Trial Title:
Comparison of In-Home Versus In-Clinic Administration of Subcutaneous Nivolumab Through Cancer CARE (Connected Access and Remote Expertise) Beyond Walls (CCBW) Program
NCT ID:
NCT06265285
Condition:
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
Conditions: Official terms:
Carcinoma
Colorectal Neoplasms
Melanoma
Carcinoma, Squamous Cell
Carcinoma, Renal Cell
Carcinoma, Transitional Cell
Squamous Cell Carcinoma of Head and Neck
Esophageal Squamous Cell Carcinoma
Esophageal Neoplasms
Melanoma, Cutaneous Malignant
Skin Neoplasms
Carcinoma, Non-Small-Cell Lung
Recurrence
Nivolumab
Study type:
Interventional
Study phase:
Phase 2
Overall status:
Recruiting
Study design:
Allocation:
N/A
Intervention model:
Single Group Assignment
Primary purpose:
Health Services Research
Masking:
None (Open Label)
Intervention:
Intervention type:
Other
Intervention name:
Home Health Encounter
Description:
Receive in-home visits by a home health nurse
Arm group label:
Health services research (in-clinic and at-home nivolumab)
Other name:
HH
Other name:
Home
Other name:
Home Care Visit
Other name:
Home Health
Intervention type:
Biological
Intervention name:
Nivolumab
Description:
Given SC
Arm group label:
Health services research (in-clinic and at-home nivolumab)
Other name:
ABP 206
Other name:
BMS-936558
Other name:
CMAB819
Other name:
MDX-1106
Other name:
NIVO
Other name:
Nivolumab Biosimilar ABP 206
Other name:
Nivolumab Biosimilar CMAB819
Other name:
ONO-4538
Other name:
Opdivo
Intervention type:
Procedure
Intervention name:
Patient Monitoring
Description:
Undergo remote patient monitoring
Arm group label:
Health services research (in-clinic and at-home nivolumab)
Other name:
medical monitoring
Other name:
monitor
Intervention type:
Other
Intervention name:
Questionnaire Administration
Description:
Ancillary studies
Arm group label:
Health services research (in-clinic and at-home nivolumab)
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.
Detailed 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.
Criteria for eligibility:
Criteria:
Inclusion Criteria:
- 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:
- Single agent nivolumab administered in the adjuvant setting for one of the
following indications:
- Completely resected stage IIB/C, III or IV melanoma
- Urothelial carcinoma status post radical resection and have a high risk of
recurrence
- Completely resected esophageal or gastroesophageal junction carcinoma with
residual pathologic disease in adult patients who have received
neoadjuvant chemoradiotherapy (CRT)
- Single agent nivolumab for advanced/metastatic cancer for one or more of the
following indications:
- Renal cell carcinoma (RCC) patients who have received prior
anti-angiogenic therapy
- Non-small cell lung cancer (NSCLC) with progression on or after
platinum-based chemotherapy (Note: patients with EGFR or ALK genomic tumor
aberrations should have disease progression on FDA-approved therapy for
these aberrations prior to receiving nivolumab)
- Unresectable advanced, recurrent or metastatic esophageal squamous cell
carcinoma (ESCC) after prior fluoropyrimidine- and platinum-based
chemotherapy
- Unresectable or metastatic cutaneous melanoma
- Locally advanced or metastatic urothelial carcinoma who have disease
progression during or following platinum-containing chemotherapy or have
disease progression within 12 months of neoadjuvant or adjuvant treatment
with platinum-containing chemotherapy
- Recurrent or metastatic squamous cell carcinoma of the head and neck
(SCCHN) with disease progression on or after platinum-based therapy
- Microsatellite instability-high (MSI-H) or mismatch repair deficient
(dMMR) metastatic colorectal cancer (CRC) that has progressed following
treatment with a fluoropyrimidine, oxaliplatin, and irinotecan
- Patients transitioning to maintenance nivolumab and who are willing to switch
to subcutaneous nivolumab after completion of Ipilimumab and nivolumab
combination therapy for one or more of the indications listed below (Note:
patients who discontinue ipilimumab for immune-related toxicities, but are
deemed to be eligible to continue on single agent nivolumab maintenance by
their treating oncologist are eligible):
- First-line treatment of adult patients with intermediate or poor risk
advanced renal cell carcinoma (RCC)
- Unresectable or metastatic cutaneous melanoma
- Hepatocellular carcinoma (HCC) previously treated with sorafenib
- Microsatellite instability-high (MSI-H) or mismatch repair deficient
(dMMR) metastatic colorectal cancer (CRC) that has progressed following
treatment with a fluoropyrimidine, oxaliplatin, and irinotecan
- Patients have recovered from the effects of any previous chemotherapy,
immunotherapy, other prior systemic anticancer therapy, radiotherapy, and/or surgery
(i.e., residual toxicity no worse than grade 1 [grade 2 treatment-associated
peripheral neuropathy, grade 2 fatigue and/or any grade of alopecia are acceptable
assuming all other inclusion criteria are met]) before registration
- Eastern Cooperative Oncology Group (ECOG) performance status (PS) 0 or 1
- Aspartate transaminase (AST) values ≤ 3 × the upper limit of normal (ULN). For
patients with documented baseline liver metastasis, the following limits will apply:
5 × ULN for transaminase
- Alanine transaminase (ALT) values ≤ 3 x the upper limit of normal (ULN). For
patients with documented baseline liver metastasis, the following limits will apply:
5 x ULN for transaminase
- Serum total bilirubin values of ≤ 1.5 x ULN ( ≤ 2 x ULN for patients with known
Gilbert's syndrome). For patients with documented baseline liver metastasis, the
following limits will apply: 2 x ULN for bilirubin
- Absolute neutrophil count (ANC) of ≥ 1500/μL
- Platelet count of ≥ 100,000/μL
- Hemoglobin of ≥ 9 g/dL (patients may be transfused to this level, if necessary, but
transfusion must occur > 1 week prior to registration)
