Phase 4 Kidney Cancer Trial, Recruiting
Who may be able to join
AI generated eligibility summary. Written by an AI model from the official source data and checked on a sample basis. It can contain mistakes, so confirm anything important against the original source. How we use AI
Who might be able to join this trial:
- You are willing and able to read and sign a consent form before any study procedures begin.
- You are 18 years of age or older.
- Your kidney cancer has been confirmed by a tissue or cell sample and is mainly the "clear cell" type.
- You have a primary (original) kidney tumor still present.
- Your cancer has spread to other parts of the body (metastatic disease), whether or not individual tumors can be measured by scans.
- You are generally well enough to carry out daily activities with little or no limitation (confirm with trial site).
- Your doctors expect you to live for at least 9 months.
- You have been receiving one of the following approved treatment combinations for at least 24 weeks but no more than 52 weeks, and your cancer has not gotten worse: axitinib + pembrolizumab, cabozantinib + nivolumab, lenvatinib + pembrolizumab, or nivolumab alone (after previously receiving nivolumab + ipilimumab).
- Your doctors agree you can continue your current treatment.
- You agree to use reliable contraception from the time you sign consent until at least 3 months after your last study treatment, if there is any chance you could become pregnant or father a child.
- Your blood tests taken within 7 days before starting the study show your kidneys, liver, and bone marrow are working well enough, including acceptable levels of creatinine, bilirubin, liver enzymes, blood clotting measures, platelets, hemoglobin, and white blood cells (confirm specific values with trial site).
Who may not be able to join:
- You have received more than one type of treatment for advanced or metastatic kidney cancer.
- You have only one kidney.
- There is a medical reason you cannot have surgery or radiotherapy on your kidney tumor.
- You had to permanently stop one of your current cancer treatments because of side effects (note: stopping ipilimumab from the nivolumab + ipilimumab combination is an exception).
- You have been diagnosed with another cancer in the past 3 years, unless it was certain early-stage or cured cancers such as cervical cancer in situ, common skin cancers, early prostate cancer with very low markers, or early bladder cancer (confirm with trial site).
- You had a major surgery, open biopsy, or serious injury within 28 days before signing the consent form.
- You are currently pregnant or breastfeeding, or a pregnancy test done within 7 days before treatment comes back positive.
- You have certain heart conditions, including severe heart failure, unstable or recent chest pain, a heart attack within the last 6 months, heart rhythm problems requiring certain medications, or blood pressure that is not well controlled.
- You have an active infection that is more than mildly severe (confirm with trial site).
- You have a known history of HIV, or chronic hepatitis B or C.
- You have an autoimmune condition or side effect that means you cannot safely take anti-PD1 therapy (the type of immunotherapy used in this trial).
- You have a seizure disorder that requires ongoing medication.
- You have brain or spinal fluid metastases that are currently causing symptoms, unless specific conditions about your stability and treatment history are met (confirm with trial site).
- You have previously received an organ transplant.
- You have a history of serious bleeding problems, or have had a significant bleeding event within the last 4 weeks.
- You have a wound, ulcer, or bone fracture that is not healing.
- Your kidneys have failed and you require dialysis.
- You have any other unstable illness or medical condition that could put your safety at risk during the trial.
Important: Always verify eligibility with the trial site directly before applying.
Based on publicly available eligibility criteria from ClinicalTrials.gov. Verify directly with the trial site before acting. This is not medical advice.
Contact this trial
Principal Investigator: Roberto Iacovelli, M.D.; Ph.D., Catholic University of Rome, Italy
Phone: +390630157373
Contact details sourced from ClinicalTrials.gov. Verify directly with the trial site before attending.
GP referral letter
Print a one-page summary to share with your doctor.
Trial details
Where this trial is recruiting
Primary endpoints
30-months Overall Survival for surgery vs. control
Can't join this trial?
Data last synced from ClinicalTrials.gov: 20 July 2026. Trial status can change. Always verify current status directly with the trial site before making any decision.