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PD-1 Inhibitor
Cemiplimab for Skin Cancer
Phase 1
Recruiting
Research Sponsored by Regeneron Pharmaceuticals
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Patient must have measurable disease in the index lesion, as defined by modified WHO criteria. Measurable disease is defined as at least one lesion that is at least 1 cm in both of the longest perpendicular diameters.
Eastern Cooperative Oncology Group (ECOG) performance status ≤1
Timeline
Screening 3 weeks
Treatment Varies
Follow Up from the first dose to 90 days after the last dose
Awards & highlights
Study Summary
This trial is testing a new cancer drug, cemiplimab, to see if it is safe and effective for treating patients with skin cancer. The study will also look at the side effects of the drug and how well it works.
Who is the study for?
Adults with Cutaneous Squamous Cell Carcinoma or Basal Cell Carcinoma that can be measured and has recurred. Participants should have good performance status (ECOG ≤1) and no other serious illnesses or recent vaccinations. Those with a history of certain cancers, immune diseases, organ transplants, or previous PD-1/PD-L1 pathway treatments are excluded.Check my eligibility
What is being tested?
The trial is testing the safety and effects of an experimental drug called cemiplimab on skin cancer tumors. It involves weekly doses for 12 weeks to see how the body reacts, what side effects occur, the impact on tumors, and how much drug stays in the blood over time.See study design
What are the potential side effects?
Potential side effects from cemiplimab may include reactions related to immune system activation such as inflammation in various organs, fatigue, possible infusion-related reactions similar to allergic responses, and changes in blood tests indicating liver or kidney issues.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
My cancer can be measured and is at least 1 cm in size.
Select...
I am fully active and can carry on all my pre-disease activities without restriction.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ at time of surgery
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~at time of surgery
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Incidence and severity of TEAEs graded according to the NCI CTCAE v5
Incidence, nature, and severity of dose limiting toxicities (DLTs) (if any) graded according to the National Cancer Institute-Common Terminology Criteria for Adverse Events (NCI CTCAE) v5
Incidence, nature, and severity of treatment-emergent adverse events (TEAEs) graded according to the National Cancer Institute-Common Terminology Criteria for Adverse Events (NCI CTCAE) v5
+1 moreSecondary outcome measures
Cemiplimab concentration in serum over time
Incidence of anti-drug antibody (ADA) titers for cemiplimab
Major pathologic response rate (or end of treatment biopsies, for patients who decline surgery) in index lesion
+3 moreSide effects data
From 2023 Phase 3 trial • 608 Patients • NCT0325726725%
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%
Immune-mediated hepatitis
1%
Autoimmune hepatitis
1%
Febrile neutropenia
1%
Pneumonia
1%
Pyelonephritis
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
1Treatment groups
Experimental Treatment
Group I: CemiplimabExperimental Treatment1 Intervention
Three dose cohorts are planned and will follow a 3 + 3 dose-escalation design with cohort expansion. After completion of the above, three additional cohorts (A, B and C) of patients will be evaluated. Cohorts D, H and I may open after completion of Cohort B.
Note: Cohort E through G will not be opened for participation.
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
620 Previous Clinical Trials
380,272 Total Patients Enrolled
SanofiIndustry Sponsor
2,164 Previous Clinical Trials
3,514,867 Total Patients Enrolled
Clinical Trial ManagementStudy DirectorRegeneron Pharmaceuticals
262 Previous Clinical Trials
251,081 Total Patients Enrolled
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- My skin cancer has spread to nearby lymph nodes but not elsewhere, and if it had, I've been disease-free for 3 years.I have been treated with drugs that target the PD-1/PD-L1 pathway.My cancer can be measured and is at least 1 cm in size.I have an autoimmune disease treated with immunosuppressants in the last 5 years.I have had skin cancer that was removed more than once.I have been fully vaccinated for COVID-19, including the booster, within the last week.I am fully active and can carry on all my pre-disease activities without restriction.The requirements that must be met for someone to be included in the study.I do not have blood cancer or any other cancer likely to spread or be fatal.I have had a solid organ transplant.I have previously been treated with drugs that affect the immune system.I have had skin cancer removed more than once as per the study's conditions.
Research Study Groups:
This trial has the following groups:- Group 1: Cemiplimab
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Has Cemiplimab gained the stamp of approval from the FDA?
"As this is an early-stage trial, our team at Power has assigned a rating of 1 to cemiplimab's safety profile due to the limited evidence backing its efficacy and security."
Answered by AI
Is there a history of experimentation with Cemiplimab?
"First studied a decade ago, cemiplimab has been through 6 completed trials. Currently, there are 56 active investigations of the drug based primarily out of Houston, Texas."
Answered by AI
Are any Canadian healthcare facilities conducting this clinical investigation?
"Currently, 13 medical centres across the United States are hosting this clinical trial. These include sites in Houston, Fairfax and Durham plus 10 other locations - it is advised to pick a clinic that is closest to you should you choose to participate so as not to be impeded by travel necessities."
Answered by AI
In what clinical contexts is Cemiplimab commonly employed?
"Cemiplimab is a highly effective form of therapy for those with alk gene mutations, as well as other complex conditions such as advanced directives, malignant neoplasms, and metastatic cutaneous squamous cell carcinoma."
Answered by AI
Is this clinical study recruiting participants at present?
"Clinicaltrials.gov states that this clinical trial is still enrolling participants, with the initial posting taking place on April 11th 2019 and the latest update occurring July 29th 2022."
Answered by AI
How many participants are currently involved in this trial?
"Yes, the information hosted on clinicaltrials.gov confirms that this trial is seeking participants. The original posting was made on April 11th 2019 and it has since been edited as recently as July 29th 2022; 61 individuals are needed from 13 sites to take part in the study."
Answered by AI
Who else is applying?
What state do they live in?
New York
What site did they apply to?
Rochester Dermatologic Surgery
What portion of applicants met pre-screening criteria?
Met criteria
How many prior treatments have patients received?
1
How responsive is this trial?
Average response time
- < 2 Days
Typically responds via
Phone Call
Most responsive sites:
- Rochester Dermatologic Surgery: < 48 hours
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