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Study of Cemiplimab in Adults With Cervical Cancer

NCT03257267Phase 3Completed

Lead sponsor
Regeneron Pharmaceuticals (Industry)
Enrollment
608 (actual)
Start date
5 Sep 2017
Primary completion
15 Mar 2021 (actual)
Study completion
20 Apr 2023
Last update posted
8 Apr 2025

Design

Study type
Interventional
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel
Masking
None
Arms
2

Interventions

  • Cemiplimab Drug
  • Investigator Choice (IC) Chemotherapy Drug

Conditions and primary outcome

  • Squamous Cell Carcinoma (SCC)
  • Recurrent or Metastatic, Platinum-refractory Cervical Cancer

Primary outcome

Overall Survival (OS) (From first dose up to 90 following last dose (~42 months)); Overall Survival (OS) in the SCC Population (From first dose up to 90 following last dose (~42 months))

Posted results on ClinicalTrials.gov

Source: ClinicalTrials.gov results for NCT03257267 (opens in a new tab)· Licence: public-domain

First posted · Last update posted · Imported from ClinicalTrials.gov download 2026-10-25

Primary outcomes with a statistical analysis

  1. Overall Survival (OS)

    Time frame
    From first dose up to 90 following last dose (~42 months)
    Measure
    Median
    Unit
    Months

    • Cemiplimab vs Investigator Choice (IC) ChemotherapySuperiority

      Estimate
      0.665Hazard Ratio (HR)
      95% CI, two-sided
      0.555 to 0.796
      p-value
      <0.00001
      Method
      Stratified Log-rank Test

  2. Overall Survival (OS) in the SCC Population

    Time frame
    From first dose up to 90 following last dose (~42 months)
    Measure
    Median
    Unit
    Months

    • Cemiplimab vs Investigator Choice (IC) ChemotherapySuperiority

      Estimate
      0.698Hazard Ratio (HR)
      95% CI, two-sided
      0.570 to 0.855
      p-value
      0.00024
      Method
      Stratified Log-rank Test

Serious adverse events

Time frame: From first dose up to 90 following last dose (~42 months)

Participants with serious adverse events per group for NCT03257267, as posted
GroupAffectedAt risk
Cemiplimab100300
Chemotherapy*84290
Chemotherapy to Cemiplimab*18

Posted results as ClinicalTrials.gov prints them: primary outcome analyses and serious adverse event totals only. Registry facts, not reviewed by HealthTrade and not investment advice; filing-derived results are listed separately.

Source: ClinicalTrials.gov, U.S. National Library of Medicine. Listing a study does not mean NLM has evaluated it.

Results from company and journal sources

No editor-confirmed results are on record for this study.

Publications

2 on PubMed

  1. EMPOWER CERVICAL-1: Effects of cemiplimab versus chemotherapy on patient-reported quality of life, functioning and symptoms among women with recurrent cervical cancer.

    European journal of cancer (Oxford, England : 1990) · 2022 Oct

    PubMed 35922251 (opens in a new tab)DOI 10.1016/j.ejca.2022.03.016 (opens in a new tab)

  2. Survival with Cemiplimab in Recurrent Cervical Cancer.

    The New England journal of medicine · 2022 Feb 10

    PubMed 35139273 (opens in a new tab)DOI 10.1056/NEJMoa2112187 (opens in a new tab)

Citations from PubMed, U.S. National Library of Medicine; abstracts are not stored. A publication lists this study’s NCT number and may be a review that cites many studies.

CT-VCA trial quality

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Data integrity

Compare what the registry, company releases, FDA documents and publications say about this study.

Drugs on HealthTrade

Source

Source: ClinicalTrials.gov, U.S. National Library of Medicine. Listing a study does not mean NLM has evaluated it.

Nothing on this page is medical or investment advice.