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NCT03257267 · ClinicalTrials.gov registry record · Phase 3
Study of Cemiplimab in Adults With Cervical Cancer
A Phase 3 study, sponsored by Regeneron Pharmaceuticals.
- Completed
- Registry status
- Phase 3
- Development phase
- 608
- Enrollment target
NCT03257267: Completed Phase 3 study, sponsored by Regeneron Pharmaceuticals.
NCT03257267 is a Phase 3 study that has completed, run by Regeneron Pharmaceuticals. The registered enrollment target is 608 participants, below the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (21% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT03257267, a Phase 3 study, has completed, sponsored by Regeneron Pharmaceuticals.
- COMPLETED
- Registry status
- Phase 3
- Development phase
- 608 participants
- Enrollment target
Study Summary
The primary objective is to compare overall survival (OS) for patients with recurrent or metastatic cervical cancer who have histology of squamous cell carcinoma (SCC) and who have any eligible histology treated with either cemiplimab or investigator's choice (IC) chemotherapy. The secondary objectives performed among SCC patients and among all eligible histologies (SCC and adenocarcinoma/adenosquamous carcinoma (AC) are: * To compare progression-free survival (PFS) of cemiplimab versus IC chemotherapy * To compare objective response rate (ORR) (partial response \[PR\] + complete response \[CR\]) of cemiplimab versus IC chemotherapy per Response Evaluation Criteria in Solid Tumors (RECIST) 1.1 * To compare the duration of response (DOR) of cemiplimab versus IC chemotherapy * To compare the safety profiles of cemiplimab versus IC chemotherapy by describing adverse events (AE) * To compare quality of life (QOL) for patients treated with cemiplimab versus IC chemotherapy using the European Organization for Research and Treatment of Cancer Quality of Life Questionnaire-Core 30 (EORTC QLQ-C30)
Primary Outcome
Overall survival was defined as the time from randomization to the date of death due to any cause. A participant who had not died was censored at the last known date of contact.
Interventions
- DRUG Cemiplimab
- DRUG Investigator Choice (IC) Chemotherapy
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 608 participants |
| Start Date | 2017-09-05 |
| Est. Completion | 2023-04-20 |
| Phase | Phase 3 |
What the finished NCT03257267 record still lists
NCT03257267 is an interventional study that assigns participants to a tested intervention. The registered 608 participants enrollment target is mid-sized for trials with a published cap, below the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (21% lower).
The record links to 0 conditions, and to 2 interventions - of which Cemiplimab is the first listed.
NCT03257267 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT03257267 about?
NCT03257267 is a clinical study titled "Study of Cemiplimab in Adults With Cervical Cancer". The primary objective is to compare overall survival (OS) for patients with recurrent or metastatic cervical cancer who have histology of squamous cell carcinoma (SCC) and who have any eligible histology treated with either cemiplimab or investigator's choice (IC) chemotherapy. The secondary object...
What is the current status of trial NCT03257267?
This trial is currently completed. It is a Phase 3 study. The enrollment target is 608 participants. The study started on 2017-09-05. Estimated completion is 2023-04-20.
What interventions are being tested in trial NCT03257267?
The interventions under investigation include: Cemiplimab (DRUG), Investigator Choice (IC) Chemotherapy (DRUG).
Who is sponsoring clinical trial NCT03257267?
This trial is sponsored by Regeneron Pharmaceuticals, which has 280 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT03257267's enrollment target sits among peer trials
608 603rd of 2000 higher than 1,396 of 2,000 other Phase 3 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 3 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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