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

Grünwald 2018.

Study name NCT02959554, NIVOSWITCH
Methods Study design: multicentre RCT
Phase: 2
Accrual period: data not found
Blinding: open label study design
Strata: data not found
IMC: data not found
Crossover: data not found
Participants Histology: clear cell component
Prior systemic therapy: First‐line treatment with a TKI for 10‐12 weeks (limited to sunitinib or pazopanib)
Eligible PS: ECOG‐PS 0‐2
Measurable disease: required
Non metastatic %: data not found
M/F %: data not found
Age median, years: data not found
Prior nephrectomy: data not found
Prognostic strata: system, good/intermediate/poor risk %: data not found
Interventions Nivolumab: 240 mg iv on D1 of every cycle (Q2W) for 16 weeks. After 16 weeks 480 mg iv on D1 of every cycle (Q4W) until disease progress, intolerable toxicity, withdrawal of consent or end of study versus Sunitinib: According to Standard of Care (SOC). Recommended dose is 50 mg PO once daily for 4 consecutive weeks followed by a 2‐week rest period (schedule 4/2) to comprise a complete cycle of 6 weeks (until disease progress, intolerable toxicity, withdrawal of consent or end of study) or Pazopanib: According to Standard of Care (SOC). Recommended dose is 800 mg PO daily continuously (until disease progress, intolerable toxicity, withdrawal of consent or end of study)
Outcomes PFS: secondary endpoint
OS: primary end point
AE: secondary end point
QoL: secondary endpoint
RR: secondary end point
Other:
Starting date December 2016
Contact information Principal Investigator: Prof. Dr. Viktor Grünwald
Notes