Study of Adjuvant Cemiplimab Versus Placebo After Surgery and Radiation Therapy in Patients With High Risk Cutaneous Squamous Cell Carcinoma
NCT03969004Phase 3Active, not recruiting
- Lead sponsor
- Regeneron Pharmaceuticals (Industry)
- Enrollment
- 415 (actual)
- Start date
- 4 Jun 2019
- Primary completion
- 7 Jan 2028 (estimated)
- Study completion
- 7 Jan 2028
- Last update posted
- 27 Mar 2026
Design
- Study type
- Interventional
- Primary purpose
- Treatment
- Allocation
- Randomized
- Intervention model
- Parallel
- Masking
- Quadruple
- Arms
- 2
Interventions
- Cemiplimab Drug
- Placebo Drug
Conditions and primary outcome
- Cutaneous Squamous Cell Carcinoma
Primary outcome
DFS defined as time from randomization to the first documented disease recurrence (local, regional and/or distant); or death due to any cause. (Up to 54 months)
Posted results on ClinicalTrials.gov
Results posted on ClinicalTrials.gov: No
Results from company and journal sources
No editor-confirmed results are on record for this study.
Publications
1 on PubMedAdjuvant Cemiplimab or Placebo in High-Risk Cutaneous Squamous-Cell Carcinoma.
The New England journal of medicine · 2025 Aug 21
PubMed 40454639 (opens in a new tab)DOI 10.1056/NEJMoa2502449 (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
About CT-VCALoading CT-VCA scores…
Data integrity
Compare what the registry, company releases, FDA documents and publications say about this study.
Drugs on HealthTrade
Source
- NCT03969004 on ClinicalTrials.gov (opens in a new tab) Licence: public-domain. Read
Source: ClinicalTrials.gov, U.S. National Library of Medicine. Listing a study does not mean NLM has evaluated it.
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