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

StatusRecruiting
PhasePhase 2
Started

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Trial flagged as At Risk
Primary completion moved at least 4 months later Dec 31, 2026 → May 1, 2027
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Record History

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  1. Minor Primary and study completion pushed from Dec 31, 2026 to May 1, 2027
    • Eligibility criteria expanded, about 71 words
    • Secondary endpoints: details revised at 7 of 8 entries
  2. Minor Re-verified, no change to tracked fieldsv8
  3. Minor Eligibility criteria expanded, about 33 wordsv7
  4. Minor Eligibility criteria expanded, about 74 words
    • Study description expanded, about 1 word
    v6
  5. Minor Site contact updatedv5
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  1. Notable Start date: Mar 13, 2024 to Apr 30, 2024
    • Site contact updated
    v4
  2. Notable Trial status: Not Yet Recruiting to Recruiting
    • Start date changed from estimate of Mar 15, 2024 to Mar 13, 2024
    • Site details revised
    v3
  3. Minor Start date: Feb 15, 2024 to Mar 15, 2024v2
  1. Minor Study First Submitted
  • Notable: the trial’s plan changed such as a big move in its timeline or size, a new primary endpoint, sponsor or phase, or recruiting opened or resumed.
  • Minor: routine progress and housekeeping, such as sites added or enrollment closed.
1,024 trials monitored
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3,405 trials monitored
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and 6 more diseases
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.
Trial Details
NCT Number NCT06265285
Lead Sponsor Mayo Clinic
Conditions
(from sponsor)
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 +23 more
Related terms Carcinoma, Hepatocellular, Carcinoma, Non-Small-Cell Lung, Carcinoma, Renal Cell, Carcinoma, Transitional Cell, Colorectal Neoplasms, Esophageal Neoplasms, Esophageal Squamous Cell Carcinoma, Melanoma, Squamous Cell Carcinoma of Head and Neck
Enrollment 50 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov