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

Sponsor
Fondazione Policlinico Universitario Agostino Gemelli IRCCS
Study ID
NCT06903312
Phase
PHASE4
Status
Recruiting
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Conditions

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

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Deferred Cytoreductive Nephrectomy + medical treatment — PROCEDURE
    Patients randomized to Deferred Cytoreductive Nephrectomy can be treated with one among radical nephrectomy; partial nephrectomy or lumpectomy. Patients will continue to receive the ongoing medical treatment before the randomization.
  • Radiotherapy + medical treatment — RADIATION
    Patients randomized to RT should be treated with single shot of 25 Gy (or with multiple fractions with equivalent biological dose). Patients will continue to receive the ongoing medical treatment before the randomization.
  • Medical therapy — DRUG
    Medical therapy is the continuation of the immune-based combo for mRCC including one of the available options among axitinib + pembrolizumab or cabozantinib + nivolumab or lenvatinib + pembrolizumab or nivolumab alone after nivolumab + ipilimumab.

Study Details

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.

Key Dates

First listed
Mar 30, 2025
Start date
Jun 15, 2025
Status verified
Jun 2025
Primary completion
Oct 1, 2027
Completion
Apr 1, 2028

Study Design

Enrollment
409 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: Radiotherapy
    Patients with tumors up to 4 cm can receive RT single shot of 25 Gy (or with multiple fractions with equivalent biological dose).
  • Experimental: Deferred Cytoreductive Nephrectomy
    Patients randomized to Deferred Cytoreductive Nephrectomy can be treated with one among radical nephrectomy; partial nephrectomy or lumpectomy.
  • Active Comparator: Control
    patients in the control arm continue to receive immuno-based medical treatment for mRCC.

Primary Outcome Measure

30-months Overall Survival for surgery vs. control [ Time Frame: 30 months ]

Central Contacts

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