OncoMatch/Clinical Trials/NCT06903312
Primary Tumor Ablation and Outcome in Metastatic Renal Cell Carcinoma Treated With Immunotherapy Combinations.
Is NCT06903312 recruiting? Yes, currently enrolling (May 2026). This Phase 4 trial studies Medical therapy for renal cell cancer.
Treatment: Medical therapy — This is Phase IV, randomized, multi arm, multicenter, low interventional clinical trial, aiming to evaluate if treatment of primary tumor in mRCC patients with initial benefit to anti-PD1- based therapy (SOC) can improve the overall survival. All patients eligible according to inclusion and exclusion criteria will be enrolled and randomized to different treatment options based on tumor extension of the primary kidney cancer. Those with primary kidney cancer ≤ 4 cm will be randomized 1:1:1 to receive: * Cytoreductive Nephrectomy + standard of care (SOC) or * RT on primary tumor + SOC or SOC alone. Those with primary kidney cancer \> 4 cm will be randomized 1:1 to receive: • Deferred Cytoreductive Nephrectomy + SOC or SOC alone. Patients randomized to Deferred Cytoreductive Nephrectomy can be treated with one among radical nephrectomy; partial nephrectomy or lumpectomy. Patients randomized to RT should be treated with single shot of 25 Gy (or with multiple fractions with equivalent biological dose). The SOC medical therapy is the continuation of the combination of medical therapy for mRCC including one of the available combination among axitinib + pembrolizumab or cabozantinib + nivolumab or lenvatinib + pembrolizumab or nivolumab alone after nivolumab + ipilimumab.
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 (axitinib + pembrolizumab, cabozantinib + nivolumab, lenvatinib + pembrolizumab, nivolumab alone after nivolumab + ipilimumab) — metastatic or locally advanced
Under treatment with one anti-PD1 based therapy (SOC) among axitinib + pembrolizumab or cabozantinib + nivolumab or lenvatinib + pembrolizumab or nivolumab alone after nivolumab + ipilimumab for at least 24 but not more than 52 weeks at the time of the signed informed consent and without evidence of progressive disease based on RECIST criteria v 1.1
Cannot have received: systemic therapy for metastatic or locally advanced renal cell carcinoma
Exception: current anti-PD-1 based therapy as specified is allowed
More than one treatment for metastatic or locally advanced renal cell carcinoma
Lab requirements
Blood counts
Platelet count ≥100,000/mm3, hemoglobin >9 g/dl, absolute neutrophil count >1,500/mm3
Kidney function
Creatinine <2.5 mg/dl and creatinine clearance >30 ml/min (Cockcroft-Gault Formula)
Liver function
Total bilirubin ≤1.5 × ULN; ALT and AST ≤2 × ULN (≤5 × ULN for patients with liver involvement); alkaline phosphatase ≤2.5 × ULN (≤5 × ULN for patients with liver involvement)
Adequate bone-marrow, liver, and renal function as assessed by the following laboratory requirements conducted within 7 days of starting to study treatment: Creatinine value <2.5 mg/dl and creatinine clearance > 30 ml/min evaluated by the Cockcroft-Gault Formula. Total bilirubin ≤1.5 × ULN; ALT and AST ≤2 × ULN (≤5 × ULN for patients with liver involvement); INR and PTT ≤1.5 × ULN. Platelet count ≥100,000/mm3, hemoglobin >9 g/dl, absolute neutrophil count >1,500/mm3; alkaline phosphatase ≤2.5 × ULN (≤5 × ULN for patients with liver involvement).
Structured fields extracted by AI. May contain errors — verify against the official protocol.
Could you qualify for this trial?
Enter your biomarker results to see how this trial's eligibility criteria match your specific cancer profile.
Check if I qualify