Study: NCT04564157

Intervention type: DRUG
Group type: EXPERIMENTAL
Intervention: Carboplatin
Description: Structure: The cis-diamino (cyclobutan-1, 1 dicarboxilate) plating. Stability: 24 hours at ambient temperature in 5% glucose, glucosaline 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 each center.

Intervention type: DRUG
Group type: ACTIVE_COMPARATOR
Intervention: Carboplatin
Description: Structure: The cis-diamino (cyclobutan-1, 1 dicarboxilate) plating. Stability: 24 hours at ambient temperature in 5% glucose, glucosaline 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 each center.

Intervention type: DRUG
Group type: EXPERIMENTAL
Intervention: Paclitaxel
Description: Structure: A diterpene whose composition is: 5b, 20-epoxy-1, 2a, 4,7b, 10b, 13a-hexa-hidroxytax-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.

Intervention type: DRUG
Group type: ACTIVE_COMPARATOR
Intervention: Paclitaxel
Description: Structure: A diterpene whose composition is: 5b, 20-epoxy-1, 2a, 4,7b, 10b, 13a-hexa-hidroxytax-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.

Intervention type: DRUG
Group type: EXPERIMENTAL
Intervention: Nivolumab
Description: 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 4 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.