Comparison of In-Home Versus In-Clinic Administration of Subcutaneous Nivolumab Through Cancer CA… (NCT06265285) | Clinical Trial Compass
RecruitingPhase 2
Comparison of In-Home Versus In-Clinic Administration of Subcutaneous Nivolumab Through Cancer CARE (Connected Access and Remote Expertise) Beyond Walls (CCBW) Program
United States50 participantsStarted 2024-04-30
Plain-language 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.
Who can participate
Age range18 Years
SexALL
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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. Additionally, patients who are currently receiving single-agent IV nivolumab are eligible, provided they transition to subcutaneous nivolumab on-study, with their first subcutaneous (subQ) dose administered on cycle 1, day 1 of the study.
* 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…
What they're measuring
1
Change in patient-reported rating of Cancer CARE Cancer Connected Access and Remote Expertise (CARE) after 8 weeks
Timeframe: At baseline and up to 24 weeks of in clinic or at home care