Nivolumab in the Real World: Analysis of the Expanded Use in Spanish Patient
NIVEX
A Retrospective, Multicenter and Observational Study of Nivolumab Monotherapy Treatment in Subjects With Advanced or Metastatic Squamous (Sq) or Non-Squamous (Non-Sq) Non-Small Cell Lung Cancer (NSCLC) Who Have Received at Least One Prior Systemic Regimens for the Treatment of Stage IIIb/IV NSCLC Within the Expanded Access Program (EAP) in SPAIN
1 other identifier
observational
676
1 country
61
Brief Summary
The investigators will be retrospectively review the case note of patients registered in the EAP of Nivolumab. A standard anonymous data collection form will be used to collect data and to analyze it. Patients with advanced Non-Small Cell Lung Cancer previously treated and included in the SPANISH expanded access programme of nivolumab.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for all trials
Started Jun 2017
61 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
April 25, 2017
CompletedFirst Posted
Study publicly available on registry
April 27, 2017
CompletedStudy Start
First participant enrolled
June 1, 2017
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 1, 2017
CompletedStudy Completion
Last participant's last visit for all outcomes
September 15, 2018
CompletedNovember 14, 2018
November 1, 2018
6 months
April 25, 2017
November 12, 2018
Conditions
Outcome Measures
Primary Outcomes (1)
Progression Free survival
time from inclusion to progression
At 12 months
Secondary Outcomes (1)
Overall Response rate
At 12 months
Interventions
nivolumab 3 mg/kg as an intravenous infusion every 2 weeks until progression
Eligibility Criteria
Patients eligible for the trial are those treated in the EAP of nivolumab in Spain. The total number of patients to be included will be 1400 from 150 participating sites in Spain (anticipated data)
You may qualify if:
- Squamous or Non-Squamous, non small cell lung cancer (NSCLC), Stage IIIb/IV (histologically or cytologically confirmed), relapsed after 1 prior platinum-based systemic treatment and who received treatment within the SPANISH expanded access programme of nivolumab (EAP)
- Alive patients must have signed and dated an IRB/IEC-approved written informed consent form in accordance with regulatory and institutional guidelines. This must be obtained before the performance of any protocol-related procedures that are not part of normal subject care
You may not qualify if:
- Alive patients who do not want to sign and date an IRB/IEC-approved written informed consent form
- Patients who were accepted in the EAP but do not receive treatment
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (61)
Hospital Virgen de los Lirios
Alcoy, Alicante, 03804, Spain
Hospital de Elche
Elche, Alicante, 03202, Spain
Hospital Universitario de Vinalopó
Elche, Alicante, 03293, Spain
Hospital General Universitario de Elda
Elda, Alicante, 03600, Spain
H. Germans Trias i Pujol
Badalona, Barcelona, 08916, Spain
Hospital de Mataró
Mataró, Barcelona, 08304, Spain
Corporació Sanitaria Parc Taulí
Sabadell, Barcelona, 08208, Spain
Consorci Sanitari de Terrassa
Terrassa, Barcelona, 08220, Spain
Hospital Universitari Mútua de Terrassa
Terrassa, Barcelona, 08221, Spain
Hospital de Galdakao
Galdakao, Bizkaia, 48960, Spain
Hospital Universitario de Donostia
Donostia / San Sebastian, Gipuzkoa, 20014, Spain
Centro Oncológico de Galicia