- Serum creatinine ≤ 2.0 x the ULN for the reference laboratory or a calculated
creatinine clearance of ≥ 30 mL/min by the Cockcroft-Gault Equation measured ≤ 7
days prior to registration
- Patients are residing ≤ 35 miles of clinic (hub) or within the area serviced by
supplier and paramedic network
- Residence has Wi-Fi to enable a reliable connection with the remote command center
- Patients have signed Informed Consent Form (ICF)
- Patients are willing and able to comply with the study protocol in the
investigator's judgment
- Patients are able and willing to complete study questionnaire(s) by themselves or
with assistance
- Women of childbearing potential (WOCBP) must:
- Have a negative pregnancy test (serum or urine) ≤ 3 days before the first dose
of study drug
- Be agreeable to use a contraceptive method that is highly effective during the
intervention period and for at least 5 months after the last dose and agrees
not to donate eggs (ova, oocytes) for the purpose of reproduction for the same
time period
Exclusion Criteria:
- 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
- Uncontrolled intercurrent illness including, but not limited to:
- Ongoing or active infection
- Symptomatic congestive heart failure
- Unstable angina pectoris
- Cardiac arrhythmia
- Myocardial infarction ≤ 6 months
- Wound healing disorder
- Psychiatric illness/social situations that would limit compliance with study
requirements
- Patients with any severe infection ≤ 4 weeks prior to registration including, but
not limited to, hospitalization for complications of infections
- Patients with an active, known or suspected autoimmune disease. Patients with type I
diabetes mellitus, hypothyroidism only requiring hormone replacement, skin disorders
(such as vitiligo, psoriasis, or alopecia) not requiring systemic treatment, or
conditions not expected to recur in the absence of an external trigger are permitted
to enroll. Replacement therapy (e.g., thyroxine, insulin, or physiologic
corticosteroid replacement therapy for adrenal or pituitary insufficiency) is not
considered a form of systemic treatment. Patients with vitiligo, Graves' disease, or
psoriasis not requiring systemic treatment within the past 30 days are not excluded.
Patients with celiac disease controlled with diet modification are not excluded
- Patients with a condition requiring systemic treatment with either corticosteroids (
> 10 mg daily prednisone equivalent) ≤ 14 days or other immunosuppressive
medications ≤ 30 days prior to registration. Inhaled or topical steroids, and
adrenal replacement steroid doses > 10 mg daily prednisone equivalent, are permitted
in the absence of active autoimmune disease
- Concurrent malignancy (present during screening) requiring treatment or history of
prior malignancy active ≤ 2 years prior to registration (i.e., participants with a
history of prior malignancy are eligible if treatment was completed at least 2 years
before randomization/treatment assignment and the patient has no evidence of
disease). Participants with history of prior early stage basal/squamous cell skin
cancer or non-invasive or in situ cancers that have undergone definitive treatment
at any time are also eligible
- Patients have undergone prior solid organ and/or non-autologous hematopoietic stem
cell or bone marrow transplant
- Patients with active brain metastases or leptomeningeal metastases, aside from the
exceptions below. Participants with brain metastases are eligible if they are:
- Asymptomatic
- Have been treated and participants have neurologically returned to baseline
(except for residual signs or symptoms related to the central nervous system
[CNS] treatment), and
- There is no MRI evidence of progression for at least 4 weeks after CNS directed
therapy is complete and ≤ 28 days prior to registration
- In addition, participants must have been either off corticosteroids, or on a
stable or decreasing dose of ≤ 10 mg daily prednisone (or equivalent) for at
least 2 weeks prior to registration
- Participants with brain disease treated with whole brain radiation
- Anticipation of the need for major surgery during the course of study treatment
- Participants who are pregnant or breastfeeding
- Treatment with any live attenuated vaccines ≤ 30 days of registration (vaccines that
are not live attenuated are allowed, including COVID-19 vaccine)
- Known human deficiency virus (HIV) positive with an AIDS defining opportunistic
infection within the last year, or a current CD4 count < 350 cells/uL, aside from
the exceptions below. Participants with HIV are eligible if:
- They have received antiviral therapy (ART) for at least 4 weeks prior to
treatment assignment as clinically indicated while enrolled in the study
- They continue on ART as clinically indicated while enrolled on study
- CD4 counts and viral load are monitored per standard of care by a local
healthcare provider
- History of allergy or hypersensitivity to study drug components
- Any positive test result for hepatitis B virus (HBV) indicating presence of virus
(e.g., hepatitis B surface antigen [HBsAg, Australia antigen]) positive
- Any positive test result for hepatitis C virus (HCV) indicating presence of active
viral replication (detectable HCV-ribonucleic acid [RNA]). Note: Participants with
positive HCV antibody and an undetectable HCV RNA are eligible to enroll
Gender:
All
Minimum age:
18 Years
Maximum age:
N/A
Healthy volunteers:
No
Locations:
Facility:
Name:
Mayo Clinic in Florida
Address:
City:
Jacksonville
Zip:
32224-9980
Country:
United States
Status:
Recruiting
Contact:
Last name:
Clinical Trials Referral Office
Phone:
855-776-0015
Email:
mayocliniccancerstudies@mayo.edu
Contact backup:
Last name:
Roxana S. Dronca, M.D.
Start date:
April 30, 2024
Completion date:
December 31, 2026
Lead sponsor:
Agency:
Mayo Clinic
Agency class:
Other
Source:
Mayo Clinic
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT06265285
https://www.mayo.edu/research/clinical-trials
