Kidney Cancer Clinical Trial
Official title:
Therapeutic Drug Monitoring for Optimized Outcome in Patients With Metastatic Renal Cell Carcinoma
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. 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. Moreover, polymorphisms in the UGT1A1 gene will be correlated with the pazopanib treatment dose.
Status | Recruiting |
Enrollment | 200 |
Est. completion date | May 1, 2027 |
Est. primary completion date | November 1, 2026 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years and older |
Eligibility | Inclusion Criteria: - Patients in Denmark with medically treated metastatic renal cell carcinoma. Exclusion Criteria: - No written informed consent. |
Country | Name | City | State |
---|---|---|---|
Denmark | Department of Oncology, Aarhus University Hospital | Aarhus | Danmark |
Denmark | Department of Oncology, Herlev Hospital | Herlev |
Lead Sponsor | Collaborator |
---|---|
Aarhus University Hospital | Herlev Hospital, Rigshospitalet, Denmark |
Denmark,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | 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. | 6 months follow-up for each patient. | |
Primary | Progression free survival (PFS) | According to the RECIST v1.1 | 6 months follow-up for each patient. | |
Primary | 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. |
6 months follow-up for each patient. | |
Secondary | Amount of antidrug antibodies (ADAs) developed. | In patients treated with ipilimumab/nivolumab | 6 months follow-up for each patient. | |
Secondary | 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 | 6 months follow-up for each patient. | |
Secondary | In pts treated with pazopanib: UGT1A1 genetic polymorphism | TA6/TA6, TA6/TA7 or TA7/TA7 | At baseline |
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