NRG-GY018 — Testing the Addition of the Immunotherapy Drug Pembrolizumab to the Usual Chemotherapy Treatment (Paclitaxel and Carboplatin) in Stage III-IV or Recurrent Endometrial Cancer

Phase 3 · 2023 · Endometrial Cancer

Design

Randomized, double-blind trial adding pembrolizumab or placebo to carboplatin-paclitaxel, stratified by mismatch repair (MMR) status.

Population

Measurable stage III-IV or recurrent endometrial cancer, analyzed separately in dMMR and pMMR cohorts.

Primary Endpoint

progression-free survival (PFS)

Key Result

dMMR cohort PFS HR 0.30 (median not reached vs 7.6 months); pMMR cohort PFS HR 0.54 (13.1 vs 8.7 months).

Guideline Impact

NCCN category 1 for first-line pembrolizumab plus chemotherapy in advanced endometrial cancer