Study design and data
RCC
BLOOD, RCC
The exposure–response analyses were conducted using data from the phase 3 CheckMate 9ER trial of nivolumab plus cabozantinib versus sunitinib in first-line advanced RCC. CheckMate 9ER was an open-label, randomized phase 3 trial of nivolumab (240 mg intravenously every 2 weeks) plus cabozantinib (40 mg orally QD) versus sunitinib (50 mg orally QD for 4 weeks on treatment, then 2 weeks off) in patients with previously untreated advanced or metastatic RCC [A total of 651 patients were randomized to receive nivolumab plus cabozantinib (Radiographic assessments were performed at screening, Week 12, then every 6 weeks until Week 60, then every 12 weeks until progression. Safety was assessed every 2 weeks. Blood samples for PK assessment of cabozantinib were collected in Cycles 1, 3, 4 and 7 (cycle = 2 weeks for nivolumab), at the same time as pre-dose PK samples for nivolumab, provided the time of the draw was approximately ≥ 8 h after the previous evening dose of cabozantinib to ensure sampling occurred after the T