Ignite Creation Date:
2025-12-26 @ 10:44 PM
Ignite Modification Date:
2026-01-01 @ 11:31 AM
Study NCT ID:
NCT06903312
Status:
RECRUITING
Last Update Posted:
2025-07-03
First Post:
2025-03-24
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Primary Tumor Ablation and Outcome in Metastatic Renal Cell Carcinoma Treated With Immunotherapy Combinations.
Sponsor:
Fondazione Policlinico Universitario Agostino Gemelli IRCCS
Organization:
Study Overview
Official Title:
Clinical and Humoral Impact of Primary Tumor Ablation in Metastatic Renal Cell Carcinoma Treated With Immunotherapy. The ITALIC-RCC Randomized Study.
Status:
RECRUITING
Status Verified Date:
2025-06
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
ITALIC-RCC
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.
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.
Detailed Description:
None
Study Oversight
Has Oversight DMC:
False
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
False
Is an FDA AA801 Violation?: