JOURNAL ONKOLOGIE – STUDIE

Studien-Informationen

Ein-/Ausschlusskriterien

Studien-Rationale

Studien-Arme

• Active Comparator: Dostarlimab plus Carboplatin-paclitaxel
  Participants will be administered dostarlimab 500 milligram (mg) every 3 weeks (Q3W) as 30-minute infusion intravenously (IV) from Cycle 1 (each cycle is 21 days) to Cycle 6 and dostarlimab 1000 mg every 6 weeks (Q6W) (Cycle 7 until progression of disease, toxicity, withdrawal of consent, Investigator's decision, or death, whichever occurs first); followed by Carboplatin 5 mg/milliliter (mL)/minute (min) and paclitaxel 175 mg per square meter (mg/m^2) Q3W as 30-minute infusion IV from Cycle 1 to Cycle 6.
• Placebo Comparator: Placebo plus carboplatin-paclitaxel
  Participants will be administered placebo Q3W as 30-minute infusion IV from Cycle 1 to Cycle 6 and placebo Q6W (Cycle 7 until progression of disease, toxicity, withdrawal of consent, Investigator's decision, or death, whichever occurs first); followed by carboplatin 5mg/mL/min and paclitaxel 175 mg/m^2 Q3W as 30-minute infusion IV from Cycle 1 to Cycle 6.

Geprüfte Regime

• Dostarlimab (TSR-042):
  Dostarlimab is a humanized monoclonal antibody that binds with high affinity to programmed cell death-1 (PD-1) resulting in inhibition of its binding to programmed death receptor ligands 1 and 2 (PD-L1 and PD-L2).
• Placebo:
  Placebo will be available as IV dextrose solution with no active drug to mimic dostarlimab.
• Carboplatin-paclitaxel:
  Carboplatin in combination with paclitaxel is a chemotherapy treatment that has been shown to be efficacious against a variety of different tumor types.

Quelle: ClinicalTrials.gov