Phase 2 Study Comparing In-Home Versus In-Clinic Treatment with Subcutaneous Nivolumab in Adults with Various Advanced Cancers

What this Trial Is About

This phase II trial is evaluating the impact of giving subcutaneous nivolumab to cancer patients either at home or in a clinic setting. The study aims to assess how these different treatment locations affect cancer care and patients quality of life, recognizing that clinic visits can increase physical, emotional, social, and financial burdens, especially for those living far from treatment centers. Researchers want to see if home administration can reduce these burdens and improve comfort. Participants receive nivolumab injections under the skin on day 1 of each 28-day treatment cycle. Initially, patients receive two cycles in the clinic, followed by four cycles at home with visits from a home health nurse. Afterward, patients continue treatment either at home or in the clinic for up to one year if their disease does not worsen and side effects are acceptable. Throughout the study, patients undergo remote monitoring of vital signs and symptoms by a command center. During the trial, participants complete questionnaires about their health, symptoms, and treatment experience. Researchers track emergency room visits, hospitalizations, and overall survival for up to one year after treatment ends. Follow-up visits occur 30 and 100 days after treatment completion, then every three months for up to a year. The study measures changes in patient-reported cancer care ratings and preferences, symptom impact, and safety of home-based treatment.

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