| Eligibility |
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
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