Phase 2 Kidney Cancer Trial, Recruiting NCT07188896 Sponsor: Brian Rini Condition: Kidney Cancer
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Phase 2 Kidney Cancer Trial, Recruiting

NCT07188896
Recruiting Phase 2

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 must be at least 18 years old at the time you give your consent to participate.
  • You must be well enough to carry out most daily activities (your doctor will assess this using a standard health scale within 2 weeks before signing up).
  • Your kidney cancer must have been confirmed by a lab test and must include a specific type called "clear cell" kidney cancer.
  • Your cancer must be advanced (cannot be cured by surgery or radiation) or has spread to other parts of the body (Stage IV).
  • You must not have received any previous drug treatments (such as chemotherapy, immunotherapy, or targeted therapy) for your kidney cancer, including treatments given before or after surgery.
  • You must have at least one area of cancer that can be measured on a scan, checked within 28 days before signing up.
  • You must be able to provide a stored tissue sample from your tumor (either from the spread of the cancer or from the original kidney tumor), taken ideally within the last 3 months but no more than 12 months ago.
  • Your liver, kidneys, and other organs must be working well enough, confirmed by blood tests within 2 weeks before signing up.
  • If you are a woman who could become pregnant, you must have a negative pregnancy test within 2 weeks before signing up.
  • If you could become pregnant or could cause a pregnancy, you must agree to either avoid sexual intercourse or use reliable birth control during the study.
  • If you have HIV, you must be on effective treatment with an undetectable viral load and a healthy immune cell count within the last 6 months.
  • If you have a chronic hepatitis B infection, your virus levels must be undetectable and you must be on the appropriate treatment if needed.
  • If you have had hepatitis C in the past, it must have been successfully treated and cleared from your body; if you are currently being treated for hepatitis C, your virus levels must be undetectable.
  • You must be able to understand and follow all study procedures for the full length of the trial, as judged by your doctor.

Who may not be able to join:

  • You have previously received any drug treatment for your kidney cancer, whether before surgery, after surgery, or for cancer that has spread.
  • You are currently taking a steroid medication (such as prednisone) at a dose of 10 mg or more per day on an ongoing basis.
  • You have a history of a condition called myocarditis (inflammation of the heart muscle).
  • You currently have or have had within the last 2 years an autoimmune disease (where your immune system attacks your own body) that required treatment with immune-suppressing drugs — though some mild conditions such as vitiligo, resolved childhood asthma, thyroid hormone replacement, or mild psoriasis may be allowed (confirm with trial site).
  • Your cancer has spread to your brain or spinal cord (confirm with trial site for specific details).
  • You currently have an active infection that requires treatment with medication.
  • You are pregnant or breastfeeding.
  • You have or have had another type of cancer that could affect how safe or effective this trial's treatment is, as decided by your doctor.
  • You have received a live vaccine within 4 weeks before starting the trial, or you plan to receive one during the study (non-live/inactivated vaccines are generally allowed).
  • You have a known allergy or sensitivity to any of the drugs used in this trial.
  • You are currently taking part in another clinical trial, or you have taken an experimental drug or used an experimental device within 30 days of your first dose in this study.

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 26 July 2026
Phase 2: approximately ~30% of drugs entering this phase reach regulatory approval, based on published industry-wide historical data. This is not specific to this trial.
Phase success rates shown are historical industry-wide averages based on published data. They are not a prediction for this specific trial or your individual situation.

Contact this trial

Principal Investigator: Brian Rini, MD, Vanderbilt-Ingram Cancer Center

Phone: 615-936-8422

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 2
Sponsor
Brian Rini
Registry
ClinicalTrials.gov
Start date
29 April 2026
Est. completion
30 November 2029

Where this trial is recruiting

🇺🇸 United States

Primary endpoints

Objective Response Rate (ORR)

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: 26 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