Comparison of In-Home Versus In-Clinic Administration of Subcutaneous Nivolumab Through Cancer CARE (Connected Access and Remote Expertise) Beyond Walls (CCBW) Program

Recruiting Phase 2 Interventional Study
Advanced Esophageal Squamous Cell Carcinoma Advanced Renal Cell Carcinoma Clinical Stage II Esophageal Squamous Cell Carcinoma AJCC v8 Clinical Stage IIB Cutaneous Melanoma AJCC v8 Clinical Stage IIC Cutaneous Melanoma AJCC v8 Clinical Stage III Cutaneous Melanoma AJCC v8 Clinical Stage III Esophageal Squamous Cell Carcinoma AJCC v8 Clinical Stage IV Cutaneous Melanoma AJCC v8 Clinical Stage IV Esophageal Squamous Cell Carcinoma AJCC v8 Esophageal Carcinoma Gastroesophageal Junction Adenocarcinoma Hepatocellular Carcinoma Locally Advanced Urothelial Carcinoma Lung Non-Small Cell Carcinoma Malignant Solid Neoplasm Metastatic Colorectal Carcinoma Metastatic Cutaneous Melanoma Metastatic Esophageal Squamous Cell Carcinoma Metastatic Head and Neck Squamous Cell Carcinoma Metastatic Urothelial Carcinoma Recurrent Esophageal Squamous Cell Carcinoma Recurrent Head and Neck Squamous Cell Carcinoma Renal Cell Carcinoma Stage III Renal Cell Cancer AJCC v8 Stage IV Colorectal Cancer AJCC v8 Stage IV Cutaneous Squamous Cell Carcinoma of the Head and Neck AJCC v8 Stage IV Renal Cell Cancer AJCC v8 Unresectable Cutaneous Melanoma Unresectable Esophageal Squamous Cell Carcinoma Urothelial Carcinoma Unresectable Urothelial Carcinoma
No Placebo Group Every participant receives an active treatment — no one gets a placebo. Prior Safety Data This treatment has already been tested in at least one earlier human trial.
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At a Glance
Age
18 and older
Sex
Any
Trial phase
Phase 2
Study type
Interventional
Purpose
Treatment
Participants needed
50 (estimated)
Sponsor
Mayo Clinic · Other
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About This Trial
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, soci…
Trial Locations
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Eligibility Criteria
Inclusion Criteria: * Age ≥ 18 years * Histologically confirmed malignancies for which treatment with intravenous nivolumab is currently Food and Drug Administration (FDA) approved and who are recommended to initiate a new treatment regimen with single agent intravenous (IV) nivolumab by their trea…
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