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Trial result

Camrelizumab (PD-1) + cisplatin/nab-paclitaxel hits 100% ORR and 30% pCR in PD-L1–negative LACC

Trial ID
NCT06288360 on ClinicalTrials.gov
Cancer type
Cervical Cancer
Published in
DOUBLE ISSUE: New in Oncology - July 8, 2026

Camrelizumab is an anti–PD-1 antibody tested here as neoadjuvant chemo-immunotherapy (NACI) with cisplatin + nab-paclitaxel in a multicenter, open-label, single-arm Phase 2 trial in treatment-naïve, PD-L1–negative (CPS<1) locally advanced cervical cancer (FIGO 2018 IB3/IIA2/IIB/IIIC1r; tumor >4cm; NCT06288360). In the interim cohort enrolled Sep 12, 2024–Dec 12, 2025 (n=10; 9 completed NACI), ORR was 100% (9/9), R0 resection was 100% (9/9), and pCR was 30% (3/10 enrolled; 3/9 treated), with most non-pCR resections lacking Sedlis intermediate-risk features (4/6) and observed on surveillance; 2 patients had high-risk findings (parametrial invasion or nodal metastasis) and received adjuvant chemoradiotherapy. Grade ≥3 immune-related AEs were limited in this snapshot (most commonly lymphocytopenia) with no treatment-related deaths or treatment delays; clinically, pCR ~30% looks in the ballpark of historical neoadjuvant chemo surgical series in LACC (often ~15–20% pCR depending on regimen/population), while modern US standard for many LACC patients is definitive chemoradiation (increasingly with pembrolizumab in high-risk disease rather than surgery-first), so cross-trial comparisons are inherently apples-to-oranges.

Take home

If this pCR signal holds up in a full (planned) n=40—and if EFS/OS don’t erode with follow-up—it would strengthen the case that PD-L1 negativity alone shouldn’t exclude patients from neoadjuvant IO strategies, but the tiny interim sample and the fact that current SOC is shifting toward CRT±pembrolizumab means the real bar is durable outcomes (and QOL) vs contemporary CRT-based approaches.

Source: Read the original publication

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