nctId: NCT06265285 id: MC230716 id: NCI-2024-00637 type: REGISTRY domain: CTRP (Clinical Trial Reporting Program) id: 23-009663 type: OTHER domain: Mayo Clinic Institutional Review Board 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 overallStatus: RECRUITING date: 2024-03-13 date: 2026-12-31 date: 2026-12-31 date: 2024-02-20 date: 2024-03-15 name: Mayo Clinic class: OTHER 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. 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 studyType: INTERVENTIONAL phases: PHASE2 allocation: NA interventionModel: SINGLE_GROUP primaryPurpose: HEALTH_SERVICES_RESEARCH masking: NONE count: 50 type: ESTIMATED name: Home Health Encounter name: Nivolumab name: Patient Monitoring name: Questionnaire Administration measure: Change in patient-reported rating of Cancer CARE Cancer Connected Access and Remote Expertise (CARE) after 8 weeks measure: Patient preferred treatment location measure: Patient level of comfort with receiving injections at home measure: Patient-reported symptoms - PRO-CTCAE measure: Patient-reported function - EORTC QLQ-F17 measure: Patient-reported side effect impact - GP5 measure: Incidence of Adverse Events (AEs) measure: Emergency room visits and hospitalizations measure: Overall survival (OS) sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Mayo Clinic in Florida status: RECRUITING city: Jacksonville state: Florida zip: 32224-9980 country: United States name: Clinical Trials Referral Office role: CONTACT phone: 855-776-0015 email: mayocliniccancerstudies@mayo.edu name: Roxana S. Dronca, M.D. role: PRINCIPAL_INVESTIGATOR lat: 30.33218 lon: -81.65565 hasResults: False