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
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.
• 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
∙ Unresectable or metastatic urothelial carcinoma, as first-line treatment in combination with cisplatin and gemcitabine.
⁃ Subcutaneous nivolumab to be initiated as monotherapy following six cycles of cisplatin + gemcitabine
∙ 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
⁃ Single agent nivolumab administered in the adjuvant setting following neoadjuvant nivolumab with platinum doublet chemotherapy for patients with resectable (tumors ≥ 4 cm and/or node positive) non-small cell lung cancer (NSCLC) and no known epidermal growth factor receptor (EGFR) mutations or anaplastic lymphoma kinase (ALK) rearrangements
• 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