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Studies

Interventional Recruiting Phase 4

NCT06903312 on ClinicalTrials.gov

Primary Tumor Ablation and Outcome in Metastatic Renal Cell Carcinoma Treated With Immunotherapy Combinations.

Official title: Clinical and Humoral Impact of Primary Tumor Ablation in Metastatic Renal Cell Carcinoma Treated With Immunotherapy. The ITALIC-RCC Randomized Study.

  • Sponsor: Agostino Gemelli University Polyclinic
  • Collaborators: AIRC (Italian Association for Cancer Research)
  • Enrollment: 409 (Estimated)
  • Study start: 2025-06-15 (Actual)
  • Primary completion: 2027-10-01 (Estimated)
  • Study completion: 2028-04-01 (Estimated)
  • Allocation: Randomized
  • InterventionModel: Parallel
  • InterventionModelDescription: Patients will be valuated for local therapy (ie: surgery or radiotherapy) while they are receiving immunotherapy-based therapy.
  • Masking: None
  • PrimaryPurpose: Treatment

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.

Conditions

  • Renal Cell Cancer
  • Kidney Neoplasm
  • Immunotherapy
  • Kidney Cancer
  • Surgery Programmed
  • Radiotherapy

Intervention / Treatment

  • Procedure: Deferred Cytoreductive Nephrectomy + medical treatment
  • Radiation: Radiotherapy + medical treatment
  • Drug: Medical therapy

Primary Outcome Measures

  • 30-months Overall Survival for surgery vs. control (30 months)
    The primary endpoint of the study is to assess the difference in 30-months overall survival (OS) between patients who receive or not the deferred citoreductive nephrectomy (CN) while on therapy with SOC for mRCC.

Countries

Italy

Locations and Investigators

  • Fondazione Policlinico Universitario A. Gemelli IRCCS, Roma, Italy (Recruiting)

Study Officials