RecruitingNCT04659343

TDM for Optimized Outcome in Patients With mRCC.

Therapeutic Drug Monitoring for Optimized Outcome in Patients With Metastatic Renal Cell Carcinoma

Sponsor

Niels Fristrup

Enrollment

200 participants

Start Date

Nov 1, 2020

Study Type

OBSERVATIONAL

Conditions

Renal Cell Carcinoma Metastatic Kidney Cancer Drug Toxicity Drug Side Effect Drug Mechanism

Summary

The purpose of this observational study is to assess the role of plasma concentration monitoring of treatment drugs for patients with metastatic renal cell carcinoma (mRCC) in terms of efficacy and side effects. It furthermore holds microbiome characterization of CPI-treated patients. Furthermore, the investigators examines the role of anti-drug antibodies and receptor polymorphisms in CTLA-4 and PD-1 receptors in treatment failure among patients with mRCC treated with check point immunotherapy (CPI). Moreover, polymorphisms in the UGT1A1 gene will be correlated with the pazopanib treatment dose.

Eligibility

Min Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This observational study in Denmark uses therapeutic drug monitoring (TDM) — measuring drug levels in the blood — to personalize treatment for patients with metastatic kidney cancer (metastatic renal cell carcinoma) who are taking targeted therapy. The aim is to see whether adjusting doses based on drug levels improves outcomes. **You may be eligible if...** - You are a patient in Denmark with metastatic kidney cancer being treated with systemic medications **You may NOT be eligible if...** - You have not given written informed consent Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

OTHERMeasurement of concentration of active metabolite in cancer treatment.

Medical treatment for metastatic renal cell carcinoma with axitinib, cabozantinib, pazopanib, sorafenib, sunitinib, tivozanib and ipilimumab and nivolumab.

Locations(1)

Department of Oncology, Aarhus University Hospital

Aarhus, Danmark, Denmark

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NCT04659343

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