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

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.

Trial Details

NCT ID
NCT05817903
Phase
PHASE2
Sponsor
Consorzio Oncotech
Status
RECRUITING
Cancer Type
Kidney Cancer
Interventions
  • Axitinib
  • Nivolumab
Locations (sample)
  • Brescia, Italy|45.53558,10.21472
  • Candiolo, Italy|44.95858,7.59812
  • Catania, Italy|37.49223,15.07041
  • Cremona, Italy|45.13325,10.02129
  • Florence, Italy|43.77925,11.24626

Key Eligibility Criteria

  • Histologically or cytologically confirmed advanced RCC with predominantly clear-cell subtype and candidate to receive nivolumab after nivolumab plu…
  • Completion of the induction of nivolumab and ipilimumab without toxicity ≥ G2 and no complete response or progressive disease.
  • Male or female subjects aged ≥ 18 years
  • Available tumor tissue sample.

For full eligibility, visit ClinicalTrials.gov.

Check If You May Be Eligible

Trialify translates complex eligibility criteria into plain yes-or-no questions to help you understand if this trial might be right for you.

Find Kidney Cancer Trials on Trialify →