Renal Cell Carcinoma (RCC)INSPIRE-RCCNCT07852884
First-Line Systemic Therapies in Advanced Renal Cell Carcinoma in Spain
An observational study of Renal Cell Carcinoma (RCC), run by Bristol-Myers Squibb at 1 site in Spain.
Trial summary
This retrospective observational study will use anonymized electronic medical records from the BIG-PAC® database to describe outcomes and treatment management for adults in Spain with advanced or metastatic renal cell carcinoma who start first-line systemic therapy. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Renal Cell Carcinoma (RCC)
- What is being tested?
- First-line systemic regimens
- How many people
- 1,200 participants
- Where
- 1 siteSpain
- Study dates
- 15 Jul 2026to 1 Dec 2026
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
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: Adults (≥18 years) in Spain with a confirmed diagnosis of advanced or metastatic renal cell carcinoma who initiate first-line systemic therapies from January 1, 2019, to December 31, 2024.
Who may be able to join
- Age ≥18 years at the index date.
- Documented diagnosis of advanced renal cell carcinoma (aRCC) identified through International Classification of Diseases (ICD) 9 codes recorded in medical history
- Initiation of first-line systemic therapies within the study selection period (January 1, 2019, to December 31, 2024).
- A minimum of 12 months of follow-up data available after the index date, unless the participant dies earlier.
- Availability of sufficient clinical data for evaluation of primary endpoints [overall survival (OS), progression-free survival (PFS), objective response rate (ORR), duration of response (DoR), time to response (TTR), safety).
- Documented clinical follow-up at the treating center during first-line systemic therapies and at least one post-treatment initiation follow-up record.
- Note: International Metastatic RCC Database Consortium (IMDC) classification is not an inclusion criterion; IMDC intermediate/poor defines the primary analysis cohort
Who cannot join
- Insufficient clinical information in the electronic medical records (EMR) to evaluate the study outcomes (OS, PFS, ORR, safety).
- Participation in an interventional clinical trial during treatment with first-line systemic therapies that may affect clinical or safety outcomes.
- Receipt of first line treatments outside routine clinical practice, such as compassionate use, expanded access, or off-label administration when relevant to the study objectives.
- Diagnosis is inconsistent with advanced or metastatic RCC, including non-epithelial renal tumors or histology not aligned with the study population.
- Age <18 years at the time of first-line systemic therapies initiation.
- If additional data-driven exclusions are identified during data validation, they may be described in the Statistical Analysis Plan (SAP) but will not be added as protocol-defined criteria.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Retrospective Observational Study on Clinical Outcomes and Treatment Management of First-Line Systemic Therapies in Patients With Advanced Renal Cell Carcinoma in Spain Using the BIG-PAC® Database
This retrospective observational study will use anonymized electronic medical records from the BIG-PAC® database to describe outcomes and treatment management for adults in Spain with advanced or metastatic renal cell carcinoma who start first-line systemic therapy.
- Conditions
- Renal Cell Carcinoma (RCC)
- Being tested
- First-line systemic regimens
- Keywords
- Renal cell carcinoma (RCC), advanced renal cell carcinoma (aRCC), metastatic renal cell carcinoma (mRCC)
- Medical subject headings
- Carcinoma, Renal Cell
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
First-line systemic regimensDrug
First-line systemic regimens for advanced or metastatic renal cell carcinoma include: nivolumab plus ipilimumab, axitinib plus avelumab, axitinib plus pembrolizumab, lenvatinib plus pembrolizumab, cabozantinib plus nivolumab, cabozantinib, tivozanib, sunitinib, and pazopanib
| Study group | Role | What they receive |
|---|---|---|
| Intermediate- and poor-risk advanced or metastatic renal cell carcinoma | Participants diagnosed with advanced or metastatic renal cell carcinoma who initiated a first-line systemic regimen during the study period and were classified as International Metastatic RCC Database Consortium intermediate- or poor-risk. Receives: Drug: First-line systemic regimens |
What is being measured
The primary outcome is the main question the study is designed to answer.
