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PD-1 Inhibitor

Cemiplimab for Skin Cancer

Phase 2
Waitlist Available
Research Sponsored by Regeneron Pharmaceuticals
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Stage II to IV (M0) CSCC, for which surgery would be recommended in routine clinical practice. For stage II patients, lesion must be ≥3 cm at the longest diameter.
Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to 5 years
Awards & highlights
No Placebo-Only Group

Summary

This trial is testing whether a certain drug can shrink tumors before surgery and whether it is safe.

Who is the study for?
This trial is for individuals with Stage II to IV cutaneous squamous cell carcinoma (CSCC), a type of skin cancer, who are recommended for surgery. Participants must have at least one lesion larger than 3 cm and be in good physical condition with proper organ and bone marrow function.
What is being tested?
The study tests the effectiveness of Cemiplimab before surgery (neoadjuvant therapy) by looking at how many patients achieve complete disappearance of their cancer as judged by independent review. It also examines other disease responses, survival rates, safety profile, and changes in surgical plans.
What are the potential side effects?
While not specified here, Cemiplimab can typically cause side effects like fatigue, rash, diarrhea, muscle or joint pain. Serious side effects may include immune system problems that can affect organs such as lungs or intestines.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
Select...
My skin cancer is at a stage where surgery is advised, and if it's stage II, the lesion is at least 3 cm big.
Select...
I am fully active or can carry out light work.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to 5 years
This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 5 years for reporting.

Treatment Details

Side effects data

From 2023 Phase 3 trial • 608 Patients • NCT03257267
25%
Pyrexia
13%
Subcutaneous abscess
13%
Diarrhoea
13%
Hyperthyroidism
13%
Nausea
13%
Constipation
13%
Infusion related reaction
13%
Vomiting
100%
80%
60%
40%
20%
0%
Study treatment Arm
Chemotherapy to Cemiplimab*
Cemiplimab
Chemotherapy*

Awards & Highlights

No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.

Trial Design

1Treatment groups
Experimental Treatment
Group I: CemiplimabExperimental Treatment1 Intervention
Will receive IV infusion Q3W
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Cemiplimab
2015
Completed Phase 3
~1470

Find a Location

Who is running the clinical trial?

Regeneron PharmaceuticalsLead Sponsor
668 Previous Clinical Trials
385,994 Total Patients Enrolled
SanofiIndustry Sponsor
2,204 Previous Clinical Trials
4,036,699 Total Patients Enrolled
Clinical Trial ManagementStudy DirectorRegeneron Pharmaceuticals
283 Previous Clinical Trials
255,003 Total Patients Enrolled

Media Library

Cemiplimab (PD-1 Inhibitor) Clinical Trial Eligibility Overview. Trial Name: NCT04154943 — Phase 2
Skin Cancer Research Study Groups: Cemiplimab
Skin Cancer Clinical Trial 2023: Cemiplimab Highlights & Side Effects. Trial Name: NCT04154943 — Phase 2
Cemiplimab (PD-1 Inhibitor) 2023 Treatment Timeline for Medical Study. Trial Name: NCT04154943 — Phase 2
~14 spots leftby Nov 2025
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