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

January 14, 2026 updated by: Spanish Oncology Genito-Urinary Group

Retrospective, Multicenter, Real-world Observational Study of Tivozanib as First-line Treatment for Metastatic Clear Cell Renal Cell Carcinoma.

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 Overview

Status

Completed

Conditions

Study Type

Observational

Enrollment (Actual)

200

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Spain
    • Andalusia
      • Córdoba, Andalusia, Spain
        • Hospital Reina Sofia
      • Málaga, Andalusia, Spain
        • Hospital Virgen de la Victoria
      • Seville, Andalusia, Spain
        • Hospital Virgen del Rocío
    • Castille and León
      • Burgos, Castille and León, Spain
        • Hospital de Burgos
      • León, Castille and León, Spain
        • Hospital de Leon
    • Catalonia
      • Barcelona, Catalonia, Spain
        • Hospital Vall de Hebron
      • L'Hospitalet de Llobregat, Catalonia, Spain
        • Institut Català d'Oncologia (ICO) de L'Hospitalet de Llobregat
      • Sabadell, Catalonia, Spain
        • Hospital Parc Tauli
    • Galicia
      • Lugo, Galicia, Spain
        • Hospital Lucus Augusti
    • Madrid
      • Leganés, Madrid, Spain
        • Hospital Severo Ochoa
      • Madrid, Madrid, Spain
        • Fundación Jiménez Díaz
      • Madrid, Madrid, Spain
        • Hospital Gregorio Maranon
      • Majadahonda, Madrid, Spain
        • Hospital Puerta de Hierro
    • Valencia
      • Valencia, Valencia, Spain
        • Instituto Valenciano de Oncologia (IVO)

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Sampling Method

Non-Probability Sample

Study Population

The population of this study consists of patients diagnosed with metastatic renal cell carcinoma (mRCC) who initiated first-line treatment with Tivozanib between March 1, 2019, and August 31, 2024.

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Progression-free survival (PFS)
Time Frame: Day 1

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
Day 1

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Overall survival (OS) in favorable risk group
Time Frame: Day 1

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
Day 1
Objective response rate (ORR) in favorable risk group
Time Frame: Day 1
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
Day 1
Percentage of patients with PR and CR in favorable risk group
Time Frame: Day 1
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
Day 1
Progression-free survival (PFS) - Intermediate and poor risk group
Time Frame: Day 1

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
Day 1
Overall survival (OS) - Intermediate and poor risk group
Time Frame: Day 1

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
Day 1
Objective response rate (ORR) in poor and intermediate risk group
Time Frame: Day 1
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
Day 1
Percentage of patients with PR and CR in intermediate and poor risk group
Time Frame: Day 1
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
Day 1
Toxicity profile of Tivozanib
Time Frame: Day 1
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
Day 1

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Spanish Oncology Genito-Urinary Group

Collaborators

Adknoma Health Research

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

May 13, 2025

Primary Completion (Actual)

August 7, 2025

Study Completion (Actual)

August 7, 2025

Study Registration Dates

First Submitted

September 24, 2025

First Submitted That Met QC Criteria

January 14, 2026

First Posted (Actual)

January 21, 2026

Study Record Updates

Last Update Posted (Actual)

January 21, 2026

Last Update Submitted That Met QC Criteria

January 14, 2026

Last Verified

January 1, 2026

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • SOGUG-2024-IEC(REN)-1

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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