Kidney Cancer Trial, Recruiting NCT05753839 Sponsor: Yonsei University Condition: Kidney Cancer
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Kidney Cancer Trial, Recruiting

NCT05753839
Recruiting Not Applicable

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:

  • People who have been diagnosed with metastatic kidney cancer (specifically the clear cell type), confirmed by a core needle biopsy.
  • People whose cancer has spread to other parts of the body while the original tumour is still present in the kidney.
  • People who are willing to provide biological samples (such as tissue or blood) for research.
  • People aged 19 or older.
  • People who have signed an informed consent form before any study procedures begin.
  • People who are willing and able to follow the study requirements.
  • People who have measurable tumours that can be tracked using standard imaging guidelines.
  • People with a life expectancy of more than 4 months.
  • People whose cancer is classified as intermediate- or poor-risk based on an international kidney cancer scoring system (IMDC criteria).
  • People for whom the combination treatment nivolumab/ipilimumab has been recommended by national health authorities as a standard treatment option.
  • People with a reasonably good level of physical functioning, as measured by a standard performance scale (Karnofsky score of 70 or above).
  • Women who are not pregnant (confirmed by a blood test) and not breastfeeding, unless pregnancy is not possible due to menopause, removal of the uterus, or removal of the ovaries.
  • Women who could become pregnant and men who are able to father children must be using reliable contraception during the study.
  • People whose blood test results meet the required levels for bone marrow function, blood clotting, liver function, and kidney function (confirm with trial site for specific values).

Who may not be able to join:

  • People who have already received systemic (whole-body) treatment for their metastatic kidney cancer.
  • People who have had major surgery, an open surgical biopsy, or a serious injury within 28 days before enrolling.
  • People who have had another cancer within the past 5 years.
  • People with significant or active heart or blood vessel problems, such as a stroke or heart attack within the past 6 months, unstable chest pain, or moderate-to-severe heart failure.
  • People with brain metastases that require high-dose steroid medication to manage symptoms.
  • People who have taken part in another clinical trial or received an experimental treatment within the past 30 days.
  • People with an active autoimmune disease or a condition that requires ongoing steroid or immune-suppressing medication (some exceptions apply — confirm with trial site).
  • People who have taken oral or intravenous antibiotics within the 14 days before starting treatment.
  • People who test positive for hepatitis B or hepatitis C, indicating an active or chronic infection.
  • People with a known allergy to monoclonal antibody medications.
  • People with a known positive HIV test result or a diagnosis of AIDS.
  • People who are not willing to provide biological samples for the study.
  • People who are not willing or able to follow the study protocol.
  • Children, prisoners, pregnant women, people with cognitive or mental disabilities, or people who may be in a vulnerable situation due to economic or educational disadvantage.
  • People who are unable to read and understand the consent form.

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 19 July 2026
This study is not part of the standard drug-approval phase pathway (for example an observational, device, behavioural, or registry study), so a phase success rate does not apply.

Contact this trial

Principal Investigator: Won Sik Ham, Department of Urology and Urological Science Institute, Yonsei University College of Medicine

Phone: 02-2228-2310

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
Not Applicable
Registry
ClinicalTrials.gov
Start date
1 July 2023
Est. completion
27 December 2027

Where this trial is recruiting

🇰🇷 South Korea

Primary endpoints

Overall survival

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: 19 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