The purpose of this study is to compare pembrolizumab + adjuvant chemotherapy with placebo + adjuvant chemotherapy, with or without radiotherapy, with respect to disease-free survival (DFS) as assessed radiographically by the investigator or by histopathologic confirmation of suspected disease recurrence, and with respect to overall survival (OS). The primary hypotheses are that pembrolizumab + adjuvant chemotherapy is superior to placebo + adjuvant chemotherapy, with or without radiotherapy, with respect to DFS as assessed radiographically by the investigator or by histopathologic confirmation of suspected disease recurrence, and with respect to OS.
IV infusion
IV infusion
IV infusion
IV infusion
IV infusion docetaxel 75 mg/m\^2 Q3W or 25 mg/m2 QW may be given in place of paclitaxel following sponsor consultation if a participant experiences severe hypersensitivity to paclitaxel or an adverse event requiring discontinuation of paclitaxel.
Cisplatin 75 mg/m\^2 IV infusion Q3W may be given in place of carboplatin following sponsor consultation if a participant experiences severe hypersensitivity to carboplatin or an adverse event requiring discontinuation of carboplatin.
≥4500 cGY given according to local practice, at the discretion of the investigator
If a participant receives external beam radiotherapy (EBRT), then cisplatin 50 mg/m\^2 IV infusion may be administered as a radiosensitizer at the discretion of the investigator, on days 1 and 29
Given according to local practice, at the discretion of the investigator
Buenos Aires, Argentina
Berazategui, Buenos Aires, Argentina
Caba, Buenos Aires, Argentina
Mar del Plata, Buenos Aires, Argentina
Buenos Aires, Buenos Aires F.D., Argentina
Rosario, Santa Fe Province, Argentina
Buenos Aires, Argentina
Buenos Aires, Argentina
La Rioja, Argentina