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Nivolumab

Antineoplastic Agents, Immunological

Immune Checkpoint Inhibitors

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 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 and undergo remote patient monitoring including vital sign measurements and condition-specific symptom assessments throughout study.

Receive in-home visits by a home health nurse

Home Health Encounter

Patient Monitoring

Questionnaire Administration

Clinical Trials Referral Office

Roxana S. Dronca, M.D.

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 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.

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

Pilot Single-Arm, Pragmatic Trial of In-Home Versus In-Clinic Subcutaneous Nivolumab Administration Through Cancer CARE (Connected Access and Remote Expertise) Beyond Walls (CCBW) Program

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.

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.

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.

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.

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.

Assessed using the Functional Assessment of Chronic Illness Therapy (FACIT) - Item GP5, "I am bothered by side effects of treatment," which is answered on a scale ranging from 0 (Not at all) to 4 (Very Much). Responses will be computed and compared across patients visits. Mean GP5 scores over time will also be explored.

The maximum grade for each type of AE will be summarized using Common Terminology Criteria for Adverse Events version 5.0. The frequency and percentage of grade 3+ AEs will be reported and compared using McNemar's test.

The proportion of patients with an emergency room visit or hospitalization will be computed and compared using McNemar's test. Proportion of patients with emergency room visits or hospitalizations will also be summarized over the entire study.

OS is defined as the time from study entry to death from any cause. OS will be estimated using the Kaplan-Meier method.

Mayo Clinic

Heart and Blood Diseases

Blood and Lymph Conditions

Immune System Diseases

Gland and Hormone Related Diseases

Multiple Myeloma

Neoplasms, Plasma Cell

Prostatic Neoplasms

Stomach Neoplasms

Breast Neoplasms

Syndrome

Pancreatic Neoplasms

Ovarian Neoplasms

Carcinoma, Ovarian Epithelial

Urinary Bladder Neoplasms

Glioblastoma

Small Cell Lung Carcinoma

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Carcinoid Tumor

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Hemorrhagic Disorders

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Immunoproliferative Disorders

Bone Marrow Diseases

Astrocytoma

Glioma

Neoplasms, Neuroepithelial

Breast Diseases

Endocrine Gland Neoplasms

Endocrine System Diseases

Pancreatic Diseases

Stomach Diseases

Urinary Bladder Diseases

Stomach Cancer

Pancreatic Cancer

Ovarian Cancer

Ovarian Epithelial Cancer

Small Cell Lung Cancer

Germ Cells Tumors

Anal Cancer

Malignant Germ Cell Tumor

Patients continue receiving their SOC chemotherapy regimen at home for approximately 24 weeks in the absence of disease progression or unacceptable toxicity. This includes drug administrations, injections/infusions and routine clinical laboratory tests in the home from the HHNP, overseen by Mayo Clinic's home health program CCBW Command Center. Patients are also provided biometric devices for health monitoring vital signs, as well as a computer tablet for video visits with the Mayo Clinic care team.

Patients continue receiving their SOC chemotherapy regimen in the clinic for approximately 8 weeks in the absence of disease progression or unacceptable toxicity. Patients then begin receiving their SOC chemotherapy regimen at home as in Arm I for an approximate additional 16 weeks in the absence of disease progression or unacceptable toxicity.

Clinical Encounter

Quality-of-Life Assessment

This clinical trial studies the effect of cancer directed therapy given at-home versus in the clinic for patients with cancer that may have spread from where it first started to nearby tissue, lymph nodes, or distant parts of the body (advanced). Currently most drug-related cancer care is conducted in infusion centers or specialty hospitals, where patients spend many hours a day isolated from family, friends, and familiar surroundings. This separation adds to the physical, emotional, social, and financial burden for patients and their families. The logistics and costs of navigating cancer treatments have become a principal contributor to patients' reduced quality of life. It is therefore important to reduce the burden of cancer in the lives of patients and their caregivers, and a vital aspect of this involves moving beyond traditional hospital and clinic-based care and evaluate innovative care delivery models with virtual capabilities. Providing cancer treatment at-home, versus in the clinic, may help reduce psychological and financial distress and increase treatment compliance, especially for marginalized patients and communities.

PRIMARY OBJECTIVE:

I. To compare mean patient-reported rating of Cancer Connected Access and Remote Expertise (CARE) using a modified question from the Consumer Assessment of Healthcare Providers and Systems (CAHPS) Cancer Care Survey after 8 weeks between patients randomized to receive care at home and care in the clinic.

SECONDARY OBJECTIVES:

I. To evaluate patient preference for location of cancer treatment administration, at the infusion center or in the home.