A Coruña, La Coruña, 15009, Spain
Hospital Insular de Gran Canaria
Las Palmas de Gran Canaria, Las Palmas, Spain
Hospital Universitario Fundación Alcorcón
Alcorcón, Madrid, 28922, Spain
Hospital Universitario de Fuenlabrada
Fuenlabrada, Madrid, 28942, Spain
Hospital Severo Ochoa
Leganés, Madrid, 28911, Spain
Hospital Universitario de Móstoles
Móstoles, Madrid, 28935, Spain
Hospital Universitario Infanta Cristina
Parla, Madrid, 28981, Spain
Hospital Universitario Quirón Madrid
Pozuelo de Alarcón, Madrid, Madrid, Spain
Clínica Universitaria de Navarra
Pamplona, Navarre, 31008, Spain
Complejo Hospitalario de Navarra
Pamplona, Navarre, 31008, Spain
Hospital Sant Joan de Reus
Reus, Tarragona, 43204, Spain
Hospital Lluís Alcanyís
Xàtiva, Valencia, 46800, Spain
Hospital de Cruces
Barakaldo, Vizcaya, 48903, Spain
Hospital de Basurto
Bilbao, Vizcaya, 48013, Spain
Hospital Universitario a Coruña
A Coruña, 15006, Spain
Hospital del Mar
Barcelona, 08003, Spain
Hospital Vall d' Hebron
Barcelona, 08035, Spain
H. Universitario Quirón Dexeus
Barcelona, 08036, Spain
Hospital de Sant Pau Y de La Santa Creu
Barcelona, 08036, Spain
H. Althaia
Barcelona, 08243, Spain
Hospital Virgen de la Luz
Cuenca, 16002, Spain
Hospital Dr. Josep Trueta
Girona, 17007, Spain
Hospital Clínico San Cecilio
Granada, 18012, Spain
Hospital de Guadalajara
Guadalajara, 19002, Spain
Complejo Hospitalario de Jaén
Jaén, 23007, Spain
Complejo Asistencial Universitario de León
León, 24071, Spain
Hospital Universitario Lucus Augusti
Lugo, 27003, Spain
Hospital General Universitario Gregorio Marañón
Madrid, 28007, Spain
MD Anderson Cancer Center
Madrid, 28033, Spain
H.U. Puerta de Hierro
Madrid, 28035, Spain
Fundación Jimenez Diaz
Madrid, 28040, Spain
Hospital Clínico San Carlos
Madrid, 28040, Spain
Hospital Universitario Infanta Sofía
Madrid, 28703, Spain
H. Carlos Haya
Málaga, 29010, Spain
Hospital Universitario Virgen de la Victoria
Málaga, 29010, Spain
H. Morales Messeguer
Murcia, 30008, Spain
Hospital Clínico Universitario Virgen de la Arrixaca
Murcia, 30120, Spain
Hospital Son Espases
Palma de Mallorca, 07010, Spain
H. Son Llàtzer
Palma de Mallorca, 07198, Spain
Hospital Clinico de Salamanca
Salamanca, 37007, Spain
Hospital Nuestra Señora Candelaria
Santa Cruz de Tenerife, 38010, Spain
Hospital Virgen del Rocío
Seville, 41013, Spain
Instituto Valenciano de Oncología
Valencia, 46009, Spain
Hospital General de Valencia
Valencia, 46014, Spain
Hospital Dr. Peset
Valencia, 46017, Spain
Hospital de Sagunto
Valencia, 46500, Spain
Hospital La Fe
Valencia, Spain
Hospital Clínico Universitario de Valladolid
Valladolid, 47003, Spain
H. Miguel Servet
Zaragoza, 50009, Spain
Hospital Universitario de Áraba
Vitoria-Gasteiz, Áraba, 01009, Spain
Related Links
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Delvys Rodríguez, MD, PhD
Hospital Universitario Insular de Gran Canaria
- PRINCIPAL INVESTIGATOR
Margarita Majem, MD, PhD
Fundació Institut de Recerca de l'Hospital de la Santa Creu i Sant Pau
Study Design
- Study Type
- observational
- Observational Model
- COHORT
- Time Perspective
- RETROSPECTIVE
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
April 25, 2017
First Posted
April 27, 2017
Study Start
June 1, 2017
Primary Completion
December 1, 2017
Study Completion
September 15, 2018
Last Updated
November 14, 2018
Record last verified: 2018-11
Data Sharing
- IPD Sharing
- Will not share