Efficacy
PD, tumor, clear-cell renal cell carcinoma, non-clear cell renal cell carcinoma
EVENTS, TUMOR, BEST
Thirty-eight patients were evaluable for tumor response at the RP2D (pembrolizumab 200 mg i.v. every 3 weeks and cabozantinib 60 mg orally daily). The ORR was 65.8% (25/38 patients, 95% CI, 49.9–78.8) with 1 CR, 24 PR, 12 SD, 1 PD. The ORR was 78.6% (11/14) in evaluable patients who received study treatment as 1 L therapy and 58.3% (14/24) among patients who received it as second- or subsequent-line therapy. By type or prior therapy, the ORR was 37.5% in patients who had previously received VEGF/R inhibitor only, 62.5% in patients with prior CPI only, 75% in patients who had received both VEGF/R inhibitor and CPI (either in combination or sequentially), and 78.6% in patients who had received no prior therapy (Best response by RECIST in evaluable patients treated at RP2D (pembrolizumab 200 mg i.v. every 3 weeks and cabozantinib 60 mg orally once daily).Abbreviations: ccRCC, clear-cell renal cell carcinoma; nccRCC, non-clear cell renal cell carcinoma.Clinical activity of pembrolizumab and cabozantinib. All 40 patients treated at the RP2D were included in the survival analyses. There were 33 PFS events and 16 OS events. The median PFS was 10.45 months (95% CI, 6.25–14.63; Kaplan–Meier curves of PFS (