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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

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

This trial does not accept healthy volunteers

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

Design model

Single group

Treatments tested in this trial

  • Home Health Encounter

    Other intervention

    Receive in-home visits by a home health nurse

  • Nivolumab

    Biological/Vaccine

    Given SC

  • Patient Monitoring

    Procedure/Surgery

    Undergo remote patient monitoring

  • Questionnaire Administration

    Other intervention

    Ancillary studies

Treatment groups

50 Participants
are divided into 1 treatment group
Group A: Health services research (in-clinic and at-home nivolumab)Experimental treatment 4 interventions

Trial outcomes

Primary outcomes

1

Change in patient-reported rating of Cancer CARE Cancer Connected Access and Remote Expertise (CARE) after 8 weeks

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.

Time frame
At baseline and up to 24 weeks of in clinic or at home care

Secondary outcomes

1

Patient preferred treatment location

The proportion of patients who prefer care at home or express no preference will be computed and compared with the proportion of patients who prefer care in the clinic.

Time frame
Up to 24 weeks
2

Patient level of comfort with receiving injections at home

The proportion of patients who express comfort will be tabulated and a proportion greater than 70% will signify acceptance. Likert patient feedback questions and "Was It Worth It" questions will be described using frequencies and relative frequencies by arm. Numeric analog scale questions will be described using means and standard deviations and compared within patients (if applicable) using paired t-tests. Descriptive estimates at 24 weeks (after 8 weeks of in clinic and 16 weeks of at home care) will be generated throughout.

Time frame
Up to 24 weeks
3

Patient-reported symptoms - PRO-CTCAE

Patient-reported symptoms will be measured using the Patient Reported Outcomes Common Terminology Criteria for Adverse Events (PRO-CTCAE). In this study, PRO-CTCAE items were chosen based on common symptoms experienced across cancer patients and side effects common with nivolumab. A free-text item will also be included for patients to report other symptoms as willing. Adverse events (AEs) will be tabulated during the 8 weeks in clinic, and during the 8 weeks at home, compared between arms and summarized over the 24 weeks.

Time frame
Up to 24 weeks
4

Patient-reported function - EORTC QLQ-F17

Assessed using the European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire-Function 17 (EORTC QLQ-F17), a 17-item patient-reported questionnaire about patient ability to function, overall health and quality of life, and perceived financial impact of cancer and its treatment. The first 15 questions are answered on a scale of 1-4 where 1=not at all, 2=a little, 3=quite a bit, and 4=very much. The final two questions (overall health and overall quality of life during the past week) are answered on a 1-7 numeric analogue scale where 1=very poor and 7=excellent.

Time frame
Baseline; 8 weeks; 16 weeks; 24 weeks

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Mayo Clinic

Lead sponsor

Source ClinicalTrials.gov
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