Axitinib Intensification Plus Nivolumab or Nivolumab Alone After Nivolumab Plus Ipilimumab in mRCC Patients — AxIn  

Metastatic Renal Cell Carcinoma Clinical Trial

Official title: Phase II Study of Axitinib Intensification Plus Nivolumab Compared to Nivolumab Alone After Induction With Nivolumab Plus Ipilimumab in mRCC Patients Without Previous Complete Response (AxIn Study).

Status Recruiting

Clinical Trial Summary

This phase II open label trial randomized patients who completed the induction with nivolumab plus ipilimumab without complete response or progressive disease will be randomized 1:1 to receive axitinib in addition to nivolumab (Arm A) or continue with nivolumab alone (Arm B).Treatment will be continued until progression of disease, unacceptable toxicity, patient's refusal, or physician decision whichever occurred first.

Clinical Trial Description

The present study aims to demonstrate if the addition of axitinib to nivolumab maintenance after nivolumab plus ipilimumab induction can improve the rate of response considering that the incidence of partial response was 32% and 51% in Checkmate214 and Keynote426 trials respectively.

This study requires 106 patients to show an improvement from 30% to 50% of the incidence of partial responses with a power of 80%, and alpha-error 0.10 (one-side p).

Assuming a drop out of 10%, the final estimated number to enroll should be 118 (59 in arm A and 59 in arm B). ;

Related Conditions & MeSH terms

• Carcinoma, Renal Cell
• Metastatic Renal Cell Carcinoma

• NCT number: NCT05817903
• Study type: Interventional
• Source: Consorzio Oncotech
• Contact: Roberto Iacovelli, MD
• Phone: +393339516295
• Email: roberto.iacovelli@policlinicogemelli.it
• Status: Recruiting
• Phase: Phase 2
• Start date: April 18, 2023
• Completion date: April 1, 2027