22
Participants
Start Date
May 12, 2023
Primary Completion Date
March 1, 2028
Study Completion Date
June 1, 2028
Carboplatin
"Structure: The cis-diamino (cyclobutane-1, 1 dicarboxylate) plating. Stability: 24 hours at ambient temperature in 5% glucose, sodium chloride and glucose 5% solution solution or physiologic saline. It is recommended not to dilute with chlorinated solutions for this could affect the carboplatin.~Route of administration: Intravenous infusion. Guidelines of Carboplatin administration: According to the standard of ech center."
Paclitaxel
"Structure: A diterpene whose composition is: 5b, 20-epoxy-1, 2a, 4,7b, 10b, 13a-hexa-hydroxy-11-en 9 one 4,10-diacetate 2-benzoate 13-ester with (2R,3S)- N-benzoyl-3-phenylisoserine.~Stability: Concentrations of 0.3-1.2 mg/ml in 5% dextrose or normal saline have demonstrated chemical and physical stability for more that 27 hours at ambient temperature (25ºC approximately). The intact vial must be stored between 15º and 25ºC.~Guidelines on Paclitaxel administration: Paclitaxel must be administered by infusion over 3 hours in dextrose (D5W) or normal saline (NS). The concentration must not exceed 1.2 mg/ml."
Nivolumab
"Structure: Nivolumab is a soluble protein consisting of 4 polypeptide chains. Route of administration: Intravenous infusion. Product Description: Nivolumab (BMS-936558-01) Injection drug product is a sterile, non-pyrogenic, single-use, isotonic aqueous solution formulated in 10 mg/ml.~Storage Conditions: It must be stored at 2 to 8 degrees Cº and protected from light and freezing.~Guidelines: The administration of nivolumab infusion must be completed within 24 hours of preparation.The dose of Nivolumab for the adjuvant treatment is 360 mg administered as an intravenous infusion over 30 minutes every 3 weeks (+/-3 days) for 3 cycles.~For the maintenance adjuvant treatment the dose is nivolumab 480 mg Q4W (+/-3 days) over 30 minutes for 6 months (6 cycles).~Subjects should be carefully monitored during nivolumab administration to follow infusion reactions. Doses of nivolumab may be interrupted, delayed, or discontinued depending on how well the subject tolerates the treatment."
RECRUITING
Hospital San Pedro De Alcántara, Cáceres
RECRUITING
Hospital Universitario Jerez De La Frontera, Jerez de la Frontera
RECRUITING
Hospital Josep Trueta, Girona
RECRUITING
Hospital Universitario de Jaén, Jaén
RECRUITING
Hospital Universitario Lucus Augusti, Lugo
RECRUITING
Hospital Clínico San Carlos, Madrid
RECRUITING
Hospital Universitario Fundación Jiménez Díaz, Madrid
RECRUITING
Hospital 12 De Octubre, Madrid
RECRUITING
Hospital Universitario la Paz, Madrid
RECRUITING
Hospital Universitario Puerta de Hierro, Majadahonda
RECRUITING
Hospital Universitario Regional de Málaga, Málaga
RECRUITING
Complexo Hospitalario Universitario De Vigo, Vigo
RECRUITING
Hospital Universitario Salamanca, Salamanca
RECRUITING
Hospital Universitario Virgen Del Rocio, Seville
RECRUITING
Hospital Clínico de Valencia, Valencia
RECRUITING
Hospital General Universitario de Valencia, Valencia
RECRUITING
Hospital Universitario Dr. Peset, Valencia
RECRUITING
Hospital Universitario La Fe, Valencia
RECRUITING
Hospital Clínico Universitario de Valladolid, Valladolid
RECRUITING
Hospital Universitario de Cruces, Bilbao
RECRUITING
Hospital De Mataro, Mataró
RECRUITING
Hospital General Universitario de Elche, Alicante
RECRUITING
Hospital Universitari Quiron Dexeus, Barcelona
RECRUITING
Hospital Universitari Vall d' Hebron, Barcelona
RECRUITING
Hospital Clínic De Barcelona, Barcelona
RECRUITING
Hospital Parc Taulí, Barcelona
RECRUITING
Fundació Althaïa, Manresa
RECRUITING
Hospital Son Espases, Palma de Mallorca
RECRUITING
Consorci Sanitari de Terrassa, Terrassa
Fundación GECP
OTHER