II. To evaluate level of comfort with receiving infusions at home based on the following measures after 24 weeks of treatment (or at end of study):

IIa. The proportion of patients who indicate a preference for home infusion or no preference versus outpatient infusion unit administration of cancer treatment as assessed via the Patient Preference Questionnaire; IIb. The proportion of patients who indicate comfort (quite a bit or very much) with receiving infusions at home as assessed by the Patient Preference Questionnaire.

III. To describe other patient experience questions within the Patient Preference Questionnaire after 24 weeks of treatment (or at end of study).

IV. To describe whether patients felt that infusions at home was worthwhile, would do it again, and recommend it to others after 24 weeks of treatment (or at end of study) using the Was It Worth It questionnaire.

V. To test whether home-based virtual delivery of cancer directed therapy is superior to standard administration (in clinic) in patient-reported function and global health/quality of life as measured by the European Organization for Research and Treatment of Cancer Quality of Life Questionnaire Core Function 17-Item (EORTC QLQ-F17) after 8 weeks of home versus outpatient infusion unit administration of cancer treatment.

VI. To test whether home-based virtual delivery of cancer directed therapy is superior to standard administration (in clinic) in patient-reported symptoms as measured by the Patient-Reported Outcomes-Common Terminology Criteria for Adverse Events (PRO-CTCAE) after 8 weeks of home versus outpatient infusion unit administration of cancer treatment.

VII. To assess the safety of cancer directed therapy when administered at home by a home health provider with remote patient monitoring and Command Center support, based on the incidence, nature, and severity of the following:

VIIa. Grade 3+ adverse event (AE) clinically graded using the National Cancer Institute Common Terminology Criteria for Adverse Events version 5.0 (NCI CTCAE v5.0).

VIII. To test whether home-based virtual delivery of cancer directed therapy is superior to standard in clinic administration in the proportion of patients with an emergency room visit or hospitalization at the end of 6 months of study treatment.

IX. Overall survival.

EXPLORATORY OBJECTIVES:

I. To assess the cost of care in first 6 months (data collected out to 1 year). II. To evaluate administration of treatment based on clinical practice data.

OUTLINE:

Patients receive the first 2 cycles of their standard of care (SOC) chemotherapy regimen in the clinic in the absence of disease progression or unacceptable toxicity. Patients are then randomized to 1 of 2 arms.

ARM A: Patients continue receiving their SOC chemotherapy regimen at home for approximately 24 weeks in the absence of disease progression or unacceptable toxicity. This includes drug administrations, injections/infusions and routine clinical laboratory tests in the home from the Home Health Nurse Provider (HHNP), overseen by Mayo Clinic's home health program Cancer CARE Beyond Walls (CCBW) Command Center. Patients are also provided biometric devices for health monitoring vital signs, as well as a computer tablet for video visits with the Mayo Clinic care team.

ARM B: Patients continue receiving their SOC chemotherapy regimen in the clinic for approximately 8 weeks in the absence of disease progression or unacceptable toxicity. Patients then begin receiving their SOC chemotherapy regimen at home as in Arm I for an approximate additional 16 weeks in the absence of disease progression or unacceptable toxicity.

After completion of study intervention, patients are followed for 1 year.

At-Home Cancer Directed Therapy Versus in Clinic for the Treatment of Patients With Advanced Cancer

Cancer CARE Beyond Walls - A Pilot of a Randomized, Pragmatic Trial of Cancer Directed Therapy Administration in the Patients' Homes Versus in Clinic

This hypothesis test will use patient ratings from a single 0-10 item from the Consumer Assessment of Healthcare Providers and Systems Cancer Care Survey assessing "your overall cancer care experience". Will be compared between arms using a two-sample t-test.

The proportion of patients who preferred care at home or expressed no preference will be computed and compared to 50% using a one-group test of proportions. Additional Likert patient feedback questions and "Was It Worth It" questions at each time point will be described using frequencies and relative frequencies by arm (or overall if applicable) and compared between arms (if applicable) using chi-squared tests. Numeric analog scale questions will be described using means and standard deviations and compared between arms (if applicable) using t-tests.

Patient responses to comfort level with receiving infusions at home will be described using frequencies and relative frequencies. The proportion of patients who express comfort (quite a bit or very much) will also be tabulated and a proportion greater than 70% will signify acceptance. Additional Likert patient feedback questions and "Was It Worth It" questions at each time point will be described using frequencies and relative frequencies by arm (or overall if applicable) and compared between arms (if applicable) using chi-squared tests. Numeric analog scale questions will be described using means and standard deviations and compared between arms (if applicable) using t-tests.

Measured by the Was it Worth It questionnaire. The Was It Worth It questionnaire asks patients whether they thought that receiving chemo/infusions at home was worthwhile, whether they would do it again, and whether they would recommend it to others.

