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

PHASE4RecruitingINTERVENTIONAL
Enrollment

409

Participants

Timeline

Start Date

June 15, 2025

Primary Completion Date

October 1, 2027

Study Completion Date

April 1, 2028

Conditions
Renal Cell CancerKidney NeoplasmImmunotherapyKidney CancerSurgery ProgrammedRadiotherapy
Interventions
PROCEDURE

Deferred Cytoreductive Nephrectomy + medical treatment

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.

RADIATION

Radiotherapy + medical treatment

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.

DRUG

Medical therapy

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.

Trial Locations (1)

00168

RECRUITING

Fondazione Policlinico Universitario A. Gemelli IRCCS, Roma

All Listed Sponsors
collaborator

AIRC (Italian Association for Cancer Research)

UNKNOWN

lead

Fondazione Policlinico Universitario Agostino Gemelli IRCCS

OTHER