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

NCT06265285 · Status: RECRUITING · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 50

Last updated 2025-12-04

No results posted yet for this 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.

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
  • Urothelial Carcinoma
  • Unresectable Urothelial Carcinoma

Interventions

OTHER

Home Health Encounter

Receive in-home visits by a home health nurse

BIOLOGICAL

Nivolumab

Given SC

PROCEDURE

Patient Monitoring

Undergo remote patient monitoring

OTHER

Questionnaire Administration

Ancillary studies

Sponsors & Collaborators

Principal Investigators

  • Roxana S. Dronca, M.D. · Mayo Clinic

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2024-04-30
Primary Completion
2026-12-31
Completion
2026-12-31
FDA Drug
Yes

Countries

  • United States

Study Locations

More Related Trials

Entities

Drugs
Diseases
Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06265285 on ClinicalTrials.gov