RecruitingPhase 2NCT06265285

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

Pilot Single-Arm, Pragmatic Trial of In-Home Versus In-Clinic Subcutaneous Nivolumab Administration Through Cancer CARE (Connected Access and Remote Expertise) Beyond Walls (CCBW) Program


Sponsor

Mayo Clinic

Enrollment

50 participants

Start Date

Apr 30, 2024

Study Type

INTERVENTIONAL

Conditions

Summary

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.


Eligibility

Min Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This study is comparing giving nivolumab (an immunotherapy cancer drug) at home under-the-skin (subcutaneous) versus in a clinic through an IV drip, to see whether home administration is just as safe and convenient for patients with various cancers. **You may be eligible if...** - You are 18 or older - You have a cancer for which nivolumab is FDA-approved as a single-agent treatment - Your oncologist recommends nivolumab for you - You are willing to switch from IV nivolumab to the under-the-skin version for this study **You may NOT be eligible if...** - You are receiving nivolumab as part of a combination regimen (not single agent) - You have active autoimmune disease requiring systemic treatment - You have certain serious infections or organ function problems Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

OTHERHome Health Encounter

Receive in-home visits by a home health nurse

BIOLOGICALNivolumab

Given SC

PROCEDUREPatient Monitoring

Undergo remote patient monitoring

OTHERQuestionnaire Administration

Ancillary studies


Locations(1)

Mayo Clinic in Florida

Jacksonville, Florida, United States

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NCT06265285


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