Actively Recruiting
Pilot Single-Arm Trial of In-Home Versus In-Clinic Subcutaneous Nivolumab Administration Through Cancer CARE (Connected Access and Remote Expertise) Beyond Walls Program
Led by Mayo Clinic · Updated on 2025-12-04
50
Participants Needed
1
Research Sites
N/A
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are evaluating subcutaneous (SC) nivolumab treatment for cancer patients to compare its delivery in an in-home setting versus an in-clinic setting. This phase II trial aims to understand how these two settings affect cancer care and patients' quality of life. Since traditional cancer care often requires long visits to clinics or hospitals, which can be isolating and burdensome, this study explores whether in-home treatment may offer a more comfortable and convenient option for patients with various advanced cancers. Participants receive SC nivolumab on day 1 of each 28-day cycle. Initially, two cycles are administered in the clinic, followed by four cycles at home with visits from a home health nurse and remote patient monitoring. After these six cycles, patients continue treatment either at home or in the clinic for up to one year, provided there is no disease progression or unacceptable side effects. The study includes ongoing monitoring through vital signs and symptom assessments to support patient safety and care. During the study, participants complete questionnaires and patient-reported assessments on their symptoms, function, comfort with treatment location, and overall quality of life. Researchers also track emergency room visits, hospitalizations, adverse events, and survival for up to one year after treatment. Follow-up visits occur at days 30 and 100 post-treatment, then every three months up to a year, to monitor long-term outcomes and safety.
CONDITIONS
Brief 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 malignancy approved for intravenous nivolumab treatment
- Recommended to start or currently receiving intravenous nivolumab and willing to switch to subcutaneous nivolumab
- Specific cancer types including melanoma, urothelial carcinoma, esophageal carcinoma, renal cell carcinoma, non-small cell lung cancer, colorectal cancer, head and neck squamous cell carcinoma, and hepatocellular carcinoma as outlined
- Recovery from prior cancer treatments with no significant residual toxicity beyond specified mild levels
- ECOG performance status of 0 or 1
- Liver and kidney function within specified laboratory limits
- Residing within 35 miles of clinic or within supplier service area
- Residence has Wi-Fi access
- Signed informed consent and able to comply with study protocol
- Willing and able to complete study questionnaires
- Women of childbearing potential must have a negative pregnancy test and agree to use effective contraception during and after treatment
You will not qualify if you...
- Receiving other investigational or non-eligible standard cancer treatments
- Requiring 24/7 assistance with daily activities
- Severe concurrent illnesses or conditions interfering with study assessments
- Uncontrolled infections or heart conditions
- Recent severe infections within 4 weeks prior to registration
- Active autoimmune diseases requiring systemic treatment (with some exceptions)
- Recent use of systemic corticosteroids or immunosuppressants beyond allowed limits
- Concurrent malignancies requiring treatment or recent history within 2 years
- Prior organ or stem cell transplant
- Active brain metastases except under strict controlled conditions
- Anticipation of major surgery during study
- Pregnant or breastfeeding
- Recent live attenuated vaccines within 30 days
- HIV with recent opportunistic infections or low CD4 count unless stable on therapy
- Allergy or hypersensitivity to study drug components
- Active hepatitis B or C infection
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - Up to 1 year
Participants receive subcutaneous nivolumab treatment initially in the clinic for 2 cycles, then at home with a home health nurse for 4 cycles, followed by continued administration either in-clinic or at home for up to 1 year if there is no disease progression or unacceptable toxicity. Participants undergo remote patient monitoring including vital sign measurements and symptom assessments throughout treatment.
1 visit every 28 days for nivolumab administration; in-home visits by a home health nurse during home treatment; remote monitoring throughout
Duration - Up to 1 year post-treatment
After completing treatment, participants are followed up to monitor overall survival and health status with visits at days 30 and 100, then every 3 months for up to 1 year.
Visits at days 30 and 100 post-treatment, then every 3 months
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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