Nivolumab plus cabozantinib

An open-label, phase III, randomized controlled trial (NCT03141177) compared sunitinib with nivolumab plus cabozantinib. The study enrolled 651 patients who had received no previous systemic therapy for metastatic disease.[47]

An open-label, phase III, randomized controlled trial (NCT03141177) compared sunitinib with nivolumab plus cabozantinib. The study enrolled 651 patients who had received no previous systemic therapy for metastatic disease.[47]

With a median follow-up of 32.9 months, the OS was 37.7 months in the nivolumab-plus-cabozantinib arm, compared with 34.3 months in the sunitinib arm (HR, 0.70; 95% CI, 0.55–0.90).[47][Level of evidence A1]

An open-label, phase III, randomized controlled trial (NCT03141177) compared sunitinib with nivolumab plus cabozantinib. The study enrolled 651 patients who had received no previous systemic therapy for metastatic disease.[47]

The median PFS was also longer in the nivolumab-plus-cabozantinib arm than in the sunitinib arm (16.6 months vs. 8.3 months; HR, 0.51; 95% CI, 0.41–0.64; P < .001).

An open-label, phase III, randomized controlled trial (NCT03141177) compared sunitinib with nivolumab plus cabozantinib. The study enrolled 651 patients who had received no previous systemic therapy for metastatic disease.[47]

The objective response rate was 55.7% for patients who received combination therapy, compared with 27.1% for patients who received sunitinib (P < .001).

An open-label, phase III, randomized controlled trial (NCT03141177) compared sunitinib with nivolumab plus cabozantinib. The study enrolled 651 patients who had received no previous systemic therapy for metastatic disease.[47]

Grade 3 or higher adverse event rates were reported in 65% of patients who received nivolumab plus cabozantinib, compared with 54% of those who received sunitinib. High-grade treatment-related serious adverse events were reported in 22% of patients in the combination therapy arm and 10% of patients in the sunitinib arm. At least one of the trial drugs was discontinued in 19.7% of those assigned to combination therapy, compared with 16.9% of those assigned to sunitinib. The most common high-grade toxicities with combination therapy were hypertension (12.5%), hyponatremia (9.4%), diarrhea (6.9%), elevated lipase (6.2%), and hypophosphatemia (5.9%).