Spanish Real-World Evidence Cabozantinib (SRWEC)

Study of the Effectiveness and Safety of Cabozantinib Treatment in Patients With Advanced Renal Cell Carcinoma (RCC) Under a Spanish Managed Access Program and Real-world Practice

RCC (Renal Cell Carcinoma) is the most common form of kidney cancer, accounting for 2-3% of all adult malignancies and for 90% of all kidney cancers. The incidence of RCC has steadily increased over the past two decades, showing a plateau in recent years. Many patients with RCC remain asymptomatic until late disease stages and other patients have disease at diagnosis (metastatic RCC or mRCC).

Recently, the tyrosine kinase inhibitor (TKI) cabozantinib was approved as a first-line therapy for patients with advanced clear-cell RCC (ccRCC). Cabozantinib was initially approved for patients previously treated with antiangiogenic therapy based on the phase 3 METEOR study, which demonstrated a clinical benefit compared with everolimus.

Immunotherapy has been also developed in ccRCC.

The frontline treatment paradigm for ccRCC has evolved, particularly for intermediate-/poor-risk patients, with the recent addition of cabozantinib and nivolumab/ipilimumab (immunotherapy), but overall survival data are needed to understand their benefit-to-risk profiles compared with established therapies.

In October 2016, the Spanish Agency of medicines (AEMPS) granted the temporary Authorization for special use to Cabometyx® 20/40/60 mg within a Managed Access Program (MAP) for the treatment of advanced RCC in adults following prior VEGF-targeted therapy (Vascular Endothelial Growth Factor targeted therapy). The MAP allows the possibility of using a medicinal product which is not yet commercially available or approved. By the end of the MAP period, on July 2017, 136 patients had been included by 61 centers who received at least one dose of Cabometyx® for the treatment of advanced RCC.

Since then, Cabometyx® 20/40/60 mg was made commercially available for the treatment of advanced RCC in adults following prior VEGF-targeted therapy. After the commercialization of Cabometyx® in July 2017 in Spain, the inclusion of new patients in the MAP was closed but those patients that were already included continued receiving Cabometyx® free of charge until clinical decision. In July 2018, the European Commission approved a new indication for adult patients previously untreated with intermediate or poor risk.

Based on this rationale, the aim of this study is to obtain safety and effectiveness information regarding the use of cabozantinib in a non-selected RCC population, both in patients that received this agent under the MAP or under routine clinical prescription (real-world [RW]).

Study Overview

• Status: Completed
• Conditions: Renal Cell Carcinoma
• Intervention / Treatment: Drug: Cabozantinib

• Study Type: Observational
• Enrollment (Actual): 275

Contacts and Locations

Study Locations

• Spain
  • Barcelona, Spain, 08003
    • Hospital del Mar
  • Barcelona, Spain, 08036
    • Hospital Clinic de Barcelona
  • Barcelona, Spain, 08035
    • Hospital Universitari Vall d'Hebron
  • Burgos, Spain, 09006
    • Hospital Universitario de Burgos
  • Castellón De La Plana, Spain, 12002
    • Hospital Provincial de Castellon
  • Ciudad Real, Spain, 13005
    • Hospital General de Ciudad Real
  • Cáceres, Spain, 10003
    • Hospital San Pedro de Alcántara
  • Lugo, Spain, 27003
    • Hospital Universitario Lucus Augusti
  • Toledo, Spain, 45004
    • Hospital Virgen de la Salud
  • Valencia, Spain, 46009
    • Fundacion Instituto Valenciano de Oncologia
  • Valencia, Spain, 46015
    • Hospital Arnau de Vilanova
  • Vigo, Spain, 36312
    • Hospital Universitario Alvaro Cunqueiro
  • Andalucía
    • Córdoba, Andalucía, Spain, 14004
      • Hospital Universitario Reina Sofía
    • Huelva, Andalucía, Spain, 21005
      • Hospital Universitario Juan Ramon Jimenez
    • Jaén, Andalucía, Spain, 23007
      • Complejo Hospitalario de Jaén
  • Asturias
    • Oviedo, Asturias, Spain, 33011
      • Hospital Universitario Central de Asturias
  • Barcelona
    • Sabadell, Barcelona, Spain, 08208
      • Hospital Universitari Parc Tauli
  • Castilla Y León
    • León, Castilla Y León, Spain, 24008
      • Hospital Universitario de Leon
  • Catalonia
    • Barcelona, Catalonia, Spain, 08041
      • Hospital De La Santa Creu I Sant Pau
  • Catalunya
    • Reus, Catalunya, Spain, 43204
      • Hospital Universitari Sant Joan de Reus
    • Sabadell, Catalunya, Spain, 08208
      • Consorci Corporació Sanitària Parc Taulí de Sabadell
  • Comunidad Valenciana
    • Valencia, Comunidad Valenciana, Spain, 46026
      • Hospital Universitari i Politecnic La Fe
  • Comunitat Valenciana
    • Valencia, Comunitat Valenciana, Spain, 46010
      • Hospital Clínico Universitario de Valenica
    • Valencia, Comunitat Valenciana, Spain, 46017
      • Hospital Universitari Dr. Peset
  • Extremadura
    • Badajoz, Extremadura, Spain, 06080
      • Hospital Universitario de Badajoz
  • Galicia
    • A Coruña, Galicia, Spain, 15009
      • Centro Oncologico de Galicia
    • Ferrol, Galicia, Spain, 15405
      • Complejo Hospitalario Universitario de Ferrol
    • Ourense, Galicia, Spain, 32005
      • Complejo Hospitalario Universitario Ourense
  • Illes Ballears
    • Palma De Mallorca, Illes Ballears, Spain, 07120
      • Hospital Universitari Son Espases
  • Islas Baleares
    • Palma De Mallorca, Islas Baleares, Spain, 07198
      • Hospital Son Llàtzer
  • Islas Canarias
    • Las Palmas De Gran Canaria, Islas Canarias, Spain, 35010
      • Hospital Unviersitario de Gran Canaria Doctor Negrin
    • Santa Cruz De Tenerife, Islas Canarias, Spain, 38010
      • Hospital Universitario Nuestra Señora de Candelaria

