protocolSection identificationModule nctId: NCT06345183, orgStudyIdInfo id: CA209-1275, briefTitle: Real-World Outcomes of Nivolumab+Ipilimumab and Pembrolizumab+Lenvatinib Among US Advanced Renal Cell Carcinoma (aRCC) Patients, statusModule overallStatus: RECRUITING, startDateStruct date: 2024-02-19, primaryCompletionDateStruct date: 2024-04-01, completionDateStruct date: 2024-12-31, studyFirstPostDateStruct date: 2024-04-03, lastUpdatePostDateStruct date: 2024-04-03, sponsorCollaboratorsModule leadSponsor name: Bristol-Myers Squibb, class: INDUSTRY, descriptionModule briefSummary: This observational study aims to describe demographic, clinical characteristics, treatment patterns outcomes of participants with advanced Renal Cell Carcinoma (aRCC) receiving either Nivolumab + Ipilimumab, or Pembrolizumab + Lenvatinib combination therapy, conditionsModule conditions: Advanced Renal Cell Carcinoma (aRCC), designModule studyType: OBSERVATIONAL, designInfo observationalModel: COHORT, timePerspective: OTHER, enrollmentInfo count: 350, type: ESTIMATED, armsInterventionsModule interventions name: Nivolumab + Ipilimumab combination therapy, interventions name: Pembrolizumab + Lenvatinib combination therapy, outcomesModule primaryOutcomes measure: Participant year of birth, primaryOutcomes measure: Participant sex at birth, primaryOutcomes measure: Participant primary payer, primaryOutcomes measure: Participant race, primaryOutcomes measure: Participant ethnicity, primaryOutcomes measure: Participant U.S. state of residence, primaryOutcomes measure: Participant initial Renal Cell Carcinoma (RCC) diagnoses, primaryOutcomes measure: American Joint Committee on Cancer (AJCC) TNM stage, primaryOutcomes measure: Participant advanced/metastatic Renal Cell Carcinoma (RCC) diagnosis, primaryOutcomes measure: Participant renal cell carcinoma (RCC) histology results, primaryOutcomes measure: Participant tumor grade, primaryOutcomes measure: Participant biomarker or genetic testing method, primaryOutcomes measure: Participant molecular and/or genetic mutations reported, primaryOutcomes measure: Participant site of metastatic disease, primaryOutcomes measure: Participant Eastern Cooperative Oncology Group (ECOG) Performance Status (PS), primaryOutcomes measure: Participant Karnofsky score (KPS), primaryOutcomes measure: Participant comorbidities and/or chronic conditions, primaryOutcomes measure: Participant blood test results, primaryOutcomes measure: Participant Memorial Sloan Kettering Cancer Center (MSKCC) score, primaryOutcomes measure: Participant International Metastatic Renal-Cell Carcinoma Database Consortium (IMDC) score, primaryOutcomes measure: Participant smoking status, primaryOutcomes measure: Participant COVID-19 status, primaryOutcomes measure: Participant surgical history, primaryOutcomes measure: Participant radiation treatment history, primaryOutcomes measure: Participant treatment regimen received, primaryOutcomes measure: Participant treatment initiation and discontinuation dates, primaryOutcomes measure: Participant rationale for discontinuation of treatment, primaryOutcomes measure: Participant radiation therapy prescribed, primaryOutcomes measure: Participant total number of radiotherapy cycles, primaryOutcomes measure: Participant initial dose and frequency/schedule of index therapy, primaryOutcomes measure: Participant index treatment dose modifications, primaryOutcomes measure: Participant rationale for dose modifications of index therapy, primaryOutcomes measure: Participant date of dose modifications of index therapy, primaryOutcomes measure: Participant last dose and frequency/schedule of index therapy, eligibilityModule sex: ALL, minimumAge: 18 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: Cardinal Health, status: RECRUITING, city: Dublin, state: Ohio, zip: 43017, country: United States, geoPoint lat: 40.09923, lon: -83.11408, hasResults: False