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

Part of paid clinical trials in Jacksonville, Florida.

Sponsor
Mayo Clinic
Study ID
NCT06265285
Phase
PHASE2
Status
Recruiting
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Conditions

  • 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
  • Unresectable Urothelial Carcinoma
  • Urothelial Carcinoma

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Home Health Encounter — OTHER
    Receive in-home visits by a home health nurse
  • Nivolumab — BIOLOGICAL
    Given SC
  • Patient Monitoring — PROCEDURE
    Undergo remote patient monitoring
  • Questionnaire Administration — OTHER
    Ancillary studies

Study Details

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.

Key Dates

Start date
Apr 30, 2024
Status verified
Jun 2026
Primary completion
Dec 31, 2026
Completion
Dec 31, 2026

Study Design

Enrollment
50 participants (estimated)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

Arms

  • Experimental: Health services research (in-clinic and at-home nivolumab)
    Patients receive nivolumab SC on day 1 of each cycle. Cycles repeat every 28 days in clinic for 2 cycles, then at home by a HHNP for 4 cycles, followed by either in-clinic or at-home administration for up to 1 year in the absence of disease progression or unacceptable toxicity. Patients receive in-home visits by a home health nurse and undergo remote patient monitoring including vital sign measurements and condition-specific symptom assessments throughout the study.

Primary Outcome Measure

Change in patient-reported rating of Cancer CARE Cancer Connected Access and Remote Expertise (CARE) after 8 weeks [ Time Frame: At baseline and up to 24 weeks of in clinic or at home care ]

Locations (1)

FacilityCityStateZIPSite coordinators
Mayo Clinic in FloridaJacksonvilleFlorida32224-9980
Clinical Trials Referral Office
[email protected]
855-776-0015
Roxana S. Dronca, M.D. (PRINCIPAL_INVESTIGATOR)

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By specialty
OncologyGI oncologyHepatologyUrology
By research site
Mayo Clinic in Florida· Jacksonville, FL

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