OncoMatch/Clinical Trials/NCT05817903
Axitinib Intensification Plus Nivolumab or Nivolumab Alone After Nivolumab Plus Ipilimumab in mRCC Patients
Is NCT05817903 recruiting? Yes, currently enrolling (May 2026). This Phase 2 trial studies multiple treatments including Axitinib and Nivolumab for metastatic renal cell carcinoma.
Treatment: Axitinib · Nivolumab — 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.
Check if I qualifyExtracted eligibility criteria
Cancer type
Renal Cell Carcinoma
Disease stage
Metastatic disease required
Performance status
ECOG 0–1(Restricted strenuous activity)
Prior therapy
Must have received: anti-PD-1 therapy plus anti-CTLA-4 therapy (nivolumab, ipilimumab) — induction
candidate to receive nivolumab after nivolumab plus ipilimumab induction as per standard clinical practice; Completion of the induction of nivolumab and ipilimumab without toxicity ≥ G2 and no complete response or progressive disease
Cannot have received: systemic therapy
Exception: exclusion of the induction of nivolumab and ipilimumab
Prior treatment with systemic therapy for advanced RCC with the exclusion of the induction of nivolumab and ipilimumab
Cannot have received: adjuvant therapy
Prior adjuvant or neoadjuvant therapy
Cannot have received: neoadjuvant therapy
Prior adjuvant or neoadjuvant therapy
Lab requirements
Blood counts
ANC ≥ 1500/mm3; Platelets ≥ 100,000/mm3; Haemoglobin ≥ 9 g/dL
Kidney function
Serum creatinine ≤ 2.0 × ULN or calculated creatinine clearance ≥ 30 mL/min using Cockroft-Gault
Liver function
ALT and AST < 3.0 × upper limit of normal; Total bilirubin ≤ 1.5 × ULN (≤ 3 mg/dL for Gilbert's disease)
Adequate organ and bone marrow function based upon meeting all of the following laboratory criteria within 10 days before the start of treatment
Structured fields extracted by AI. May contain errors — verify against the official protocol.
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