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NCT03836105 · ClinicalTrials.gov registry record
CemiplimAb Survivorship Epidemiology
A clinical trial, sponsored by Regeneron Pharmaceuticals.
- Completed
- Registry status
- 287
- Enrollment target
NCT03836105: Completed study, sponsored by Regeneron Pharmaceuticals.
NCT03836105 is a clinical trial that has completed, run by Regeneron Pharmaceuticals. The registered enrollment target is 287 participants. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT03836105 has completed, sponsored by Regeneron Pharmaceuticals.
- COMPLETED
- Registry status
- 287 participants
- Enrollment target
Study Summary
The objectives of the study are: * To describe the effectiveness of cemiplimab 350 mg administered every 3 weeks (Q3W) for treatment of patients with advanced (defined as locally advanced or metastatic \[nodal or distant\]) cutaneous squamous cell carcinoma (CSCC) and patients with advanced (defined as locally advanced or metastatic \[nodal or distant\]) basal cell carcinoma (BCC) in real-world clinical settings * To evaluate the safety of cemiplimab based on incidence of treatment related immune-related adverse events (irAEs), infusion related reactions (IRRs), and treatment related serious adverse reactions (TSARs) in patients with advanced CSCC and patients with advanced BCC receiving cemiplimab treatment in real world clinical settings * To describe patient experience, including patient reported quality of life (QOL) and functional status, and clinician reported performance status in a real-world setting for patients with advanced CSCC and patients with advanced BCC * To describe baseline characteristics that could potentially be associated with health-related outcomes for patients with advanced CSCC and patients with advanced BCC undergoing treatment with cemiplimab * To describe patients who receive cemiplimab as treatment for CSCC or BCC in a real-world setting * To describe real-world use patterns of cemiplimab for CSCC and BCC * To investigate the long-term effects and effectiveness of cemiplimab in patients with advanced CSCC or advanced BCC * To describe the effectiveness of cemiplimab in immunosuppressed and immunocompetent patients with advanced CSCC or advanced BCC, regardless of etiology, per available data * To describe the effectiveness of cemiplimab after prior exposure to radiation therapy for CSCC per available data * To describe the effectiveness of cemiplimab as a first-line (1L) or later systemic treatment in patients with advanced CSCC, regardless of etiology, per available data * To describe the effectiveness of cemiplimab in patients with
Primary Outcome
The rate of complete responses (CR) or partial responses (PR), as assessed by investigators
Interventions
- DRUG cemiplimab
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 287 participants |
| Start Date | 2019-06-27 |
| Est. Completion | 2025-09-29 |
What the finished NCT03836105 record still lists
NCT03836105 is an observational study that tracks outcomes without assigning an intervention. The registered 287 participants enrollment target is mid-sized for trials with a published cap.
The record links to 0 conditions, and to 1 intervention - of which cemiplimab is the first listed.
NCT03836105 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT03836105 about?
NCT03836105 is a clinical study titled "CemiplimAb Survivorship Epidemiology". The objectives of the study are: * To describe the effectiveness of cemiplimab 350 mg administered every 3 weeks (Q3W) for treatment of patients with advanced (defined as locally advanced or metastatic \[nodal or distant\]) cutaneous squamous cell carcinoma (CSCC) and patients with advanced (define...
What is the current status of trial NCT03836105?
This trial is currently completed. The enrollment target is 287 participants. The study started on 2019-06-27. Estimated completion is 2025-09-29.
What interventions are being tested in trial NCT03836105?
The interventions under investigation include: cemiplimab (DRUG).
Who is sponsoring clinical trial NCT03836105?
This trial is sponsored by Regeneron Pharmaceuticals, which has 280 total clinical trials registered on ClinicalTrials.gov.
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