Phase 4 Kidney Cancer Trial, Recruiting NCT06903312 Sponsor: Fondazione Policlinico Universitario Agostino Gemelli IRCCS Condition: Kidney Cancer
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Phase 4 Kidney Cancer Trial, Recruiting

NCT06903312
Recruiting Phase 4

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.

This is a simplified plain English summary of the eligibility criteria. Full criteria are set by the trial investigators and may include additional requirements not shown here. Never self-exclude from a trial based on this summary. Contact the trial site directly to confirm your eligibility.
Last synced 20 July 2026
Phase 4 trials study a drug that has already been approved, monitoring long-term safety and effectiveness in real-world use.

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

Status
Recruiting
Phase
Phase 4
Registry
ClinicalTrials.gov
Start date
15 June 2025
Est. completion
1 October 2027

Where this trial is recruiting

🇮🇹 Italy

Primary endpoints

30-months Overall Survival for surgery vs. control

Can't join this trial?

Expanded access pathways

If this trial is not available to you, other access pathways may exist. In Australia, the TGA Special Access Scheme allows access to unapproved therapeutic goods for individual patients.

TGA Special Access Scheme information

Find other recruiting trials on ClinicalTrials.gov

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.

Trial recruitment status can change without notice between our nightly data updates. Always contact the trial site directly to confirm current recruitment status before making any decisions or travel arrangements.

View original record on ClinicalTrials.gov