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NCT04913220 · ClinicalTrials.gov registry record · Phase 1
A Study of SAR444245 Combined With Cemiplimab for the Treatment of Participants With Various Advanced Skin Cancers (Pegathor Skin 201)
A Phase 1 study, sponsored by Sanofi.
- Terminated
- Registry status
- Phase 1
- Development phase
- 46
- Enrollment target
NCT04913220: Clinical Trial Phase 1 study, sponsored by Sanofi.
NCT04913220 is a Phase 1 study that was terminated before completion, run by Sanofi. The registered enrollment target is 46 participants, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (23% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT04913220, a Phase 1 study, was terminated before completion, sponsored by Sanofi.
- TERMINATED
- Registry status
- Phase 1
- Development phase
- 46 participants
- Enrollment target
Study Summary
Primary Objective: -To determine the antitumor activity of SAR444245 in combination with cemiplimab. Secondary Objectives: * To determine the recommended phase 2 dose and to assess the safety profile of SAR444245 when combined with cemiplimab * To assess other indicators of antitumor activity * To assess the concentrations of SAR444245 when given in combination with cemiplimab * To assess the immunogenicity of SAR444245 * To assess active concentrations of cemiplimab when given in combination with SAR444245
Primary Outcome
The ORR was defined as the percentage of participants who had best overall response (BOR) as confirmed complete response (CR) or partial response (PR) as per Response Evaluation Criteria in Solid Tumors (RECIST) version (v) 1.1 or modified world health organization (WHO) response criteria. CR was defined as the disappearance of all target lesions, any pathological lymph nodes (whether target or non-target) with reduction in short axis to \<10 millimeter (mm) (\<1 centimeter \[cm\]). PR was defin
Interventions
- DRUG Cemiplimab
- DRUG THOR-707
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 46 participants |
| Start Date | 2021-07-15 |
| Est. Completion | 2025-02-18 |
| Phase | Phase 1 |
Why NCT04913220 stopped before completion
NCT04913220 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 46 participants, a relatively small participant target, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (23% lower).
The record links to 0 conditions, and to 2 interventions - of which Cemiplimab is the first listed.
NCT04913220 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT04913220 about?
NCT04913220 is a clinical study titled "A Study of SAR444245 Combined With Cemiplimab for the Treatment of Participants With Various Advanced Skin Cancers (Pegathor Skin 201)". Primary Objective: -To determine the antitumor activity of SAR444245 in combination with cemiplimab. Secondary Objectives: * To determine the recommended phase 2 dose and to assess the safety profile of SAR444245 when combined with cemiplimab * To assess other indicators of antitumor activity * T...
What is the current status of trial NCT04913220?
This trial is currently terminated. It is a Phase 1 study. The enrollment target is 46 participants. The study started on 2021-07-15. Estimated completion is 2025-02-18.
What interventions are being tested in trial NCT04913220?
The interventions under investigation include: Cemiplimab (DRUG), THOR-707 (DRUG).
Who is sponsoring clinical trial NCT04913220?
This trial is sponsored by Sanofi, which has 713 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT04913220's enrollment target sits among peer trials
46 1058th of 2000 higher than 935 of 2,000 other Phase 1 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 1 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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