TDM for Optimized Outcome in Patients With mRCC.

Condition(s) studied

Investigational drug(s) / intervention(s)

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.

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.

Eligibility

Primary outcome measure(s)

• Overall survival (OS) — 12 months follow-up for each patient.
  Calculated from the date of inclusion, to the date of death of any cause or censored at the date at last follow-up.
• Progression free survival (PFS) — 12 months follow-up for each patient.
  According to the RECIST v1.1
• Quality of life according to NCCN-FACT FKSI-19. — 12 months follow-up for each patient.
  National Comprehensive Cancer Network/ Functional Assessment of Cancer Therapy (FACT)-Kidney Symptom Index 19 (NCCN-FACT FKSI-19). 19 items, each item scored on a 5 point Likert-scale, covering cancer quality of life.

Trial sites (1)

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