OptimICE-pCR (A012103)
Asks whether patients whose cancer completely disappeared before surgery still need a year of immunotherapy afterwards.
De-escalation trial; if non-inferior, would spare ~60% of KEYNOTE-522 patients nine cycles of pembrolizumab. Discussed at ASCO 2026.
Setting
Stage II-III TNBC with pathologic complete response after KEYNOTE-522 regimen: adjuvant pembrolizumab vs observation
Phase
Phase 3
Sponsor
Alliance / NCI
Registry
Enrolled
1295
Replication
Ongoing de-escalation trial; no results.