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 |