Phase 2 Kidney Cancer Trial, Recruiting NCT05361720 Sponsor: Vanderbilt-Ingram Cancer Center Condition: Kidney Cancer
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Phase 2 Kidney Cancer Trial, Recruiting

NCT05361720
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 have been diagnosed with kidney cancer (renal cell carcinoma) that contains a specific type of cancer cell called "clear cell"
  • Your cancer is advanced (cannot be cured with surgery or radiation) or has spread to other parts of the body (stage IV)
  • You are able to understand and sign a consent form agreeing to take part in the study
  • You are 18 years of age or older
  • You are reasonably active and able to care for yourself — measured by a standard health performance scale (confirm with trial site)
  • You have never received any systemic drug treatment (such as chemotherapy, immunotherapy, or targeted therapy) for your kidney cancer at any stage
  • You have at least one tumor that can be measured using standard imaging scans
  • You are able to provide a tumor tissue sample for genetic testing, and based on the results of that test, your cancer falls into a specific group (Cluster 1/2 or 4/5) — if your results place you in a different group (Cluster 3/6/7), you would not be eligible
  • Your kidneys are working well enough, based on a blood test measuring kidney function
  • Your liver is working well enough, based on blood tests measuring liver enzymes and bilirubin levels
  • If you are a woman who could become pregnant, you must have a negative pregnancy test before starting treatment

Who may not be able to join:

  • You had major surgery requiring general anesthesia within the 14 days before starting treatment
  • Your blood pressure is not well controlled (above 160/90 mmHg), even with blood pressure medication
  • You currently have an active infection that requires treatment given through a drip (IV infusion)
  • You have an existing abnormal opening (fistula) in your digestive system or elsewhere in your body
  • You have a high level of protein in your urine (above a certain threshold measured over 24 hours)
  • You have wounds that are not healing properly (this applies only to patients assigned to a specific treatment combination — confirm with trial site)
  • You have significant active bleeding, including coughing up blood
  • You are unable to swallow tablets or pills, or you have a poorly controlled digestive condition (such as Crohn's disease, ulcerative colitis, ongoing diarrhea, or bowel obstruction) that could affect how your body absorbs oral medication (this applies only to patients assigned to a specific treatment combination — confirm with trial site)
  • You have serious heart disease, such as severe heart failure, unstable chest pain (angina) within the past 3 months, or a heart attack within the past 3 months
  • You have cancer that has spread to the brain, unless you have already completed treatment for it (such as radiation or surgery)
  • You are currently taking high-dose steroid medications (above a low daily threshold) or other medications that suppress the immune system, within 14 days before starting the trial
  • You have an active autoimmune disease requiring systemic treatment (confirm with trial site for details on steroid exceptions)

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 I Rini, MD, Vanderbilt University/Ingram Cancer Center

Phone: 800-811-8480

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
Vanderbilt-Ingram Cancer Center
Registry
ClinicalTrials.gov
Start date
6 December 2022
Est. completion
1 October 2026

Where this trial is recruiting

🇺🇸 United States

Primary endpoints

Overall response rate (ORR) (Arm 1); Overall response rate (Arm 2)

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