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Adjuvant Cemiplimab for Squamous Cell Carcinoma

Phase 3
Recruiting
Research Sponsored by Regeneron Pharmaceuticals
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
High risk CSCC, as defined in the protocol
Adequate hepatic, renal, and bone marrow function as defined in the protocol
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to 78 months
Awards & highlights

Study Summary

This trial is testing if a drug called cemiplimab can help people with high-risk cutaneous squamous cell carcinoma (CSCC) live longer without their cancer coming back.

Who is the study for?
This trial is for adults with high-risk cutaneous squamous cell carcinoma (CSCC) who've had surgery and radiation. They should be in good physical condition, have no other cancers or significant autoimmune diseases, and their major organs must function well.Check my eligibility
What is being tested?
The study tests if Cemiplimab improves disease-free survival compared to a placebo in patients with CSCC after surgery and radiation. It also looks at overall survival, local/regional recurrence, distant recurrence, second primary tumors, safety of the drug, and its effects on the body.See study design
What are the potential side effects?
Potential side effects of Cemiplimab may include immune-related reactions due to it being an immunotherapy drug. These can range from mild skin conditions to more serious organ inflammation.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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My skin cancer is considered high risk.
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My liver, kidneys, and bone marrow are working well.
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I am 21 years old or older and live in Japan.
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I am fully active and can carry on all pre-disease activities without restriction.
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I finished my radiation therapy aimed at curing my cancer between 2 to 10 weeks ago.
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I had surgery to remove skin cancer that was confirmed by a lab test.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to 78 months
This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 78 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
DFS defined as time from randomization to the first documented disease recurrence (local, regional and/or distant); or death due to any cause.
Secondary outcome measures
Anti-drug antibodies (ADA) in serum
Cemiplimab concentrations in serum
Cumulative occurrence of second primary cutaneous squamous cell carcinoma tumor (SPTs) for each patient from randomization to occurrence of first primary endpoint event or end of study.
+6 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
9%
Urinary tract infection
9%
Dyspnoea
9%
Abdominal pain
7%
Cough
7%
Oedema peripheral
7%
Hypoalbuminaemia
7%
Headache
6%
Pain in extremity
6%
Rash
6%
Blood creatinine increased
6%
Insomnia
6%
Hypokalaemia
6%
Hypothyroidism
5%
Pruritus
5%
Vaginal haemorrhage
4%
Alanine aminotransferase increased
4%
Aspartate aminotransferase increased
4%
Pelvic pain
4%
Stomatitis
3%
Neutropenia
2%
Acute kidney injury
1%
Febrile neutropenia
1%
Pneumonia
1%
Pyelonephritis
1%
Autoimmune hepatitis
1%
Immune-mediated hepatitis
1%
Thrombocytopenia
1%
Neutrophil count decreased
1%
Pyelonephritis acute
1%
White blood cell count decreased
1%
Sepsis
1%
Duodenal ulcer
1%
Haematuria
1%
Hydronephrosis
1%
Hyperpyrexia
1%
Kidney infection
1%
Pneumonitis
1%
Hyperglycaemia
100%
80%
60%
40%
20%
0%
Study treatment Arm
Cemiplimab
Investigator Choice (IC) Chemotherapy

Trial Design

2Treatment groups
Experimental Treatment
Placebo Group
Group I: CemiplimabExperimental Treatment1 Intervention
Group II: PlaceboPlacebo Group1 Intervention
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Cemiplimab
2015
Completed Phase 3
~1340

Find a Location

Who is running the clinical trial?

Regeneron PharmaceuticalsLead Sponsor
613 Previous Clinical Trials
379,346 Total Patients Enrolled
SanofiIndustry Sponsor
2,160 Previous Clinical Trials
3,511,605 Total Patients Enrolled
Clinical Trial ManagementStudy DirectorRegeneron Pharmaceuticals
258 Previous Clinical Trials
250,586 Total Patients Enrolled

Frequently Asked Questions

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

What are the standard procedures for Cemiplimab patients?

"Cemiplimab is used to treat alk gene mutation and several other conditions, such as malignant neoplasms, metastatic cutaneous squamous cell carcinoma, and advance directives."

Answered by AI

Are there other ongoing studies testing Cemiplimab's efficacy?

"At present, there are 60 Cemiplimab clinical trials underway. 4 of these trials are in their final stage of research (Phase 3). The majority of these studies are based in Barcelona and California; though, there are 1,819 locations worldwide conducting research for this medication."

Answered by AI

Is this research being conducted simultaneously across different states?

"The primary locations for this study are Dana Farber/Harvard Cancer Center in Boston, Massachusetts, Sarah Cannon Research Institute - Tennessee Oncology in Nashville, Tennessee, and University of Pennsylvania in Basking Ridge, New jersey. However, there are 61 other sites where this trial is also taking place."

Answered by AI

Has the FDA cleared cemiplimab for public use?

"Cemiplimab's safety is based on multiple rounds of data collection, with some efficacy data supporting it. Therefore, it received a score of 3."

Answered by AI

How many people suffering from this condition can take part in this research?

"The pharmaceutical company sponsoring this clinical trial, Sanofi, needs a total of 412 eligible patients to participate. The study will be conducted across various sites, such as Dana Farber/Harvard Cancer Center in Boston, Massachusetts and Sarah Cannon Research Institute - Tennessee Oncology in Nashville, Tennessee."

Answered by AI

Are there still empty slots where people can enroll in this clinical trial?

"The most recent update on clinicaltrials.gov shows that this trial is still enrolling patients. This clinical trial was posted on 6/4/2019."

Answered by AI
~124 spots leftby May 2026