Actively Recruiting
Comparison of In-Home Versus In-Clinic Administration of Subcutaneous Nivolumab Through Cancer CARE (Connected Access and Remote Expertise) Beyond Walls (CCBW) Program
Led by Mayo Clinic · Updated on 2025-12-04
50
Participants Needed
1
Research Sites
139 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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
Official Title
Comparison of In-Home Versus In-Clinic Administration of Subcutaneous Nivolumab Through Cancer CARE (Connected Access and Remote Expertise) Beyond Walls (CCBW) Program
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Age 18 years or older
- Histologically confirmed cancers approved for intravenous nivolumab treatment, recommended for new single-agent intravenous nivolumab therapy, and willing to switch to subcutaneous nivolumab
- Patients currently receiving single-agent intravenous nivolumab who agree to transition to subcutaneous nivolumab starting cycle 1, day 1
- Specific indications include adjuvant nivolumab for resected stage IIB/C, III, or IV melanoma; urothelial carcinoma post radical resection at high recurrence risk; resected esophageal or gastroesophageal junction carcinoma with residual disease after neoadjuvant chemoradiotherapy
- Advanced/metastatic cancers including renal cell carcinoma after anti-angiogenic therapy, non-small cell lung cancer post platinum chemotherapy, unresectable esophageal squamous cell carcinoma after prior chemotherapy, unresectable/metastatic cutaneous melanoma, locally advanced/metastatic urothelial carcinoma after platinum chemotherapy or as first-line with cisplatin and gemcitabine
- Patients transitioning to maintenance nivolumab after combination therapy for specific indications
- Adjuvant nivolumab after neoadjuvant platinum doublet chemotherapy for resectable NSCLC without EGFR or ALK mutations
- Recovery from previous treatments with no worse than grade 1 residual toxicity
- ECOG performance status 0 or 1
- Liver and blood lab values within specified limits
- Residing within 35 miles of clinic or service area
- Home Wi-Fi to support remote monitoring
- Signed informed consent
- Willing and able to follow study protocol and complete questionnaires
- Women of childbearing potential must have negative pregnancy test and agree to highly effective contraception during and 5 months after treatment
You will not qualify if you...
- Receiving other investigational or standard care agents outside the eligible regimen
- Requiring 24/7 assistance with daily living activities
- Severe concurrent diseases or illnesses that may interfere with safety assessment
- Uncontrolled illnesses such as active infection, symptomatic heart failure, unstable angina, arrhythmia, recent myocardial infarction, wound healing disorders, or psychiatric/social situations limiting compliance
- Severe infection within 4 weeks prior to registration
- Active autoimmune disease except certain controlled conditions
- Systemic corticosteroid or immunosuppressive treatment within specified time frames
- Concurrent malignancy requiring treatment or active within 2 years prior
- Prior organ or stem cell transplant
- Active brain or leptomeningeal metastases with exceptions
- Planned major surgery during study
- Pregnant or breastfeeding
- Live attenuated vaccine within 30 days of registration
- HIV positive with recent opportunistic infection or low CD4 count unless stable on therapy
- Allergy or hypersensitivity to study drug components
- Active hepatitis B or C infection except controlled HCV without detectable virus
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 1 location
1
Mayo Clinic in Florida
Jacksonville, Florida, United States, 32224-9980
Actively Recruiting
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
TREATMENT
Number of Arms
1
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