ASCO 2026 | Phase II trial of cabozantinib and nivolumab in non-clear cell renal cell carcinoma
Darren Feldman, MD, Memorial Sloan Kettering Cancer Center, New York, NY, presents final results of a Phase II trial (NCT03635892) evaluating cabozantinib plus nivolumab in advanced non-clear cell renal cell carcinoma (nccRCC). The combination demonstrated meaningful overall response rates and progression-free survival in papillary, unclassified, and translocation-associated histologies, with particularly notable activity in fumarate hydratase-deficient tumors. Objective responses were not observed in chromophobe RCC, suggesting histology-dependent efficacy. The safety profile was consistent with previously reported data for this combination. This interview took place during the 2026 American Society of Clinical Oncology (ASCO) Meeting in Chicago, IL.
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Transcript
This is a single center, phase two investigator-initiated trial, in which we tested the combination of cabozantinib plus nivolumab in patients with non-clear cell RCC. It was set up into two cohorts. One cohort had patients with chromophobe RCC, and the other had patients with papillary or unclassified with papillary features or unclassified without papillary features, as well as FH-deficient and translocation-associated RCC...
This is a single center, phase two investigator-initiated trial, in which we tested the combination of cabozantinib plus nivolumab in patients with non-clear cell RCC. It was set up into two cohorts. One cohort had patients with chromophobe RCC, and the other had patients with papillary or unclassified with papillary features or unclassified without papillary features, as well as FH-deficient and translocation-associated RCC. And what we found was that there were no responses in the chromophobe group, and that group closed early as one cohort. But we did see significant activity with cabozantinib plus nivolumab in patients with the other histologies mentioned. We had an overall response rate of about 43%. And in the first line, we included patients who were both previously treated and untreated. And in the patients who were treated in the first-line setting, our results showed about a 46% response rate. We also saw that in a particular subset of patients known as FH-deficient RCC, seven out of eight of them had a response, so about an 88% response rate in that small subgroup of patients.
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