TDM for Optimized Outcome in Patients With mRCC.

NCT04659343 | Recruiting

• 1 other identifier: TDM mRCC
• Study Type: observational
• Target: 200
• Locations: 1 country
• Sites: 1

Brief 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

Outcome Measures

Primary Outcomes (3)

• Overall survival (OS)

  Calculated from the date of inclusion, to the date of death of any cause or censored at the date at last follow-up.

  12 months follow-up for each patient.

• Progression free survival (PFS)

  According to the RECIST v1.1

  12 months follow-up for each patient.

• Quality of life according to NCCN-FACT FKSI-19.

  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.

  12 months follow-up for each patient.

Secondary Outcomes (5)

• Amount of antidrug antibodies (ADAs) developed.

  12 months follow-up for each patient.

• SNP-genotype of PD-1 and CTLA-4 receptors reported as proportion of patients with pp-, pq- and qq-genotype respectively.

  12 months follow-up for each patient.

• In pts treated with pazopanib: UGT1A1 genetic polymorphism

  At baseline

• Fecal swap

  12 months follow-up for each patient

• Measuring CT DNA in patiets receiving nivolumab and ipilimumab

  12 months follow-up for each patient

Study Arms (1)

Cohort 1

Patients treated for metastatic renal cell carcinoma in Denmark over a 6-year period.

Other: Measurement of concentration of active metabolite in cancer treatment.

Interventions

Measurement of concentration of active metabolite in cancer treatment. OTHER

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

Also known as: Measurement of autoantibodies and receptor polymorfia for CTLA-4 and PD-1 inhibition.

Cohort 1

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

Adult patients in Denmark with medically treated metastatic renal cell carcinoma. Patients are treated in the two biggest oncology departments in Denmark, Aarhus and Herlev.

You may qualify if:

• Patients in Denmark with medically treated metastatic renal cell carcinoma.

You may not qualify if:

• No written informed consent.

Sponsors & Collaborators

• Niels Fristrup: lead
• Herlev Hospital: collaborator
• Rigshospitalet, Denmark: collaborator

Study Sites (1)

Department of Oncology, Aarhus University Hospital

Aarhus, Danmark, 8200, Denmark

RECRUITING

Related Publications (1)

• Henriksen JN, Andersen CU, Donskov F, Hoffmann-Lucke E, Greibe E, Fristrup N. Therapeutic drug monitoring (TDM) of tyrosine kinase inhibitors (TKI) for optimized outcome in patients with metastatic renal cell carcinoma. The TKI-TDM Trial. Study protocol. Acta Oncol. 2025 Jun 2;64:729-733. doi: 10.2340/1651-226X.2025.43693.

  PMID: 40457584 DERIVED

Biospecimen

Retention: SAMPLES WITH DNA

Whole blood samples

MeSH Terms

Conditions

Kidney Neoplasms; Drug-Related Side Effects and Adverse Reactions

Interventions

CTLA-4 Antigen

Condition Hierarchy (Ancestors)

Urologic Neoplasms; Urogenital Neoplasms; Neoplasms by Site; Neoplasms; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Kidney Diseases; Urologic Diseases; Male Urogenital Diseases; Chemically-Induced Disorders

Intervention Hierarchy (Ancestors)

Immune Checkpoint Proteins; Proteins; Amino Acids, Peptides, and Proteins; Costimulatory and Inhibitory T-Cell Receptors; Receptors, Immunologic; Receptors, Cell Surface; Membrane Proteins; Antigens, Differentiation, T-Lymphocyte; Antigens, Differentiation; Antigens, Surface; Antigens; Biological Factors; Biomarkers

Study Officials

• Niels Fristrup, MD, PhD

  University of Aarhus

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Niels Fristrup, MD, PhD

CONTACT

+4520914161; niels.fristrup@rm.dk

Jakob N Henriksen, MD

CONTACT

+4540438804; jakob.n.henriksen@oncology.au.dk

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: MD PhD

Study Record Dates

• First Submitted: November 20, 2020
• First Posted: December 9, 2020
• Study Start: November 1, 2020
• Primary Completion (Estimated): August 31, 2028
• Study Completion (Estimated): August 31, 2029
• Last Updated: May 4, 2026

Record last verified: 2026-04

Data Sharing

• IPD Sharing: Will not share

Locations

DK (1)