Actively Recruiting
Clinical and Humoral Impact of Primary Tumor Ablation in Metastatic Renal Cell Carcinoma Treated With Immunotherapy The ITALIC-RCC Randomized Study
Led by Fondazione Policlinico Universitario Agostino Gemelli IRCCS · Updated on 2025-07-03
409
Participants Needed
1
Research Sites
26 weeks
Total Duration
On this page
Sponsors
F
Fondazione Policlinico Universitario Agostino Gemelli IRCCS
Lead Sponsor
A
AIRC (Italian Association for Cancer Research)
Collaborating Sponsor
AI-Summary
What this Trial Is About
Researchers are evaluating treatment options for patients with metastatic renal cell carcinoma (mRCC) who have shown initial benefit from anti-PD1-based immunotherapy. This Phase IV, randomized, multi-arm, multicenter clinical trial aims to determine whether treating the primary kidney tumor can improve overall survival. The study focuses on patients with clear cell histology renal cancer who continue to receive standard immune-based medical therapies without disease progression. Participants with primary kidney tumors 4 cm or smaller will be randomly assigned to one of three groups: cytoreductive nephrectomy plus standard care, radiotherapy on the primary tumor plus standard care, or standard care alone. Those with tumors larger than 4 cm will be randomized to either deferred cytoreductive nephrectomy plus standard care or standard care alone. Radiotherapy involves a single 25 Gy dose or equivalent fractions, and nephrectomy options include radical, partial, or lumpectomy. Medical therapy continues alongside these interventions using combinations such as axitinib plus pembrolizumab or nivolumab-based regimens. During the study, participants will undergo regular assessments including survival monitoring over 30 months. Researchers will evaluate overall and progression-free survival, adverse events, quality of life through EQ-5D-5L and FKSI-19 questionnaires, and surgery-related complications. Follow-up includes monitoring laboratory function and imaging to assess tumor response and safety. The entire participation period spans at least 30 months to assess the long-term effects of these treatment strategies.
CONDITIONS
Brief Title
Primary Tumor Ablation and Outcome in Metastatic Renal Cell Carcinoma Treated With Immunotherapy Combinations.
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Able and willing to sign informed consent
- Male or female aged 18 years or older
- Histological or cytological confirmation of renal cell carcinoma with mostly clear cell histology
- Evidence of primary renal cancer
- Measurable or non-measurable metastatic disease as per RECIST 1.1 criteria
- ECOG performance status of 0 or 1
- Life expectancy of at least 9 months
- Receiving anti-PD1 based therapy for mRCC for 24 to 52 weeks without disease progression
- Eligible to continue combination therapies for mRCC or nivolumab alone after nivolumab + ipilimumab
- Agree to use effective contraception during and for at least 3 months after study treatment
- Adequate bone marrow, liver, and kidney function confirmed by laboratory tests within 7 days before treatment start
You will not qualify if you...
- More than one prior treatment for metastatic or locally advanced renal cell carcinoma
- Having only one kidney
- Contraindications to surgery or radiotherapy on the primary kidney tumor
- Definitive discontinuation of mRCC therapies due to toxicity (except ipilimumab discontinuation)
- Other cancers diagnosed within 3 years except certain treated cancers
- Recent major surgery, open biopsy, or trauma within 28 days
- Pregnancy or breastfeeding
- Specific heart conditions including severe heart failure, unstable angina, recent heart attack, serious arrhythmias, uncontrolled high blood pressure, or recent blood clots
- Active infection above grade 2 severity
- Known HIV or chronic hepatitis B or C infection
- Autoimmune reactions that prevent anti-PD1 therapy use
- Seizure disorders requiring medication
- Symptomatic brain or meningeal tumors unless stable and treated
- History of organ transplant
- History or evidence of serious bleeding disorders
- Non-healing wounds, ulcers, or fractures
- Kidney failure requiring dialysis
- Any unstable illness or condition that risks patient safety or study compliance
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - Participants continue treatment as per assigned arm until disease progression or discontinuation
Participants receive one of the following: deferred cytoreductive nephrectomy surgery, radiotherapy to the primary tumor, or continuation of medical immunotherapy treatment for metastatic renal cell carcinoma.
Visits depend on treatment type, including surgery or radiotherapy visits plus ongoing medical therapy visits
Duration - Up to 30 months after treatment initiation
Participants are monitored for overall survival, progression-free survival, adverse events, and quality of life up to 30 months after treatment start.
Periodic visits for assessments during follow-up
Trial Site Locations
Total: 1 location
1
Fondazione Policlinico Universitario A. Gemelli IRCCS
Roma, Italy, 00168
Actively Recruiting
Research Team
R
Roberto Iacovelli, M.D.; Ph.D.
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
3
Similar Trials
Frequently Asked Questions
Have more questions? Get in touch with our team for quick support
Not the Right Trial for You?
Explore thousands of other clinical trials that might be a better match.
Sign up to get personalized trial recommendations delivered to your inbox.
Already have an account? Log in here