Phase 2 Kidney Cancer Trial, Recruiting NCT07087860 Sponsor: Mayo Clinic Condition: Kidney Cancer
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Phase 2 Kidney Cancer Trial, Recruiting

NCT07087860
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 18 years of age or older
  • For Groups A and B: You have been diagnosed with bladder cancer or upper urinary tract cancer (confirmed by a tissue biopsy), and your cancer has gotten worse despite treatment with the drugs enfortumab vedotin and pembrolizumab (these treatments do not need to have been given at the same time or right before joining)
  • For Group C: You have been diagnosed with bladder cancer or upper urinary tract cancer (confirmed by a tissue biopsy), your cancer has gotten worse after a type of targeted drug treatment called an ADC, and you do not qualify for Groups A or B (patients from Groups A and B whose cancer progressed on that treatment may also be eligible for this group after re-enrolling)
  • Your cancer must be measurable on scans, according to a standard set of measurement rules
  • You must be reasonably active and able to care for yourself, based on a standard doctor's assessment (scores 0, 1, or 2 on a common medical scale)
  • Your blood counts and organ function (blood, liver, and kidney) must meet certain minimum levels, checked within the past 30 days
  • If you are capable of becoming pregnant, you must have a negative pregnancy test within 8 days before joining
  • You must be willing and able to sign a consent form agreeing to take part
  • You must be able to complete questionnaires, either on your own or with help
  • You must be willing to receive whichever treatment is assigned to your group
  • You must be willing to provide blood, fluid, and tissue samples for research purposes
  • You must be willing to return to the trial site for follow-up visits during the study

Who may not be able to join:

  • People who are currently pregnant
  • People who are currently breastfeeding
  • People who are capable of becoming pregnant or fathering a child and are not willing to use reliable contraception during the trial, because the effects of the study drug on an unborn baby or newborn are not yet known
  • People whose cancer has certain specific features under the microscope (neuroendocrine features or signet ring cell features), even in small amounts
  • People who have had another active cancer in the past 24 months — with some exceptions, including: skin cancers considered fully cured, non-invasive cervical cancer considered fully cured, certain very low-risk breast conditions, or certain low-risk prostate cancers that have been treated or are being closely monitored
  • People who have had serious heart or blood vessel problems in the past 6 months, such as severe heart failure, unstable chest pain, a heart attack, certain dangerous heart rhythm problems, a stroke, or a mini-stroke
  • People with mental health or personal circumstances (such as substance use) that might make it difficult to follow the trial requirements
  • People for whom the trial doctor believes participation would not be in their best interest or could interfere with how the trial is assessed (confirm with trial site)

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: Jacob J. Orme, MD, PhD, Mayo Clinic

Phone: 855-776-0015

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
Registry
ClinicalTrials.gov
Start date
1 August 2025
Est. completion
7 August 2028

Where this trial is recruiting

🇺🇸 United States

Primary endpoints

Overall response rate (ORR) (Groups A and B); ORR (Cohort C)

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