Renal Cell Cancer MetastaticSOGUG-TIVOREALNCT07354282
Real World Evidence of Tivozanib as First-line Treatment for Metastatic Clear Cell Renal Cell Carcinoma
An observational study of Renal Cell Cancer Metastatic, run by Spanish Oncology Genito-Urinary Group at 14 sites in Spain.
Trial summary
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). Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Renal Cell Cancer Metastatic
- How many people
- 200 participants
- Where
- 14 sitesSpain
- Study dates
- 13 May 2025to 7 Aug 2025
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
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.
Who may be able to join
- - 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.
Who cannot join
- - 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.
Trial locations and contacts
14 sites in 1 country.
14 sites in 1 country
Spain14 sites
Hospital Vall de Hebron
Barcelona, Catalonia
Hospital de Burgos
Burgos, Castille and León
Hospital Reina Sofia
Córdoba, Andalusia
Institut Català d'Oncologia (ICO) de L'Hospitalet de Llobregat
L'Hospitalet de Llobregat, Catalonia
Hospital Severo Ochoa
Leganés, Madrid
Hospital de Leon
León, Castille and León
Hospital Lucus Augusti
Lugo, Galicia
Fundacion Jimenez Diaz
Madrid, Madrid
Hospital Gregorio Marañon
Madrid, Madrid
Hospital Puerta de Hierro
Majadahonda, Madrid
Hospital Virgen de la Victoria
Málaga, Andalusia
Hospital Parc Tauli
Sabadell, Catalonia
Hospital Virgen del Rocio
Seville, Andalusia
Instituto Valenciano de Oncologia (IVO)
Valencia, Valencia
About this study
Official title: 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).
- Conditions
- Renal Cell Cancer Metastatic
- Keywords
- Tivozanib
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: Day 1
Secondary outcomes (8)
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
Measured: 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
Measured: 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
Measured: Day 1
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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: Day 1
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Jan 2026
- Study start13 May 2025
- Primary completion7 Aug 2025
- Study completion7 Aug 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Renal Cell Cancer MetastaticStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case only
- Time perspective
- Retrospective
- Enrolment
- 200 participants (actual)
Sponsor and investigators
- Lead sponsor
- Spanish Oncology Genito-Urinary Group
- Sponsor type
- University, hospital or other
- Collaborators
- Adknoma Health Research
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07354282
- Sponsor's protocol ID
- SOGUG-2024-IEC(REN)-1
- Acronym
- SOGUG-TIVOREAL
- Status last verified
- Jan 2026
- First submitted
- 24 Sep 2025
- Last updated
- 21 Jan 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 21 Jan 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Retrospective, Multicenter, Real-world Observational Study of Tivozanib as First-line Treatment for Metastatic Clear Cell Renal Cell Carcinoma.
- ClinicalTrials.gov ID
- NCT07354282
- Acronym / sponsor ID
- SOGUG-TIVOREAL / SOGUG-2024-IEC(REN)-1
- Conditions
- Renal Cell Cancer Metastatic
- Keywords
- Tivozanib
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 200 participants (actual)
- Lead sponsor
- Spanish Oncology Genito-Urinary GroupUniversity, hospital or other
- Collaborators
- Adknoma Health Research
- Study start
- 13 May 2025 (actual)
- Primary completion
- 7 Aug 2025 (actual)
- Study completion
- 7 Aug 2025 (actual)
- First posted
- 21 Jan 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Case only
- Time perspective
- Retrospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- 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.
Key inclusion criteria (5 listed)
- - 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.
Key exclusion criteria (2 listed)
- - 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
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
8 secondary outcomes
Overall survival (OS) in favorable risk group
Time frame: Day 1
Objective response rate (ORR) in favorable risk group
Time frame: Day 1
Percentage of patients with PR and CR in favorable risk group
Time frame: Day 1
Progression-free survival (PFS) - Intermediate and poor risk group
Time frame: Day 1
Overall survival (OS) - Intermediate and poor risk group
Time frame: Day 1
Objective response rate (ORR) in poor and intermediate risk group
Time frame: Day 1
Percentage of patients with PR and CR in intermediate and poor risk group
Time frame: Day 1
Toxicity profile of Tivozanib
Time frame: Day 1
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Jan 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
14 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Renal Cell Cancer Metastatic, run by Spanish Oncology Genito-Urinary Group at 14 sites in Spain.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 21 Jan 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 14 sites in Spain. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Progression-free survival (PFS) (time frame: Day 1). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 21 Jan 2026.