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Clinical Trial 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.


Clinical Trial Description

PRIMARY OBJECTIVE: I. Determine the change in patient-reported rating of Cancer Connected Access and Remote Expertise (CARE) after 8 weeks in clinic compared to the same rating after 8 weeks at home. SECONDARY OBJECTIVES: I. Evaluate patient preference for location of cancer treatment administration, in the clinic or in the home. II. Longitudinally assess patient-reported function and global health/quality of life. III. Longitudinally assess patient-reported symptoms. IV. Assess the safety of cancer directed therapy when administered at home by a home health provider with remote patient monitoring and command center support. V. Describe emergency room visits and hospitalizations over the course of the study. VI. Describe overall survival (data collected out to 1 year). TERTIARY OBJECTIVE: I. Assess the cost outcomes related to patient treatment in the clinic or in the home. OUTLINE: 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 home health nursing provider (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, undergo remote patient monitoring including vital sign measurements and condition-specific symptom assessments throughout study. After completion of study treatment, patients are followed up at days 30 and 100, then every 3 months for up to 1 year. ;


Study Design


Related Conditions & MeSH terms

  • Advanced Renal Cell Carcinoma
  • Carcinoma
  • Carcinoma, Non-Small-Cell Lung
  • Carcinoma, Renal Cell
  • Carcinoma, Squamous Cell
  • Carcinoma, Transitional Cell
  • 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
  • Colorectal Neoplasms
  • Esophageal Carcinoma
  • Esophageal Neoplasms
  • Esophageal Squamous Cell Carcinoma
  • Gastroesophageal Junction Adenocarcinoma
  • Hepatocellular Carcinoma
  • Locally Advanced Urothelial Carcinoma
  • Lung Non-Small Cell Carcinoma
  • Malignant Solid Neoplasm
  • Melanoma
  • Metastatic Colorectal Carcinoma
  • Metastatic Cutaneous Melanoma
  • Metastatic Esophageal Squamous Cell Carcinoma
  • Metastatic Head and Neck Squamous Cell Carcinoma
  • Metastatic Urothelial Carcinoma
  • Recurrence
  • Recurrent Esophageal Squamous Cell Carcinoma
  • Recurrent Head and Neck Squamous Cell Carcinoma
  • Renal Cell Carcinoma
  • Skin Neoplasms
  • Squamous Cell Carcinoma of Head and Neck
  • 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

NCT number NCT06265285
Study type Interventional
Source Mayo Clinic
Contact
Status Recruiting
Phase Phase 2
Start date March 13, 2024
Completion date December 31, 2026

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