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 14 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

Data from patients with Renal Cell Carcinoma (RCC) currently under tretament at the study site or data from deceased patients with RCC

Description

Inclusion Criteria:

1. Male or females, aged 18 years or older.
2. Diagnosis of advanced Renal Cell Carcinoma (RCC)
3. Alive or dead patients at study initiation who received at least one dose of cabozantinib for the treatment of RCC between October 2016 and 1 st June 2019.
4. Alive patients who agree to participate and signed the Informed Consent Form (ICF).

Exclusion Criteria:

1. Patients who decline consent.
2. Patients whose hospital medical records are unavailable for review.

Study Plan

How is the study designed?

Design Details

• Observational Models: Case-Only
• Time Perspectives: Other

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Managed Access Program (MAP) patients; Patients with RCC treated with cabozantinib under a Managed Access Program (MAP) prior to Cabometyx® marketing authorization	Drug: Cabozantinib; Observation of treatment with Cabozantinib
Real World (RW) patients; Patients with RCC treated with cabozantinib as routine clinical prescription (Real World), with treatment started after Cabometyx® marketing authorization	Drug: Cabozantinib; Observation of treatment with Cabozantinib

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Effectiveness: Progression-Free Survival	Evaluation of the effectiveness of cabozantinib in terms of investigator-assessed PFS (Progression-Free Survival) based on the Response Evaluation Criteria in Solid Tumors (RECIST) 1.1	Through study completion, an average of 2 years
Incidence of Adverse Reactions	Evaluation of the safety of cabozantinib by recording the incidence of adverse reactions in both MAP and RW cohorts.	Through study completion, an average of 2 years
Incidence of dose reductions	Evaluation of the safety of cabozantinib by recording the incidence of dose reductions in both MAP and RW cohorts.	Through study completion, an average of 2 years
Incidence of temporary interruptions or discontinuations	Evaluation of the safety of cabozantinib by recording the Incidence of temporary interruptions or discontinuations in both MAP and RW cohorts.	Through study completion, an average of 2 years
Incidence of use of medications to manage adverse reactions	Evaluation of the safety of cabozantinib by recording the incidence of use of medications to manage adverse reactions in both MAP and RW cohorts.	Through study completion, an average of 2 years

Collaborators and Investigators

• Sponsor: Spanish Oncology Genito-Urinary Group
• Collaborators: Ipsen; Syntax for Science, S.L
• Investigators: Principal Investigator: Cristina Suárez, MD, Investigator

Study record dates

Study Major Dates

• Study Start (Actual): October 23, 2019
• Primary Completion (Actual): June 30, 2022
• Study Completion (Actual): June 30, 2022

Study Registration Dates

• First Submitted: June 29, 2020
• First Submitted That Met QC Criteria: August 10, 2020
• First Posted (Actual): August 12, 2020

Study Record Updates

• Last Update Posted (Actual): October 26, 2022
• Last Update Submitted That Met QC Criteria: October 25, 2022
• Last Verified: October 1, 2022

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Neoplasms by Histologic Type; Neoplasms; Urologic Neoplasms; Urogenital Neoplasms; Neoplasms by Site; Kidney Diseases; Urologic Diseases; Adenocarcinoma; Neoplasms, Glandular and Epithelial; Kidney Neoplasms; Carcinoma, Renal Cell; Carcinoma
• Other Study ID Numbers: SOGUG-2017-A-IEC(REN)-7

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