OncoMatch/Clinical Trials/NCT06265285
Comparison of In-Home Versus In-Clinic Administration of Subcutaneous Nivolumab Through Cancer CARE (Connected Access and Remote Expertise) Beyond Walls (CCBW) Program
Is NCT06265285 recruiting? Yes, currently enrolling (May 2026). This Phase 2 trial studies Nivolumab for advanced esophageal squamous cell carcinoma.
Treatment: Nivolumab — 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.
Check if I qualifyExtracted eligibility criteria
Cancer type
Esophageal Carcinoma
Renal Cell Carcinoma
Melanoma
Gastric Cancer
Hepatocellular Carcinoma
Urothelial Carcinoma
Non-Small Cell Lung Carcinoma
Tumor Agnostic
Colorectal Cancer
Head and Neck Squamous Cell Carcinoma
Biomarker criteria
Required: EGFR wild-type
no known epidermal growth factor receptor (EGFR) mutations
Required: ALK wild-type
no known...anaplastic lymphoma kinase (ALK) rearrangements
Required: MSH2 deficient
mismatch repair deficient (dMMR)
Required: MSH6 deficient
mismatch repair deficient (dMMR)
Required: MLH1 deficient
mismatch repair deficient (dMMR)
Required: PMS2 deficient
mismatch repair deficient (dMMR)
Required: MSI high
Microsatellite instability-high (MSI-H)
Disease stage
Required: Stage IIB, IIC, III, IV (AJCC v8)
Completely resected stage IIB/C, III or IV melanoma; Unresectable advanced, recurrent or metastatic esophageal squamous cell carcinoma; Locally advanced or metastatic urothelial carcinoma; Unresectable or metastatic cutaneous melanoma; Recurrent or metastatic squamous cell carcinoma of the head and neck; Microsatellite instability-high (MSI-H) or mismatch repair deficient (dMMR) metastatic colorectal cancer; Hepatocellular carcinoma (HCC) previously treated with sorafenib
Performance status
ECOG 0–1(Restricted strenuous activity)
Prior therapy
Must have received: platinum-based chemotherapy
Non-small cell lung cancer (NSCLC) with progression on or after platinum-based chemotherapy
Must have received: fluoropyrimidine- and platinum-based chemotherapy
Unresectable advanced, recurrent or metastatic esophageal squamous cell carcinoma (ESCC) after prior fluoropyrimidine- and platinum-based chemotherapy
Must have received: platinum-containing chemotherapy
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
Must have received: platinum-based therapy
Recurrent or metastatic squamous cell carcinoma of the head and neck (SCCHN) with disease progression on or after platinum-based therapy
Must have received: fluoropyrimidine, oxaliplatin, and irinotecan
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
Must have received: anti-angiogenic therapy
Renal cell carcinoma (RCC) patients who have received prior anti-angiogenic therapy
Must have received: sorafenib (sorafenib)
Hepatocellular carcinoma (HCC) previously treated with sorafenib
Lab requirements
Blood counts
ANC ≥ 1500/μL; Platelet count ≥ 100,000/μL; Hemoglobin ≥ 9 g/dL
Kidney function
Serum creatinine ≤ 2.0 × ULN or calculated creatinine clearance ≥ 30 mL/min
Liver function
AST ≤ 3 × ULN (≤ 5 × ULN with liver metastasis); ALT ≤ 3 × ULN (≤ 5 × ULN with liver metastasis); Serum total bilirubin ≤ 1.5 × ULN (≤ 2 × ULN for Gilbert's syndrome or with liver metastasis)
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; Serum creatinine ≤ 2.0 x the ULN for the reference laboratory or a calculated creatinine clearance of ≥ 30 mL/min
Structured fields extracted by AI. May contain errors — verify against the official protocol.
US trial sites
- Mayo Clinic in Florida · Jacksonville, Florida
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