Overall survival from index date to death from any cause
Measured: Up to 7 years
Secondary outcomes (13)
Progression-free survival from index date to progression or death
Measured: Up to 7 years
Objective response rate (ORR) based on documented complete or partial response
Objective response rate is defined as the proportion of participants with documented partial response or complete response based on oncology or radiology electronic medical record entries.
Measured: Up to 7 years
Duration of response (DoR) from first documented response to progression or death
Measured: Up to 7 years
Time to response (TRR) from index date to first documented response
Measured: Up to 7 years
Treatment-free survival (TFS) after discontinuation of first-line treatment
Treatment-free survival is defined as the time from documented discontinuation of first-line treatment to the earliest of initiation of any subsequent systemic anti-cancer therapy or death.
Measured: Up to 7 years
Outcome 6 Title Number of participants with adverse events
Measured: Up to 7 years
Healthcare resource utilization during follow-up
Healthcare resource utilization includes all-cause hospitalizations, emergency room visits, outpatient visits, diagnostic procedures including computed tomography, magnetic resonance imaging, and laboratory assessments, and systemic therapy administrations.
Measured: Up to 7 years
Direct healthcare costs during follow-up
Direct healthcare costs are estimated using a unit-cost method applied to medications and healthcare resource utilization. Cost categories include medication costs, hospital service costs, outpatient care costs, diagnostic procedure costs, supportive care costs, and total direct cost.
Measured: Up to 7 years
Treatment duration from first-line therapy dose to discontinuation, switch, or end of follow-up
Measured: Up to 7 years
Number of ipilimumab doses administered to participants receiving first-line nivolumab plus ipilimumab
Measured: Up to 7 years
Number of participants that discontinue treatment
Measured: Up to 7 years
Subsequent systemic therapy regimens prescribed after first-line treatment discontinuation
Measured: Up to 7 years
Number of participants with prior adjuvant anti-programmed cell death protein 1 (PD-1) exposure
Measured: Up to 12 months prior to Index Date
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Oct 2026
- Study start15 Jul 2026
- Primary completion1 Sep 2026
- Study completion1 Dec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Renal Cell Carcinoma (RCC)Studies of the same condition, open and under way.
- More trials run by Bristol-Myers SquibbThe sponsor's other registered studies.
- 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
- Cohort
- Time perspective
- Retrospective
- Enrolment
- 1,200 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Bristol-Myers Squibb
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Bristol-Myers Squibb, Study director, Bristol-Myers Squibb
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07852884
- Sponsor's protocol ID
- CA209-1591
- Acronym
- INSPIRE-RCC
- Status last verified
- Sep 2026
- First submitted
- 24 Sep 2026
- Last updated
- 1 Oct 2026
- Results posted
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 1 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Retrospective Observational Study on Clinical Outcomes and Treatment Management of First-Line Systemic Therapies in Patients With Advanced Renal Cell Carcinoma in Spain Using the BIG-PAC® Database
- ClinicalTrials.gov ID
- NCT07852884
- Acronym / sponsor ID
- INSPIRE-RCC / CA209-1591
- Conditions
- Renal Cell Carcinoma (RCC)
- Keywords
- Renal cell carcinoma (RCC), advanced renal cell carcinoma (aRCC), metastatic renal cell carcinoma (mRCC)
- Study type
- Observational
- Recruitment status
- Active, not recruiting
- Enrolment
- 1,200 participants (estimated)
- Lead sponsor
- Bristol-Myers SquibbIndustry (pharma, biotech, devices)
- Study start
- 15 Jul 2026 (actual)
- Primary completion
- 1 Sep 2026 (actual)
- Study completion
- 1 Dec 2026 (estimated)
- First posted
- 1 Oct 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.
