Study in Which Therapy is Either Switched to Nivolumab After 3 Months of Treatment or Therapy is Continued With a Tyrosine Kinase Inhibitor in Patients With Metastatic Renal Cell Carcinoma (RCC) and Disease Control

Summary

Participation Requirements

Description

This is a randomized, open-label, phase II trial. Patients with advanced or metastatic renal cell carcinoma (RCC) will be randomized into two arms either receiving Nivolumab or continuation of the Tyrosin Kinase Inhibitor (TKI) treatment that they have received as 1st-line therapy. Patients must hav...

This is a randomized, open-label, phase II trial. Patients with advanced or metastatic renal cell carcinoma (RCC) will be randomized into two arms either receiving Nivolumab or continuation of the Tyrosin Kinase Inhibitor (TKI) treatment that they have received as 1st-line therapy. Patients must have received first line therapy with a VEGFR-TKI (Sunitinib or Pazopanib) prior to study inclusion for 10-12 weeks with documented disease control (PR/SD) according to RECIST 1.1 at time of study entry. Eligible patients will be randomized 1:1 either in the Nivolumab or in the TKI arm. Dosage of Nivolumab: 240 mg i.v. on D1 of every cycle (Q2W) for 16 weeks. After 16 weeks 480 mg i.v. on D1 of every cycle (Q4W) until disease progress, intolerable toxicity, withdrawal of consent or end of study. Dosage of Sunitinib: According to Standard of Care (SOC). Recommended dose is 50 mg p.o. 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.). Dosage of Pazopanib: According to Standard of Care (SOC). Recommended dose is 800 mg p.o. daily continuously (until disease progress, intolerable toxicity, withdrawal of consent or end of study.).

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