Randomized Phase II Trial of Consolidation Pembrolizumab After Definitive Chemoradiotherapy in Locally Advanced Nasopharyngeal Carcinoma: KCSG HN19-09, CONPELAN Study
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Updated: May 23, 2026
Intramucosal Inoculation of Squamous Cell Carcinoma Cells in Mice for Tumor Immune Profiling and Treatment Response Assessment
Published on: April 22, 2019
Sang Hoon Chun1, Seyoung Seo2, Jang Ho Cho3
1Division of Medical Oncology, Department of Internal Medicine, Bucheon St. Mary's Hospital, The Catholic University of Korea, Seoul, Republic of Korea.
Background:
The benefit of consolidation programmed cell death protein 1 (PD-1) blockade after chemoradiotherapy in locoregionally advanced nasopharyngeal carcinoma (NPC) remains unclear.
Methods:
Patients with stages II-IVB NPC were randomized (2:1) to pembrolizumab 200 mg or placebo every 3 weeks for up to 17 cycles after chemoradiotherapy. The primary endpoint was 3-year progression-free survival (PFS).
Results:
Fifty-three patients were randomized (pembrolizumab, n = 34; placebo, n = 19). The 3-year PFS rates were 56.5% and 57.8% in the pembrolizumab and placebo arms, respectively (one-sided p = 0.142; stratified HR, 0.408). Grade 3 or higher adverse events occurred only in the pembrolizumab arm (8.8%). In an exploratory analysis (n = 40), high intratumoral TIL density was associated with reduced recurrence in the pembrolizumab arm (OR, 0.04; p = 0.010) but not the placebo arm.
Conclusions:
Consolidation pembrolizumab did not improve PFS in unselected locally advanced NPC. Exploratory immune profiling suggested a predictive signal warranting prospective validation.
