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Updated: Feb 1, 2026

Modeling Spontaneous Metastatic Renal Cell Carcinoma mRCC in Mice Following Nephrectomy
Published on: April 29, 2014
[Initial Clinical Experience of Nivolumab for Metastatic Renal Cell Carcinoma]
Arinobu Fukunaga1, Toshinari Yamasaki1, Tomoya Okuno1
1The Department of Urology, Kyoto University Hospital.
Abstract:
Nivolumab was approved as a new agent for advanced renal cell carcinoma (RCC) in Japan on September 2016. Nivolumab is an immune checkpoint inhibitor that activates the cytotoxic immune response and has exerted antitumor effects in a mechanism different from other available molecular targeted agents. Therefore, its response pattern, efficacy and adverse events are different from those of the molecular targeted agents for RCC. Here, we report our initial clinical experience with nivolumab. From December 2016 to September 2017, we applied nivolumab to 7 patients with metastatic RCC. The most common metastatic site was the lungs, followed by lymph nodes, bones and brain. According to the immune-related response criteria, the efficacy was stable disease in 2 patients and progressive disease in 5 patients. In 5 cases with multiple metastases, responses differed with the site of metastasis. The response was best in lung metastasis and worst in brain metastasis. Six cases had minor adverse events. In two cases, we discontinued administration of nivolumab temporarily. The patients recovered completely and we considered nivolumab effective and safe for treatment of metastatic RCC.
Insights
Nivolumab, an immune checkpoint inhibitor, showed varied efficacy in advanced renal cell carcinoma (RCC) patients. While generally safe with minor side effects, its effectiveness differed across metastatic sites, with lung metastases responding best.
Area of Science:
- Oncology
- Immunotherapy
Background:
- Nivolumab is an immune checkpoint inhibitor approved for advanced renal cell carcinoma (RCC) in Japan.
- Its mechanism differs from traditional molecular targeted agents, suggesting unique efficacy and adverse event profiles.
Purpose of the Study:
- To report the initial clinical experience with nivolumab in patients with metastatic RCC.
- To evaluate the efficacy, safety, and response patterns of nivolumab in advanced RCC.
Main Methods:
- A cohort of 7 patients with metastatic RCC received nivolumab between December 2016 and September 2017.
- Efficacy was assessed using immune-related response criteria, with attention to metastatic site variations.
- Adverse events were monitored throughout the treatment period.
Main Results:
- Stable disease was observed in 2 patients, and progressive disease in 5 patients.
- Response varied by metastatic site, with lung metastases showing the best response and brain metastases the worst.
- Six patients experienced minor adverse events; temporary discontinuation led to complete recovery in two cases.
Conclusions:
- Nivolumab demonstrated a manageable safety profile in metastatic RCC patients.
- The drug's efficacy is site-dependent, highlighting the need for tailored treatment strategies.
- Nivolumab is considered effective and safe for treating metastatic RCC, with distinct response patterns observed.
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