This retrospective observational study will use anonymized electronic medical records from the BIG-PAC® database to describe outcomes and treatment management for adults in Spain with advanced or metastatic renal cell carcinoma who start first-line systemic therapy.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Intermediate- and poor-risk advanced or metastatic renal cell carcinoma | – | Drug: First-line systemic regimensParticipants diagnosed with advanced or metastatic renal cell carcinoma who initiated a first-line systemic regimen during the study period and were classified as International Metastatic RCC Database Consortium intermediate- or poor-risk. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Adults (≥18 years) in Spain with a confirmed diagnosis of advanced or metastatic renal cell carcinoma who initiate first-line systemic therapies from January 1, 2019, to December 31, 2024.
Key inclusion criteria (7 listed)
- Age ≥18 years at the index date.
- Documented diagnosis of advanced renal cell carcinoma (aRCC) identified through International Classification of Diseases (ICD) 9 codes recorded in medical history
- Initiation of first-line systemic therapies within the study selection period (January 1, 2019, to December 31, 2024).
- A minimum of 12 months of follow-up data available after the index date, unless the participant dies earlier.
- Availability of sufficient clinical data for evaluation of primary endpoints [overall survival (OS), progression-free survival (PFS), objective response rate (ORR), duration of response (DoR), time to response (TTR), safety).
Key exclusion criteria (6 listed)
- Insufficient clinical information in the electronic medical records (EMR) to evaluate the study outcomes (OS, PFS, ORR, safety).
- Participation in an interventional clinical trial during treatment with first-line systemic therapies that may affect clinical or safety outcomes.
- Receipt of first line treatments outside routine clinical practice, such as compassionate use, expanded access, or off-label administration when relevant to the study objectives.
- Diagnosis is inconsistent with advanced or metastatic RCC, including non-epithelial renal tumors or histology not aligned with the study population.
- Age <18 years at the time of first-line systemic therapies initiation.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| First-line systemic regimensFirst-line systemic regimens for advanced or metastatic renal cell carcinoma include: nivolumab plus ipilimumab, axitinib plus avelumab, axitinib plus pembrolizumab, lenvatinib plus pembrolizumab, cabozantinib plus nivolumab, cabozantinib, tivozanib, sunitinib, and pazopanib | Drug | Intermediate- and poor-risk advanced or metastatic renal cell carcinoma |
Primary outcome
Overall survival from index date to death from any cause
Time frame: Up to 7 years
13 secondary outcomes
Progression-free survival from index date to progression or death
Time frame: Up to 7 years
Objective response rate (ORR) based on documented complete or partial response
Time frame: Up to 7 years
Duration of response (DoR) from first documented response to progression or death
Time frame: Up to 7 years
Time to response (TRR) from index date to first documented response
Time frame: Up to 7 years
Treatment-free survival (TFS) after discontinuation of first-line treatment
Time frame: Up to 7 years
Outcome 6 Title Number of participants with adverse events
Time frame: Up to 7 years
Healthcare resource utilization during follow-up
Time frame: Up to 7 years
Direct healthcare costs during follow-up
Time frame: Up to 7 years
Treatment duration from first-line therapy dose to discontinuation, switch, or end of follow-up
Time frame: Up to 7 years
Number of ipilimumab doses administered to participants receiving first-line nivolumab plus ipilimumab
Time frame: Up to 7 years
Number of participants that discontinue treatment
Time frame: Up to 7 years
Subsequent systemic therapy regimens prescribed after first-line treatment discontinuation
Time frame: Up to 7 years
Number of participants with prior adjuvant anti-programmed cell death protein 1 (PD-1) exposure
Time frame: Up to 12 months prior to Index Date
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Oct 2026.
- BMS Clinical Trial InformationLink provided by the sponsor.
- FDA Safety Alerts and RecallsLink provided by the sponsor.
- 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.
Bristol-Myers Squibb study director
Bristol-Myers Squibb
1 site 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 Carcinoma (RCC), run by Bristol-Myers Squibb at 1 site 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 7 inclusion and 6 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: under way, not looking for participants, as of the sponsor's last update on 1 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site 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?
This study is still under way. Results are not available in the source record yet.
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?
Overall survival from index date to death from any cause (time frame: Up to 7 years). 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 1 Oct 2026.