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Completed

NCT Number: NCT07354282

Real World Evidence 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).

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Key information

Conditions

Renal Cell Cancer Metastatic

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Hospital Reina Sofia, Córdoba, Andalusia, Spain

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • - Patients ≥ 18 years old.
  • - Who have signed the informed consent form, except for patients who were deceased at the time of inclusion.
  • - Histological diagnosis of stage IV clear cell renal carcinoma.
  • - Who started treatment with Tivozanib as first-line therapy between March 1, 2019, and August 31, 2024.
  • - Who received treatment at the participating center.

Exclusion criteria

  • - 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.
  • - Explicit objection by the subject or their legal representative to participate in the study.

Treatment and study plan

Primary outcomes

  1. 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

Secondary outcomes

  1. 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

  2. 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

  3. 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

  4. 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

  5. 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

  6. 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

  7. 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

  8. 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

Sponsors and collaborators

Lead sponsor

Spanish Oncology Genito-Urinary Group

Other

Collaborators

  • Adknoma Health Research

Registry information

Official study title

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

Acronym: SOGUG-TIVOREAL

Important dates

Study start
2025
Primary completion
2025
Study completion
2025
First posted
Jan 21, 2026
Registry last updated
Jan 21, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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