Clinical Trials

Inclusion Criteria

• Age ≥ 18 years.
• Female or male patients with histologically confirmed malignancies for which treatment with intravenous Nivolumab is currently FDA approved and who are recommended to initiate treatment with single agent 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 or more of the following indications:
  • Completely resected stage II, III or IV melanoma;
  • Urothelial carcinoma status post radical resection.
  • 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 and who are willing to switch to subcutaneous Nivolumab:
  • 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 4 cycles of Ipilimumab and Nivolumab combination 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 metastatic non-small cell lung cancer (NSCLC) whose tumors express PD-L1 (≥1%) as determined by an FDA-approved test, with no EGFR or ALK genomic tumor aberrations;
  • First-line treatment of adult patients with intermediate or poor risk advanced renal cell carcinoma (RCC);
  • Unresectable or metastatic cutaneous melanoma;
  • First-line treatment of adult patients with unresectable malignant pleural mesothelioma (MPM);
  • 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.
• Residing within 35 miles of clinic (hub) or within the area serviced by supplier and paramedic network.
• Residence either has wifi or is within the cellular data network accessible by the study provided devices to enable a reliable connection with the remote command center.
• Signed Informed Consent Form by patient.
• Willing and able to comply with the study protocol in the investigator’s judgment
• ECOG Performance Status (PS) 0 or 1.
• Ability to complete questionnaire(s) by themselves or with assistance.

Pre-Registration – Exclusion Criteria:

• 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.
•  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 within 4 weeks prior to registration including, but not limited to, hospitalization for complications of infections should not be enrolled in the trial (in the current situation, this also applies to patients with suspected or confirmed COVID-19 infection).
• Anticipation of the need for major surgery during the course of study treatment.

Note: Other protocol defined Inclusion/Exclusion Criteria may apply.

Eligibility last updated 9/12/23. Questions regarding updates should be directed to the study team contact.