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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 52 months

Awards & highlights

Study 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.Check my eligibility

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.See study design

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

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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.

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I am fully active or can carry out light work.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ up to 52 months

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~up to 52 months

This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 52 months for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

Number of Participants With Pathologic Complete Response (pCR) as Assessed by Independent Central Pathology Review

Secondary outcome measures

Disease Free Survival (DFS)

Event Free Survival (EFS)

Incidence of Adverse Events (AEs)

+10 more

Side effects data

From 2023 Phase 3 trial • 608 Patients • NCT03257267

25%

Anaemia

20%

Nausea

17%

Fatigue

16%

Vomiting

15%

Decreased appetite

15%

Constipation

11%

Asthenia

11%

Back pain

11%

Pyrexia

11%

Diarrhoea

10%

Arthralgia

Urinary tract infection

Dyspnoea

Abdominal pain

Cough

Oedema peripheral

Hypoalbuminaemia

Headache

Pain in extremity

Rash

Blood creatinine increased

Insomnia

Hypokalaemia

Hypothyroidism

Pruritus

Vaginal haemorrhage

Alanine aminotransferase increased

Aspartate aminotransferase increased

Pelvic pain

Stomatitis

Neutropenia

Acute kidney injury

Immune-mediated hepatitis

Autoimmune hepatitis

Febrile neutropenia

Pneumonia

Pyelonephritis

Thrombocytopenia

Neutrophil count decreased

Pyelonephritis acute

White blood cell count decreased

Sepsis

Duodenal ulcer

Haematuria

Hydronephrosis

Hyperpyrexia

Kidney infection

Pneumonitis

Hyperglycaemia

100%

80%

60%

40%

20%

Study treatment Arm

Cemiplimab

Investigator Choice (IC) Chemotherapy

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

~1340

0 / 2Eligibility criteria met

Find a Location

Who is running the clinical trial?

Regeneron PharmaceuticalsLead Sponsor

624 Previous Clinical Trials

381,594 Total Patients Enrolled

SanofiIndustry Sponsor

2,165 Previous Clinical Trials

3,515,223 Total Patients Enrolled

Clinical Trial ManagementStudy DirectorRegeneron Pharmaceuticals

264 Previous Clinical Trials

252,127 Total Patients Enrolled

Media Library

Cemiplimab (PD-1 Inhibitor) Clinical Trial Eligibility Overview. Trial Name: NCT04154943 — Phase 2

Squamous Cell Carcinoma Research Study Groups: Cemiplimab

Squamous Cell Carcinoma 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

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Do we have any previous research to fall back on regarding Cemiplimab?

"Cemiplimab was first researched in 2010 at City of Hope. In the decade since, there have been 6 other completed clinical trials. As of right now, 59 active studies are being conducted; a majority of these taking place in Miami, Florida."

Answered by AI

Are investigators still enrolling new participants in this research?

"This specific trial is no longer enrolling patients, as seen by the latest update on clinicaltrials.gov from April 5th, 2022. If you are looking for other trials, there are 2669 studies actively recruiting participants with carcinoma, squamous cell and 59 studies for Cemiplimab that still need volunteers."

Answered by AI

What have been reported as adverse effects of Cemiplimab?

"Cemiplimab is a Phase 2 medication, meaning that while there is some evidence of its safety, there is none for its efficacy. Therefore, our team has given it a score of 2."

Answered by AI

What are the conditions that Cemiplimab is approved to treat?

"Cemiplimab is a medication used to target the alk gene mutation. It can also be taken as part of treatment for various conditions such as advance directives, malignant neoplasms, metastatic cutaneous squamous cell carcinoma."

Answered by AI

How many people have been approved to participate in this trial?

"Unfortunately, this particular clinical trial is not recruiting patients at the moment. According to information found on clinicaltrials.gov, this study was first posted on March 10th, 2020 and last updated on April 5th, 2022. However, there are 2669 trials for carcinoma, squamous cell and 59 Cemiplimab trials that are actively looking for patients if you're interested in participating in other studies."

Answered by AI

How many research institutes are coordinating this clinical trial?

"Currently, this trial is operational at 14 sites. These locations include Miami, Baltimore, Palo Alto and 11 other places. If you are considering enrolling in this trial, please choose the site closest to your residence to minimize travel."

Answered by AI

Recent research and studies

New England Journal of MedicineJournal

Neoadjuvant Cemiplimab for Stage II to IV Cutaneous Squamous-cell Carcinoma

Gross, Neil D., David M. Miller, Nikhil I. Khushalani, Vasu Divi, Emily S. Ruiz, Evan J. Lipson, Friedegund Meier, et al.. 2022. “Neoadjuvant Cemiplimab for Stage II to IV Cutaneous Squamous-cell Carcinoma”. New England Journal of Medicine. Massachusetts Medical Society. doi:10.1056/nejmoa2209813.

clinicaltrials.govStudy

Study of Cemiplimab in Patients With Type of Skin Cancer Stage II to IV Cutaneous Squamous Cell Carcinoma

2020. "Study of Cemiplimab in Patients With Type of Skin Cancer Stage II to IV Cutaneous Squamous Cell Carcinoma". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT04154943.

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