Clinical trial NCT04510688: Spanish Real-World Evidence Cabozantinib
Official title: 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
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Renal Cell Carcinoma
Lead sponsor: Spanish Oncology Genito-Urinary Group
Sponsor class: OTHER
Collaborators: name: Syntax for Science, S.L
name: Ipsen
First posted: 2020-08-12
Enrollment: 275
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: OTHER
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

Brief summary: 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 \[RW\]).


Eligibility criteria: 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.

Primary outcomes:
measure: Effectiveness: Progression-Free Survival
timeFrame: Through study completion, an average of 2 years
measure: Incidence of Adverse Reactions
timeFrame: Through study completion, an average of 2 years
measure: Incidence of dose reductions
timeFrame: Through study completion, an average of 2 years
measure: Incidence of temporary interruptions or discontinuations
timeFrame: Through study completion, an average of 2 years
measure: Incidence of use of medications to manage adverse reactions
timeFrame: Through study completion, an average of 2 years
Secondary outcomes:
Other outcomes:
Locations:
city: Córdoba
country: Spain
facility: Hospital Universitario Reina Sofía
state: Andalucía
city: Huelva
country: Spain
facility: Hospital Universitario Juan Ramón Jiménez
state: Andalucía
city: Jaén
country: Spain
facility: Complejo Hospitalario de Jaén
state: Andalucía
city: Oviedo
country: Spain
facility: Hospital Universitario Central de Asturias
state: Asturias
city: Sabadell
country: Spain
facility: Hospital Universitari Parc Taulí
state: Barcelona
city: León
country: Spain
facility: Hospital Universitario de León
state: Castilla Y León
city: Barcelona
country: Spain
facility: Hospital de la Santa Creu i Sant Pau
state: Catalonia
city: Reus
country: Spain
facility: Hospital Universitari Sant Joan de Reus
state: Catalunya
city: Sabadell
country: Spain
facility: Consorci Corporació Sanitària Parc Taulí de Sabadell
state: Catalunya
city: Valencia
country: Spain
facility: Hospital Universitari i Politècnic La Fe
state: Comunidad Valenciana
city: Valencia
country: Spain
facility: Hospital Clínico Universitario de Valenica
state: Comunitat Valenciana
city: Valencia
country: Spain
facility: Hospital Universitari Dr. Peset
state: Comunitat Valenciana
city: Badajoz
country: Spain
facility: Hospital Universitario de Badajoz
state: Extremadura
city: A Coruña
country: Spain
facility: Centro Oncológico de Galicia
state: Galicia
city: Ferrol
country: Spain
facility: Complejo Hospitalario Universitario de Ferrol
state: Galicia
city: Ourense
country: Spain
facility: Complejo Hospitalario Universitario Ourense
state: Galicia
city: Palma De Mallorca
country: Spain
facility: Hospital Universitari Son Espases
state: Illes Ballears
city: Palma De Mallorca
country: Spain
facility: Hospital Son Llatzer
state: Islas Baleares
city: Las Palmas De Gran Canaria
country: Spain
facility: Hospital Unviersitario de Gran Canaria Doctor Negrin
state: Islas Canarias
city: Santa Cruz De Tenerife
country: Spain
facility: Hospital Universitario Nuestra Señora de Candelaria
state: Islas Canarias
city: Barcelona
country: Spain
facility: Hospital Del Mar
city: Barcelona
country: Spain
facility: Hospital Universitari Vall D'Hebron
city: Barcelona
country: Spain
facility: Hospital Clínic de Barcelona
city: Burgos
country: Spain
facility: Hospital Universitario de Burgos
city: Castellón De La Plana
country: Spain
facility: Hospital Provincial de Castellón
city: Ciudad Real
country: Spain
facility: Hospital General de Ciudad Real
city: Cáceres
country: Spain
facility: Hospital San Pedro de Alcántara
city: Lugo
country: Spain
facility: Hospital Universitario Lucus Augusti
city: Toledo
country: Spain
facility: Hospital Virgen de La Salud
city: Valencia
country: Spain
facility: Fundación Instituto Valenciano de Oncología
city: Valencia
country: Spain
facility: Hospital Arnau de Vilanova
city: Vigo
country: Spain
facility: Hospital Universitario Alvaro Cunqueiro
Study officials:
affiliation: Investigator
name: Cristina Suárez, MD
role: PRINCIPAL_INVESTIGATOR
References: