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. 2020 Oct 14;2020(10):CD012796. doi: 10.1002/14651858.CD012796.pub2

Choueiri 2019.

Study name NCT03937219, Cosmic‐313
Methods Study type: multicentre RCT
Phase: 3
Accrual period: 25 June 2019 ‐
Blinding: double‐blind study design
Strata: IMDC risk score and geographic region
IMC: data not found
Crossover: data not found
Participants Histology: clear cell component
Prior systemic therapy: no prior systemic therapy for RCC
Measurable disease: required
Eligible PS: Karnofsky PS 70% or better
Non metastatic %: data not found
M/F %: data not found
Age median (range): data not found
Prior nephrectomy: data not found
Prognostic strata: system, good/intermediate/poor risk %: data not found
Interventions Cabozantinib + nivolumab + ipilimumab (4 doses) followed by cabozantinib + nivolumab vs Cabozantinib‐matched placebo + nivolumab + ipilimumab (4 doses) followed by cabozantinib‐matched placebo + nivolumab
Outcomes PFS: primary endpoint
OS: secondary end point
AE:
QoL:
RR:
Other:
Starting date June 2019
Contact information  
Notes