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The first immunotherapy to extend life in recurrent cervical cancer, approved in Europe but declined by the FDA.
EMPOWER-Cervical 1, also GOG-3016 and ENGOT-cx9, trial NCT03257267 sponsored by Regeneron and Sanofi and published in the New England Journal of Medicine in 2022, produced the first immunotherapy to extend life in recurrent cervical cancer after first-line platinum, approved in Europe but declined by the FDA. It randomised 608 patients to cemiplimab or single-agent chemotherapy and met its primary overall survival endpoint regardless of PD-L1 status or histology; the European Union approved it in 2022, but the FDA issued a complete response letter in January 2022 over inspection issues and the application was not resubmitted. OnCo links it to cervical cancer, PD-1 as a target, cemiplimab, Regeneron and Sanofi. It has been largely superseded by first-line chemo-immunotherapy, and whether single-agent PD-1 blockade retains a second-line role after that is the open question.
Numbers are from the trial as recorded here; see the source links in the table below. This is orientation, not medical advice: ask your team how closely the trial population matches you.
The full inclusion and exclusion criteria are on the registry record. Read 2026-10-07. Recruiting overall does not mean a particular site is open; ask the study team.
ClinicalTrials.gov data courtesy of the US National Library of Medicine.
Shares EMPOWER-Cervical 1: cemiplimab versus chemotherapy in recurrent cervical cancer after platinum, Recurrent or metastatic cervical cancer, Cervical cancer.
Shares Regeneron, Cemiplimab, Immune checkpoint inhibitors.
Shares Regeneron, Cemiplimab, Immune checkpoint inhibitors.
Shares Regeneron, Cemiplimab, Immune checkpoint inhibitors.
Shares Regeneron, Cemiplimab, Immune checkpoint inhibitors.
Shares Regeneron, Cemiplimab, Immune checkpoint inhibitors.
Shares Regeneron, Cemiplimab, Immune checkpoint inhibitors.
Shares Recurrent or metastatic cervical cancer, Cervical cancer, Immune checkpoint inhibitors.
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