TDM for Optimized Outcome in Patients With mRCC.
Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18+
SponsorNiels Fristrup
About this trial
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 criteria
This trial does not accept healthy volunteersQualifiers
Patients in Denmark with medically treated metastatic renal cell carcinoma.
Disqualifiers
No written informed consent.
Trial 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.
Trial design
Design model
Cohort
Time perspective
Prospective
Treatments tested in this trial
Measurement of concentration of active metabolite in cancer treatment.
Other interventionMedical treatment for metastatic renal cell carcinoma with axitinib, cabozantinib, pazopanib, sorafenib, sunitinib, tivozanib and ipilimumab and nivolumab.
Treatment groups
200 Participants
are divided into 1 treatment groupGroup A: Cohort 11 intervention
Trial outcomes
Primary outcomes
1
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.
Time frame
12 months follow-up for each patient.2
Progression free survival (PFS)
According to the RECIST v1.1
Time frame
12 months follow-up for each patient.3
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.
Time frame
12 months follow-up for each patient.Secondary outcomes
1
Amount of antidrug antibodies (ADAs) developed.
In patients treated with ipilimumab/nivolumab
Time frame
12 months follow-up for each patient.2
SNP-genotype of PD-1 and CTLA-4 receptors reported as proportion of patients with pp-, pq- and qq-genotype respectively.
In pts treated with ipilimumab/nivolumab
Time frame
12 months follow-up for each patient.3
In pts treated with pazopanib: UGT1A1 genetic polymorphism
TA6/TA6, TA6/TA7 or TA7/TA7
Time frame
At baseline4
Fecal swap
Measuring the microbiome composition, from start and during CPI therapy
Time frame
12 months follow-up for each patientSponsors and contacts
Click on the lead sponsor to view all of their trials.
Niels Fristrup
Lead sponsor
Aarhus University Hospital
Sponsor institution
Herlev Hospital
Collaborator
Rigshospitalet, Denmark
Collaborator
Source ClinicalTrials.gov