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 |