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NCT06265285 · ClinicalTrials.gov registry record · Phase 2
Comparison of In-Home Versus In-Clinic Administration of Subcutaneous Nivolumab Through Cancer CARE (Connected Access and Remote Expertise) Beyond Walls (CCBW) Program
A Phase 2 study of Clinical Stage IV Cutaneous Melanoma AJCC v8 and Clinical Stage III Cutaneous Melanoma AJCC v8, sponsored by Mayo Clinic.
- Recruiting
- Registry status
- Phase 2
- Development phase
- 50
- Enrollment target
- 1
- Study location
NCT06265285: Recruiting Phase 2 study of Clinical Stage IV Cutaneous Melanoma AJCC v8 and Clinical Stage III Cutaneous Melanoma AJCC v8, sponsored by Mayo Clinic.
NCT06265285 is a Phase 2 study of Clinical Stage IV Cutaneous Melanoma AJCC v8 and Clinical Stage III Cutaneous Melanoma AJCC v8 that is actively recruiting participants, run by Mayo Clinic. The registered enrollment target is 50 participants, below the 150-participant average among 32 other Clinical Stage IV Cutaneous Melanoma AJCC v8 trials with a reported enrollment target (67% lower). The trial reports 1 study location across 1 state. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT06265285, a Phase 2 study of Clinical Stage IV Cutaneous Melanoma AJCC v8 and Clinical Stage III Cutaneous Melanoma AJCC v8, is actively recruiting participants, sponsored by Mayo Clinic.
- RECRUITING
- Registry status
- Phase 2
- Development phase
- 50 participants
- Enrollment target
- 1
- Study location
Study 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.
Primary Outcome
Measured using the Consumer Assessment of Healthcare Providers and Systems (CAHPS) Cancer Care Survey assessing "your overall cancer care experience," answered on a scale of 0-10 where 0 is the worst experience possible and 10 is the best experience possible. The change in patient-reported rating of Cancer CARE after 8 weeks of in clinic care to the same rating after 8 weeks of at home care will be compared.
Conditions Studied
Interventions
- OTHER Questionnaire Administration
- BIOLOGICAL Nivolumab
- OTHER Home Health Encounter
- PROCEDURE Patient Monitoring
Study Locations (1)
Florida
- Mayo Clinic in Florida - Jacksonville
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 50 participants |
| Start Date | 2024-04-30 |
| Est. Completion | 2026-12-31 |
| Phase | Phase 2 |
What NCT06265285 shows while recruiting
NCT06265285 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 50 participants, a relatively small participant target, below the 150-participant average among 32 other Clinical Stage IV Cutaneous Melanoma AJCC v8 trials with a reported enrollment target (67% lower).
The record links to 10 conditions, with Clinical Stage IV Cutaneous Melanoma AJCC v8 appearing as the primary indexed condition, and to 4 interventions - of which Questionnaire Administration is the first listed.
NCT06265285 reports a single indexed study location in Florida.
Frequently Asked Questions
What is clinical trial NCT06265285 about?
NCT06265285 is a clinical study titled "Comparison of In-Home Versus In-Clinic Administration of Subcutaneous Nivolumab Through Cancer CARE (Connected Access and Remote Expertise) Beyond Walls (CCBW) Program". 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...
What is the current status of trial NCT06265285?
This trial is currently recruiting. It is a Phase 2 study. The enrollment target is 50 participants. The study started on 2024-04-30. Estimated completion is 2026-12-31.
What conditions does trial NCT06265285 study?
This clinical trial studies the following conditions: Clinical Stage IV Cutaneous Melanoma AJCC v8, Clinical Stage III Cutaneous Melanoma AJCC v8, Esophageal Carcinoma, Advanced Renal Cell Carcinoma, Clinical Stage II Esophageal Squamous Cell Carcinoma AJCC v8.
What interventions are being tested in trial NCT06265285?
The interventions under investigation include: Questionnaire Administration (OTHER), Nivolumab (BIOLOGICAL), Home Health Encounter (OTHER), Patient Monitoring (PROCEDURE).
Who is sponsoring clinical trial NCT06265285?
This trial is sponsored by Mayo Clinic, which has 2,844 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT06265285 being conducted?
This trial has 1 study location across Florida. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
Similar trials for Clinical Stage IV Cutaneous Melanoma AJCC v8
Matched on the same primary condition, ranked to surface studies in the same phase first, then by recruiting status, no relevance scoring or editorial curation.
Where NCT06265285's enrollment target sits among peer trials
50 19th of 32 higher than 13 of 32 other Clinical Stage IV Cutaneous Melanoma AJCC v8 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Clinical Stage IV Cutaneous Melanoma AJCC v8 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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