Phase 2 Kidney Cancer Trial, Recruiting NCT05663710 Sponsor: M.D. Anderson Cancer Center Condition: Kidney Cancer
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Phase 2 Kidney Cancer Trial, Recruiting

NCT05663710
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 are 18 years of age or older
  • You have been diagnosed with kidney cancer (renal cell carcinoma) that is mostly of the "clear cell" type and has either spread to nearby tissues or to other parts of the body
  • You have at least one tumor that can be measured on a scan, according to standard measurement guidelines
  • You are generally well enough to carry out light activity or desk work — not confined to bed (this is measured on a standard 0–1 scale used by doctors)
  • Your blood counts, kidney function, and liver function meet minimum levels set by the trial (confirm with trial site for exact values)
  • If you are a woman who could become pregnant, you have had a negative pregnancy blood test within 7 days before starting the study drug
  • If you could become pregnant, or are a man whose partner could become pregnant, you agree to use a highly effective form of contraception during the study and for 120 days after stopping the study drug (options include abstinence, sterilization, hormonal contraception, or an intrauterine device)
  • You are able to swallow tablets or capsules
  • You are able to provide a tumor tissue sample, either from a previous biopsy or a new one
  • If you have cancer that has spread to the brain, you may still be eligible as long as other measurable tumors exist elsewhere, the brain tumors have been stable for at least one month without needing treatment, and they are not life-threatening

Who may not be able to join:

  • You have already received any systemic treatment (such as drug therapy) for kidney cancer that has spread to other parts of the body
  • You have a history of cancer spreading to the lining around the brain or spinal cord, or have had spinal cord compression
  • You have a history of an autoimmune disease that still requires active treatment
  • You have brain tumors that have not been treated, or treated ones that are still progressing, bleeding, or require ongoing steroid (dexamethasone) or anti-seizure medication
  • You have had radiation therapy to your bones within the past 2 weeks, or radiation to any other area lasting 5 or more days within the past 4 weeks, or have ongoing serious side effects from past radiation
  • Your blood pressure is consistently above 140/90, even with blood pressure medication
  • You have had a major heart or blood vessel event in the past 6 months, such as a heart attack, stroke, serious heart rhythm problem, blood clot in the lungs, or severe heart failure
  • You have another significant heart, lung, mental health, or other medical condition that the doctor feels could interfere with the study (confirm with trial site)
  • You currently have an active infection that requires treatment with medication
  • You are currently taking part in another clinical trial that involves a treatment
  • You are regularly taking certain medications that strongly affect how the liver processes drugs (known as strong CYP3A4 inducers or inhibitors — confirm with trial site)
  • You have a condition that prevents your body from properly absorbing food or medication due to past bowel surgery or a digestive disease
  • You have certain serious digestive problems, such as active stomach ulcers, inflammatory bowel disease, or recent bowel perforation, fistula, or blockage within the past 6 months (confirm with trial site for full list)
  • Your tumor is growing into or wrapping around a major blood vessel
  • You have other significant health problems such as a serious non-healing wound, moderate to severe liver disease, need for dialysis, or a history of receiving an organ transplant
  • You have had major surgery within the past 2 months, or have not fully healed from any surgery, or have ongoing complications from a past surgery
  • You have or have had another type of cancer (other than kidney cancer), unless it was a minor skin cancer or another cancer from which you have been fully free of disease for more than 2 years

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 16 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: Eric Jonasch, MD, M.D. Anderson Cancer Center

Phone: (713) 563-7232

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
Registry
ClinicalTrials.gov
Start date
30 June 2023
Est. completion
30 October 2027

Where this trial is recruiting

🇺🇸 United States

Primary endpoints

Incidence of Adverse Events, Graded According to National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) Version (v) 5.0

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: 16 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