Primary Tumor Ablation and Outcome in Metastatic Renal Cell Carcinoma Treated With Immunotherapy Combinations.
This study tests whether removing the primary kidney tumor improves survival in patients with advanced kidney cancer that has spread to other parts of the body and who have responded well to immunotherapy treatment. Patients will be randomly assigned to either continue their current immunotherapy alone or to have surgery to remove their primary tumor followed by continued immunotherapy.
Key Objective:The trial is testing whether surgical removal of the primary tumor in addition to standard immunotherapy can improve overall survival in patients with metastatic renal cell carcinoma.
Who to Consider:Patients with advanced kidney cancer that has spread elsewhere in the body who have shown initial positive response to immunotherapy (anti-PD1-based treatment) should consider enrolling.
Trial Parameters
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Brief Summary
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.
Eligibility Criteria
Inclusion Criteria: 1. Informed consent obtained before any study-specific procedures. Patients must be able to understand and be willing to sign a written informed consent. 2. Male or female patient ≥18 years of age. 3. Histological or cytological documentation of renal cell carcinoma with predominantly clear cell histology. 4. Evidence of primary renal cancer. 5. Measurable or not measurable metastatic disease according to Response Evaluation Criteria in Solid Tumors criteria, version 1.1 \[22\]. 6. Eastern Cooperative Oncology Group performance status of ≤1. 7. Life expectancy of at least 9 months. 8. 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 \[21\]. 9. Eligible to continue the