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Table 1 Summary of clinical studies for model development and test application

From: Development of a prognostic composite cytokine signature based on the correlation with nivolumab clearance: translational PK/PD analysis in patients with renal cell carcinoma

Study

Treatment

Dose and schedule

Patient numbera

(total treated)

Analysis

CheckMate 009 (NCT01358721), phase I dose escalation

Nivolumab

0.3, 2, and 10.0 mg/kg, Q3W

N = 89 (91)

Training dataset

CheckMate 025 (NCT01668784), phase III

Nivolumab

3.0 mg/kg, Q2W

N = 391 (406)

Training dataset

Everolimus

10.0 mg as a daily dose

N = 297 (397)

Test dataset

CheckMate 010 (NCT01354431), phase II dose ranging

Nivolumab

0.3, 2, and 10.0 mg/kg, Q3W

N = 156 (167)

Test dataset

  1. aPatients missing cytokine or pharmacokinetics data were excluded from the training and test datasets of the machine-learning model. Q2W every 2 weeks, Q3W every 3 weeks