Measured by the European Organization for Research and Treatment of Cancer. Mean and standard deviation of each scale will be computed by arm. Means and standard deviations of each scale will also be computed at all other assessment time points. Mean changes from baseline in each scale at 8 weeks (and other assessment time points) will be compared between arms using a linear combination of parameters from a general linear mixed model. Each model will include all available data from all time points. Fixed effects will include arm, time point, and arm-by-time point interaction. Repeated observations by patient will be modeled using compound symmetric correlation structure over time. Such values as the mean change from baseline at 8 weeks by arm, and difference in mean change from baseline at 8 weeks between arms will be estimated with confidence intervals based on the mixed model. Comparisons at other time points will also be carried out and graphically displayed using mean plots.

Will be measured by the Patient-Reported Outcomes-Common Terminology Criteria for Adverse Events (CTCAE) and summarized using composite grades. The baseline adjustment approach will be applied and resulting maximum baseline-adjusted grade will be reported by symptomatic adverse events (AE) as the proportion of patients with at least one grade \>=1 AE during the first 8 weeks. The proportion of patients with at least one grade \>= 3 AE per symptomatic AE will also be tabulated during the first 8 weeks. Comparisons between arms will employ Fisher's exact tests. Additional summaries over the 24 weeks by tables and graphics will also be generated.

Will be measured by the General Physical-5 (GP5). The frequency and relative frequency of patient responses to the GP5 at 8 weeks will be computed by arm and compared between arms using a chi-squared test. The categorical analysis will also be computed at other assessment time points. Mean GP5 scores over time will also be explored using a general linear mixed model and mean plots.

The maximum grade for each type of adverse event will be summarized using CTCAE version 5.0. The frequency and percentage of grade 3+ adverse events (by individual AEs and overall) will be reported by arm and compared between arms using a Fisher's exact test.

The proportion of patients with an emergency room visit or hospitalization will be computed per arm and compared between arms using a Fisher's exact test. In subsequent analyses, emergency room visits and hospitalizations will be explored separately. Proportion of patients with emergency room visits or hospitalizations will also be summarized over the entire study.

Will be estimated using the Kaplan-Meier method and compared between arms using a log-rank test.

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization
Comparison of In-Home Versus In-Clinic Administration of Subcutaneous Nivolumab Through Cancer CARE (Connected Access and Remote Expertise) Beyond Walls (CCBW) Program	NCT06265285	Advanced Esopha... Advanced Renal ... Clinical Stage ... Clinical Stage ... Clinical Stage ... Clinical Stage ... Clinical Stage ... Clinical Stage ... Clinical Stage ... Esophageal Carc... Gastroesophagea... Hepatocellular ... Locally Advance... Lung Non-Small ... Malignant Solid... Metastatic Colo... Metastatic Cuta... Metastatic Esop... Metastatic Head... Metastatic Urot... Recurrent Esoph... Recurrent Head ... Renal Cell Carc... Stage III Renal... Stage IV Colore... Stage IV Cutane... Stage IV Renal ... Unresectable Cu... Unresectable Es... Urothelial Carc...	Home Health Enc... Nivolumab Patient Monitor... Questionnaire A...	18 Years -	Mayo Clinic
Comparison of In-Home Versus In-Clinic Administration of Subcutaneous Nivolumab Through Cancer CARE (Connected Access and Remote Expertise) Beyond Walls (CCBW) Program	NCT06265285	Advanced Esopha... Advanced Renal ... Clinical Stage ... Clinical Stage ... Clinical Stage ... Clinical Stage ... Clinical Stage ... Clinical Stage ... Clinical Stage ... Esophageal Carc... Gastroesophagea... Hepatocellular ... Locally Advance... Lung Non-Small ... Malignant Solid... Metastatic Colo... Metastatic Cuta... Metastatic Esop... Metastatic Head... Metastatic Urot... Recurrent Esoph... Recurrent Head ... Renal Cell Carc... Stage III Renal... Stage IV Colore... Stage IV Cutane... Stage IV Renal ... Unresectable Cu... Unresectable Es... Urothelial Carc...	Home Health Enc... Nivolumab Patient Monitor... Questionnaire A...	18 Years -	Mayo Clinic
At-Home Cancer Directed Therapy Versus in Clinic for the Treatment of Patients With Advanced Cancer	NCT05969860	Advanced Anal C... Advanced Biliar... Advanced Bladde... Advanced Breast... Advanced Carcin... Advanced Cervic... Advanced Colore... Advanced Gastri... Advanced Gliobl... Advanced Head a... Advanced HER2 P... Advanced Lung C... Advanced Lung S... Advanced Malign... Advanced Malign... Advanced Neuroe... Advanced Ovaria... Advanced Pancre... Advanced Prosta... Advanced Prosta... Hematopoietic a... Multiple Myelom... Myelodysplastic...	Clinical Encoun... Home Health Enc... Quality-of-Life... Questionnaire A...	18 Years -	Mayo Clinic

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