First-Line Systemic Therapies in Advanced Renal Cell Carcinoma in Spain

NCT07852884 | Active Not Recruiting FDA Drug

• 1 other identifier: CA209-1591
• Study Type: observational
• Target: 1,200
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Renal Cell Carcinoma (RCC)

Keywords

Renal cell carcinoma (RCC); advanced renal cell carcinoma (aRCC); metastatic renal cell carcinoma (mRCC)

Outcome Measures

Primary Outcomes (1)

• Overall survival from index date to death from any cause

  Up to 7 years

Secondary Outcomes (13)

• Progression-free survival from index date to progression or death

  Up to 7 years

• Objective response rate (ORR) based on documented complete or partial response

  Up to 7 years

• Duration of response (DoR) from first documented response to progression or death

  Up to 7 years

• Time to response (TRR) from index date to first documented response

  Up to 7 years

• Treatment-free survival (TFS) after discontinuation of first-line treatment

  Up to 7 years

Study Arms (1)

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.

Drug: First-line systemic regimens

Interventions

First-line systemic regimens DRUG

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

Intermediate- and poor-risk advanced or metastatic renal cell carcinoma

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

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.

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Bristol-Myers Squibb: lead

Study Sites (1)

Local Institution - 0001

Madrid, 28001, Spain

Location

Related Links

• BMS Clinical Trial Information
• FDA Safety Alerts and Recalls

MeSH Terms

Conditions

Carcinoma, Renal Cell

Condition Hierarchy (Ancestors)

Adenocarcinoma; Carcinoma; Neoplasms, Glandular and Epithelial; Neoplasms by Histologic Type; Neoplasms; Kidney Neoplasms; Urologic Neoplasms; Urogenital Neoplasms; Neoplasms by Site; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Kidney Diseases; Urologic Diseases; Male Urogenital Diseases

Study Officials

• Bristol-Myers Squibb

  Bristol-Myers Squibb

  STUDY DIRECTOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: RETROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 24, 2026
• First Posted: October 1, 2026
• Study Start: July 15, 2026
• Primary Completion: September 1, 2026
• Study Completion (Estimated): December 1, 2026
• Last Updated: October 1, 2026

Record last verified: 2026-09

Data Sharing

• IPD Sharing: Will not share

Locations

ES (1)