegaldesleukin (BEMPEG: NKTR-214) Combined With Nivolumab and Tyrosine Kinase Inhibitor (TKI) to Nivolumab and TKI Alone in Participants With Previously Untreated Kidney Cancer That is Advanced or Has Spread', 'organization': {'class': 'INDUSTRY', 'fullName': 'Bristol-Myers Squibb'}, 'officialTitle': 'A Phase 1 Study to Compare Bempegaldesleukin Combined With Nivolumab and Tyrosine Kinase Inhibitor (TKI) to Nivolumab and TKI Alone in Participants With Previously Untreated Advanced or Metastatic Renal Cell Carcinoma (mRCC) (PIVOT IO 011)', 'orgStudyIdInfo': {'id': 'CA045-011'}, 'secondaryIdInfos': [{'id': '2018-003200-39', 'type': 'EUDRACT_NUMBER'}, {'id': '18-214-15', 'type': 'OTHER', 'domain': 'Nektar Therapeutics'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Part 1A (Part 1): Nivolumab + Axitinib', 'interventionNames': ['Biological: Nivolumab', 'Drug: Axitinib']}, {'type': 'EXPERIMENTAL', 'label': 'Part 1B (Part 1): Nivolumab + Cabozantinib', 'interventionNames': ['Biological: Nivolumab', 'Drug: Cabozantinib']}], 'interventions': [{'name': 'Nivolumab', 'type': 'BIOLOGICAL', 'otherNames': ['OPDIVO'], 'description': 'Specified dose on specified days', 'armGroupLabels': ['Part 1A (Part 1): Nivolumab + Axitinib', 'Part 1B (Part 1): Nivolumab + Cabozantinib']}, {'name': 'Axitinib', 'type': 'DRUG', 'otherNames': ['INLYTA'], 'description': 'Specified dose on specified days', 'armGroupLabels': ['Part 1A (Part 1): Nivolumab + Axitinib']}, {'name': 'Cabozantinib', 'type': 'DRUG', 'otherNames': ['Cabometyx'], 'description': 'Specified dose on specified days', 'armGroupLabels': ['Part 1B (Part 1): Nivolumab + Cabozantinib']}]}, 'contactsLocationsModule': {'locations': [{'zip': '72762', 'city': 'Springdale', 'state': 'Arkansas', 'country': 'United States', 'facility': 'Local Institution - 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