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TDM for Optimized Outcome in Patients With mRCC.

NCT04659343 · Status: RECRUITING · Type: OBSERVATIONAL · Enrollment: 200

Last updated 2026-05-04

No results posted yet for this study

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.

Conditions

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

Interventions

OTHER

Measurement 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.

Sponsors & Collaborators

  • Herlev Hospital

    collaborator OTHER

  • Rigshospitalet, Denmark

    collaborator OTHER

  • Niels Fristrup

    lead OTHER

Principal Investigators

  • Niels Fristrup, MD, PhD · University of Aarhus

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2020-11-01
Primary Completion
2028-08-31
Completion
2029-08-31

Countries

  • Denmark

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04659343 on ClinicalTrials.gov