Real World Evidence of Tivozanib as First-line Treatment for Metastatic Clear Cell Renal Cell Carcinoma

Spanish Oncology Genito-Urinary Group200 enrolled

Overview

The SOGUG-TIVOREAL study is a retrospective observational study with medications. This study is based on the retrospective collection of data from patients who have been treated with Tivozanib as first-line therapy between 03/01/2019 and 08/31/2024 for metastatic renal cell carcinoma (mRCC).

Study Type

OBSERVATIONAL

Enrollment

200

Conditions

Renal Cell Cancer Metastatic

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

Inclusion Criteria: 1. \- Patients ≥ 18 years old. 2. \- Who have signed the informed consent form, except for patients who were deceased at the time of inclusion. 3. \- Histological diagnosis of stage IV clear cell renal carcinoma. 4. \- Who started treatment with Tivozanib as first-line therapy between March 1, 2019, and August 31, 2024. 5. \- Who received treatment at the participating center. Exclusion Criteria: 1. \- Patients previously treated at another center who were later referred to one of the participating centers. In this case, the patient will be included in the center where the treatment was initiated. 2. \- Explicit objection by the subject or their legal representative to participate in the study.

Locations (14)

Hospital Reina Sofia

Córdoba, Andalusia, Spain

Hospital Virgen de la Victoria

Málaga, Andalusia, Spain

Hospital Virgen del Rocio

Seville, Andalusia, Spain

Outcomes

Primary Outcomes

Progression-free survival (PFS)

To evaluate the progression-free survival (PFS) in patients with metastatic clear cell renal cell carcinoma (mRCC) from the favorable risk group according to IMDC, treated with Tivozanib monotherapy as first-line therapy. The probability of progression-free survival will be described using the Kaplan-Meier method, along with the 95% confidence intervals of the point estimates, as well as the median time of survival from the start of treatment with Tivozanib until tumor progression or death from any cause, whichever occurs first. RECIST 1.1

Time frame: Day 1

Secondary Outcomes

Overall survival (OS) in favorable risk group

To evaluate the overall survival (OS) of patients with metastatic clear cell renal cell carcinoma (mRCC) from the favorable risk group according to IMDC, treated with Tivozanib monotherapy as first-line therapy. The probability of overall survival will be described using the Kaplan-Meier method, along with the 95% confidence intervals of the point estimates, as well as the median survival time from the start of treatment with Tivozanib until death from any cause. RECIST 1.1

Time frame: Day 1

Objective response rate (ORR) in favorable risk group

To evaluate the objective response rate (ORR) in patients with metastatic clear cell renal cell carcinoma (mRCC) from the favorable risk group according to IMDC, treated with Tivozanib monotherapy as first-line therapy. ORR is defined as the percentage of patients with tumor size reduction (PR) and/or disappearance (CR) after treatment. RECIST 1.1

Time frame: Day 1

Percentage of patients with PR and CR in favorable risk group

To evaluate the percentage of patients with partial response (PR) and complete response (CR) among those with metastatic clear cell renal cell carcinoma (mRCC) from the favorable risk group according to IMDC, treated with Tivozanib monotherapy as first-line therapy. RECIST 1.1

Time frame: Day 1

Data from ClinicalTrials.gov

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Hospital de Burgos

Burgos, Castille and León, Spain

Hospital de Leon

León, Castille and León, Spain

Hospital Vall de Hebron

Barcelona, Catalonia, Spain

Institut Català d'Oncologia (ICO) de L'Hospitalet de Llobregat

L'Hospitalet de Llobregat, Catalonia, Spain

Hospital Parc Tauli

Sabadell, Catalonia, Spain

Hospital Lucus Augusti

Lugo, Galicia, Spain

Hospital Severo Ochoa

Leganés, Madrid, Spain

...and 4 more locations

Progression-free survival (PFS) - Intermediate and poor risk group

To evaluate the progression-free survival (PFS) in patients with metastatic clear cell renal cell carcinoma (mRCC) from the intermediate and poor risk groups according to IMDC, treated with Tivozanib monotherapy as first-line therapy. The probability of progression-free survival will be described using the Kaplan-Meier method, along with the 95% confidence intervals of the point estimates, as well as the median time of survival from the start of treatment with Tivozanib until tumor progression or death from any cause, whichever occurs first. RECIST 1.1

Time frame: Day 1

Overall survival (OS) - Intermediate and poor risk group

To evaluate the overall survival (OS) in patients with metastatic clear cell renal cell carcinoma (mRCC) from the intermediate and poor risk groups according to IMDC, treated with Tivozanib monotherapy as first-line therapy. The probability of overall survival will be described using the Kaplan-Meier method, along with the 95% confidence intervals of the point estimates, as well as the median survival time from the start of treatment with Tivozanib until death from any cause. RECIST 1.1

Time frame: Day 1

Objective response rate (ORR) in poor and intermediate risk group

To evaluate the objective response rate (ORR) in patients with metastatic clear cell renal cell carcinoma (mRCC) from the intermediate and poor risk groups according to IMDC, treated with Tivozanib monotherapy as first-line therapy. ORR is defined as the percentage of patients with tumor size reduction (PR) and/or disappearance (CR) after treatment. RECIST 1.1

Time frame: Day 1

Percentage of patients with PR and CR in intermediate and poor risk group

To evaluate the percentage of patients with partial response (PR) and complete response (CR) among those with metastatic clear cell renal cell carcinoma (mRCC) from the intermediate and poor risk groups according to IMDC, treated with Tivozanib monotherapy as first-line therapy. RECIST 1.1

Time frame: Day 1

Toxicity profile of Tivozanib

To evaluate the toxicity profile of Tivozanib in the entire study population during the treatment period with Tivozanib, through the evaluation of tivozanib-related toxicities reported in the patients' medical history

Time frame: Day 1