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NCT04242173 · ClinicalTrials.gov registry record · Phase 2

Cemiplimab-rwlc for Unresectable Locally Recurrent and/or Metastatic CSCC

A Phase 2 study, sponsored by H. Lee Moffitt Cancer Center and Research Institute.

Terminated
Registry status
Phase 2
Development phase
3
Enrollment target

NCT04242173: Clinical Trial Phase 2 study, sponsored by H. Lee Moffitt Cancer Center and Research Institute.

NCT04242173 is a Phase 2 study that was terminated before completion, run by H. Lee Moffitt Cancer Center and Research Institute. The registered enrollment target is 3 participants, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (98% lower). According to ClinicalTrials.gov, the official US trial registry.

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The verdict

NCT04242173, a Phase 2 study, was terminated before completion, sponsored by H. Lee Moffitt Cancer Center and Research Institute.

TERMINATED
Registry status
Phase 2
Development phase
3 participants
Enrollment target

Study Summary

The purpose of this research study is to determine how people with weakened immune systems and unresectable (cannot be removed by surgery) locally recurrent and/or metastatic cutaneous squamous cell carcinoma (CSCC) respond to study treatment with Cemiplimab. Cemiplimab is approved for sale in United States by the U.S. Food and Drug Administration (FDA).

Primary Outcome

Overall Response Rate (ORR) as indicated by Response Evaluation Criteria in Solid Tumors (RECIST) 1.1 analysis of radiologic scans. In some patients, response assessments include photos and radiologic scans and will be evaluated by composite efficacy criteria. Clinical lesions will only be considered measurable when they are superficial (eg, skin nodules and palpable lymph nodes) and ≥10 mm (≥1 cm) diameter as assessed using calipers (e.g., skin nodules). Patients who are deemed as not evaluabl

Interventions

  • DRUG Cemiplimab-Rwlc

Trial Details

FieldValue
Enrollment Target 3 participants
Start Date 2020-06-25
Est. Completion 2022-05-26
Phase Phase 2

Why NCT04242173 stopped before completion

NCT04242173 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 3 participants, a relatively small participant target, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (98% lower).

The record links to 0 conditions, and to 1 intervention - of which Cemiplimab-Rwlc is the first listed.

NCT04242173 does not publish any study locations in the registry export this page uses.

Frequently Asked Questions

What is clinical trial NCT04242173 about?

NCT04242173 is a clinical study titled "Cemiplimab-rwlc for Unresectable Locally Recurrent and/or Metastatic CSCC". The purpose of this research study is to determine how people with weakened immune systems and unresectable (cannot be removed by surgery) locally recurrent and/or metastatic cutaneous squamous cell carcinoma (CSCC) respond to study treatment with Cemiplimab. Cemiplimab is approved for sale in Unite...

What is the current status of trial NCT04242173?

This trial is currently terminated. It is a Phase 2 study. The enrollment target is 3 participants. The study started on 2020-06-25. Estimated completion is 2022-05-26.

What interventions are being tested in trial NCT04242173?

The interventions under investigation include: Cemiplimab-Rwlc (DRUG).

Who is sponsoring clinical trial NCT04242173?

This trial is sponsored by H. Lee Moffitt Cancer Center and Research Institute, which has 502 total clinical trials registered on ClinicalTrials.gov.

How this trial's enrollment target compares

Where NCT04242173's enrollment target sits among peer trials

3 2001st of 2000 the lowest of 2,000 other Phase 2 trials

participants (enrollment target), bucketed by value

Each bar is a band; taller bars hold more other Phase 2 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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Source: ClinicalTrials.gov NCT04242173, the US trial registry maintained by the National Library of Medicine. NCT04242173 (small enrollment · none site footprint · terminated) retrieved and formatted by PlainTrial, see methodology.