Health Trials

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

ConditionsAdvanced Esophageal Squamous Cell CarcinomaAdvanced Renal Cell CarcinomaClinical Stage II Esophageal Squamous Cell Carcinoma AJCC v8Clinical Stage IIB Cutaneous Melanoma AJCC v8Clinical Stage IIC Cutaneous Melanoma AJCC v8Clinical Stage III Cutaneous Melanoma AJCC v8Clinical Stage III Esophageal Squamous Cell Carcinoma AJCC v8Clinical Stage IV Cutaneous Melanoma AJCC v8Clinical Stage IV Esophageal Squamous Cell Carcinoma AJCC v8Esophageal CarcinomaGastroesophageal Junction AdenocarcinomaHepatocellular CarcinomaLocally Advanced Urothelial CarcinomaLung Non-Small Cell CarcinomaMalignant Solid NeoplasmMetastatic Colorectal CarcinomaMetastatic Cutaneous MelanomaMetastatic Esophageal Squamous Cell CarcinomaMetastatic Head and Neck Squamous Cell CarcinomaMetastatic Urothelial CarcinomaRecurrent Esophageal Squamous Cell CarcinomaRecurrent Head and Neck Squamous Cell CarcinomaRenal Cell CarcinomaStage III Renal Cell Cancer AJCC v8Stage IV Colorectal Cancer AJCC v8Stage IV Cutaneous Squamous Cell Carcinoma of the Head and Neck AJCC v8Stage IV Renal Cell Cancer AJCC v8Unresectable Cutaneous MelanomaUnresectable Esophageal Squamous Cell CarcinomaUrothelial CarcinomaUnresectable Urothelial Carcinoma
Trial statusRecruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexAll
Age18+
SponsorMayo Clinic

About this trial

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.

Eligibility criteria

Qualifiers

Age ≥ 18 years

Histologically confirmed malignancies for which treatment with intravenous nivolumab is currently Food and Drug Administration (FDA) approved and who are recommended to initiate a new treatment regimen with single agent intravenous (IV) nivolumab by their treating oncologist for any of the indications outlined below and who are willing to switch to subcutaneous nivolumab. Additionally, patients who are currently receiving single-agent IV nivolumab are eligible, provided they transition to subcutaneous nivolumab on-study, with their first subcutaneous (subQ) dose administered on cycle 1, day 1 of the study.

Completely resected stage IIB/C, III or IV melanoma

Urothelial carcinoma status post radical resection and have a high risk of recurrence

Disqualifiers

Patients receiving any other investigational or standard of care agent which would be considered as a treatment for the primary neoplasm and is not part of the eligible treatment regimen

Patients requiring 24/7 assistance with activities of daily living (ADLs)

Co-morbid systemic illnesses or other severe concurrent disease which, in the judgment of the investigator, would make the patient inappropriate for entry into this study or interfere significantly with the proper assessment of safety and toxicity of the prescribed regimens

Ongoing or active infection

Trial design

Treatments tested in this trial

  • Home Health Encounter
  • Nivolumab
  • Patient Monitoring
  • Questionnaire Administration

Treatment groups

50 Participants
are divided into 1 treatment group

Locations

1
Mayo Clinic in Florida32224-9980, JacksonvilleFlorida, United States

Sponsors and collaborators

Mayo Clinic

Lead sponsor

Source ClinicalTrials.gov