Phase 2 Kidney Cancer Trial, Recruiting NCT05756569 Sponsor: Emory University Condition: Kidney Cancer
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Phase 2 Kidney Cancer Trial, Recruiting

NCT05756569
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:

  • Adults aged 18 or older, of any gender
  • People whose cancer has spread to other parts of the body or cannot be surgically removed
  • People diagnosed with a specific type of bladder cancer classed as a "variant histology" (such as nested, micropapillary, plasmacytoid, sarcomatoid, or similar subtypes) or a non-urothelial bladder cancer of epithelial origin (such as squamous cell carcinoma or adenocarcinoma), including cancers arising from related nearby structures such as the ureter, urethra, or renal pelvis — mixed tumour types may also be eligible if more than half of the tumour is one of these subtypes (confirm with trial site)
  • People who have received any number of previous cancer treatments, or none at all
  • People who are well enough to carry out normal daily activities, or who have only minor limitations (assessed using a standard medical scale called ECOG, score 0 or 1)
  • People who have measurable tumour(s) visible on a CT or MRI scan meeting specific size requirements
  • People with adequate organ and bone marrow function, based on tests done within 28 days before starting treatment
  • People who have a tumour tissue sample available, or who are willing to have a biopsy taken before treatment starts
  • People with a life expectancy of more than 12 weeks, as judged by the treating doctor
  • Women of childbearing potential who have a negative pregnancy test before starting treatment
  • People (and their partners) who agree to use reliable contraception during the trial and for 6 months after the last dose, and who agree not to donate eggs or sperm during this period
  • People who have finished all previous cancer treatments (including surgery, radiotherapy, chemotherapy, immunotherapy, or experimental treatments) at least 4 weeks before starting the trial
  • People who are willing and able to follow the trial schedule, attend visits, take medications as directed, and complete required tests
  • People who have been fully informed about the trial and have given their written consent to participate

Who may not be able to join:

  • People whose bladder cancer is of a neuroendocrine type (such as small cell or large cell carcinoma) or a non-epithelial type (such as sarcoma, melanoma, paraganglioma, or primary lymphoma of the bladder)
  • People who have had chemotherapy or radiotherapy within the 4 weeks before joining, or who are still experiencing significant side effects (grade 2 or higher, except hair loss) from previous treatment
  • People currently taking part in another clinical trial or using another experimental treatment within 21 days before the first dose
  • People with a known allergy to medications that are chemically or biologically similar to the drugs used in this trial
  • People with ongoing nerve damage affecting sensation or movement, rated at a moderate or severe level (grade 2 or higher)
  • People who have previously been treated with the specific drugs used in this trial (EV or a PD-1/PD-L1 checkpoint inhibitor), including as maintenance therapy
  • People with poorly controlled diabetes (confirm specific blood sugar thresholds with trial site)
  • People with active cancer that has spread to the brain or spinal cord
  • People who have had another active cancer in the past 24 months, with some exceptions such as certain skin cancers or localised prostate cancer (confirm with trial site)
  • People currently receiving systemic antibiotic or antifungal treatment for an active infection, or taking high-dose steroid medications
  • Women of childbearing potential with a positive pregnancy test at the start of the trial
  • Women who are currently breastfeeding
  • People with an autoimmune disease that has required systemic medical treatment in the past 2 years, or with active hepatitis B, active hepatitis C, or active tuberculosis
  • People with a history of active eye conditions involving the cornea, such as keratitis or corneal ulcers
  • People who have received an organ or tissue transplant from another person
  • People with serious heart conditions, including severe heart failure, unstable chest pain, or significant heart rhythm problems occurring within the past 6 months
  • People with other serious uncontrolled medical or psychiatric conditions that could affect their ability to participate safely in 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 28 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: Jacqueline Brown, MD, Emory University Hospital/Winship Cancer Institute

Phone: 404-778-1900

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
26 September 2023
Est. completion
16 December 2026

Where this trial is recruiting

🇺🇸 United States

Primary endpoints

Overall response rate

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: 28 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