protocolSection identificationModule nctId: NCT06265285, orgStudyIdInfo id: MC230716, secondaryIdInfos id: NCI-2024-00637, type: REGISTRY, domain: CTRP (Clinical Trial Reporting Program), secondaryIdInfos id: 23-009663, type: OTHER, domain: Mayo Clinic Institutional Review Board, secondaryIdInfos id: MC230716, type: OTHER, domain: Mayo Clinic in Florida, briefTitle: Comparison of In-Home Versus In-Clinic Administration of Subcutaneous Nivolumab Through Cancer CARE (Connected Access and Remote Expertise) Beyond Walls (CCBW) Program, statusModule overallStatus: RECRUITING, startDateStruct date: 2024-03-13, primaryCompletionDateStruct date: 2026-12-31, completionDateStruct date: 2026-12-31, studyFirstPostDateStruct date: 2024-02-20, lastUpdatePostDateStruct date: 2024-03-15, sponsorCollaboratorsModule leadSponsor name: Mayo Clinic, class: OTHER, descriptionModule briefSummary: This phase II trial compares the impact of subcutaneous (SC) nivolumab given in an in-home setting to an in-clinic setting on cancer care and quality of life. Currently, most drug-related cancer care is conducted in clinic type centers or hospitals which may isolate patients from family, friends and familiar surroundings for many hours per day. This separation adds to the physical, emotional, social, and financial burden for patients and their families. Traveling to and from medical facilities costs time, money, and effort and can be a disadvantage to patients living in rural areas, those with low incomes or poor access to transport. Studies have shown that cancer patients often feel more comfortable and secure being cared for in their own home environments. SC nivolumab in-home treatment may be safe, tolerable and/or effective when compared to in-clinic treatment and may reduce the burden of cancer and improve the quality of life in cancer patients., conditionsModule conditions: Advanced Esophageal Squamous Cell Carcinoma, conditions: Advanced Renal Cell Carcinoma, conditions: Clinical Stage II Esophageal Squamous Cell Carcinoma AJCC v8, conditions: Clinical Stage IIB Cutaneous Melanoma AJCC v8, conditions: Clinical Stage IIC Cutaneous Melanoma AJCC v8, conditions: Clinical Stage III Cutaneous Melanoma AJCC v8, conditions: Clinical Stage III Esophageal Squamous Cell Carcinoma AJCC v8, conditions: Clinical Stage IV Cutaneous Melanoma AJCC v8, conditions: Clinical Stage IV Esophageal Squamous Cell Carcinoma AJCC v8, conditions: Esophageal Carcinoma, conditions: Gastroesophageal Junction Adenocarcinoma, conditions: Hepatocellular Carcinoma, conditions: Locally Advanced Urothelial Carcinoma, conditions: Lung Non-Small Cell Carcinoma, conditions: Malignant Solid Neoplasm, conditions: Metastatic Colorectal Carcinoma, conditions: Metastatic Cutaneous Melanoma, conditions: Metastatic Esophageal Squamous Cell Carcinoma, conditions: Metastatic Head and Neck Squamous Cell Carcinoma, conditions: Metastatic Urothelial Carcinoma, conditions: Recurrent Esophageal Squamous Cell Carcinoma, conditions: Recurrent Head and Neck Squamous Cell Carcinoma, conditions: Renal Cell Carcinoma, conditions: Stage III Renal Cell Cancer AJCC v8, conditions: Stage IV Colorectal Cancer AJCC v8, conditions: Stage IV Cutaneous Squamous Cell Carcinoma of the Head and Neck AJCC v8, conditions: Stage IV Renal Cell Cancer AJCC v8, conditions: Unresectable Cutaneous Melanoma, conditions: Unresectable Esophageal Squamous Cell Carcinoma, conditions: Urothelial Carcinoma, designModule studyType: INTERVENTIONAL, phases: PHASE2, designInfo allocation: NA, interventionModel: SINGLE_GROUP, primaryPurpose: HEALTH_SERVICES_RESEARCH, maskingInfo masking: NONE, enrollmentInfo count: 50, type: ESTIMATED, armsInterventionsModule interventions name: Home Health Encounter, interventions name: Nivolumab, interventions name: Patient Monitoring, interventions name: Questionnaire Administration, outcomesModule primaryOutcomes measure: Change in patient-reported rating of Cancer CARE Cancer Connected Access and Remote Expertise (CARE) after 8 weeks, secondaryOutcomes measure: Patient preferred treatment location, secondaryOutcomes measure: Patient level of comfort with receiving injections at home, secondaryOutcomes measure: Patient-reported symptoms - PRO-CTCAE, secondaryOutcomes measure: Patient-reported function - EORTC QLQ-F17, secondaryOutcomes measure: Patient-reported side effect impact - GP5, secondaryOutcomes measure: Incidence of Adverse Events (AEs), secondaryOutcomes measure: Emergency room visits and hospitalizations, secondaryOutcomes measure: Overall survival (OS), eligibilityModule sex: ALL, minimumAge: 18 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: Mayo Clinic in Florida, status: RECRUITING, city: Jacksonville, state: Florida, zip: 32224-9980, country: United States, contacts name: Clinical Trials Referral Office, role: CONTACT, phone: 855-776-0015, email: mayocliniccancerstudies@mayo.edu, contacts name: Roxana S. Dronca, M.D., role: PRINCIPAL_INVESTIGATOR, geoPoint lat: 30.33218, lon: -81.65565, hasResults: False