drugset / Trial / NCT05817903

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

NCT05817903

Phase 2 Recruiting 118 enrolled Consorzio Oncotech Pfizer · collab
RandomizedParallel-groupOpen-labelTreatment

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.

Timeline

Start
2023-04-18
Primary completion
2026-04-01
Completion
2027-04-01

Drugs

EvaluationDrugModalityDoseRoute
Subject Axitinib Small molecule 5 mg Oral
Background Nivolumab Monoclonal antibody 480 mg Intravenous

Indications