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Checkpoint Inhibitor
Cemiplimab for Skin Cancer
Phase 2
Recruiting
Led By Gino K In, MD
Research Sponsored by University of Southern California
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Patients must have disease that is considered either: (1) high-risk localized CSCC, (2) locally recurrent CSCC, or (3) regionally advanced CSCC
Histologically confirmed, cutaneous squamous cell carcinoma
Timeline
Screening 3 weeks
Treatment Varies
Follow Up at 9 weeks
Awards & highlights
Study Summary
This trial looks at using immunotherapy with cemiplimab to treat patients with skin cancer before surgery.
Who is the study for?
This trial is for adults with high-risk, resectable skin cancer that's localized, locally recurrent, or regionally advanced. They must have measurable disease and not have had prior PD-1/PD-L1 inhibitors or immune therapies within 4 weeks. Major organ functions need to be stable, no uncontrolled illnesses are allowed, and they can't be pregnant or breastfeeding. Participants should agree to use contraception during the study.Check my eligibility
What is being tested?
The trial tests if cemiplimab given before surgery can help treat patients with certain types of skin cancer. Cemiplimab is a monoclonal antibody designed to boost the body's immune response against cancer cells by blocking the PD-1 pathway which tumors use to evade attack.See study design
What are the potential side effects?
Cemiplimab may cause fatigue, skin reactions at injection sites, diarrhea, muscle pain and weakness. It might also lead to more serious issues like inflammation in organs such as lungs (pneumonitis), liver (hepatitis), intestines (colitis) or hormone glands.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
My skin cancer is either high-risk, has come back, or has spread locally.
Select...
My skin cancer is confirmed as squamous cell carcinoma.
Select...
My CSCC has at least two high-risk features based on its size, location, growth rate, or specific cell types.
Select...
I am fully active or can carry out light work.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ at 9 weeks
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~at 9 weeks
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Confirmed pathologic partial response
Secondary outcome measures
Incidence of toxicities
Objective response rate
Pathologic complete response rate
+1 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: Treatment (cemiplimab, surgical resection)Experimental Treatment2 Interventions
Patients receive cemiplimab IV over 30 minutes on day 1. Treatment repeats every 21 days for up to 3 cycles (or up to 4 cycles for patients whose disease is unresectable after 3 cycles) in the absence of disease progression or unacceptable toxicity. Within 6 weeks of last dose of therapy, patients with potentially resectable tumors undergo surgical resection.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Resection
2021
Completed Phase 2
~410
Cemiplimab
FDA approved
Find a Location
Who is running the clinical trial?
University of Southern CaliforniaLead Sponsor
906 Previous Clinical Trials
1,596,254 Total Patients Enrolled
National Cancer Institute (NCI)NIH
13,665 Previous Clinical Trials
40,926,164 Total Patients Enrolled
Gino K In, MDPrincipal InvestigatorUniversity of Southern California
1 Previous Clinical Trials
16 Total Patients Enrolled
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- My cancer is considered possibly removable by surgery.Patients must have a disease that can be measured.I haven't taken high doses of steroids like prednisone (10 mg or more) in the last 2 weeks.You must have at least 75,000 platelets per microliter of blood.Your AST and ALT blood test results should not be more than three times the normal limit set by the hospital.I agree to use birth control or abstain from sex during and for 90 days after the study.Your absolute lymphocyte count must be at least 500 per microliter.Your creatinine level should be less than or equal to 1.8 mg/dl.I can understand and agree to sign the consent form and follow through with surgery and study requirements.I do not have any severe illnesses or social situations that would stop me from following the study's requirements.I haven't needed drugs for an autoimmune disease in the last 2 years, except for hormone replacements.I have not had major surgery in the last 2 weeks or have recovered from any complications.My skin cancer is either high-risk, has come back, or has spread locally.I have not had any cancer except for certain skin cancers, in situ cancers, or local tumors treated over 5 years ago.My skin cancer is confirmed as squamous cell carcinoma.I haven't had radiation, non-cytotoxic, or experimental treatments in the last 4 weeks.I haven't taken any immune therapy drugs in the last 4 weeks.My cancer has spread and cannot be removed by surgery, but it hasn't reached my internal organs.Your hemoglobin level is at least 8.0 grams per deciliter.I am not on any other cancer treatments while on this trial.Your total bilirubin level should be within a certain range as per the hospital's standard.My CSCC has at least two high-risk features based on its size, location, growth rate, or specific cell types.I have advanced skin cancer that might be removed by surgery.I have previously been treated with drugs targeting PD-1 or PD-L1.I have had allergic reactions to specific cancer treatments before.Your body has enough white blood cells called neutrophils.I have had a solid organ or bone marrow transplant.My skin cancer has returned after treatment but can still be removed.I am fully active or can carry out light work.
Research Study Groups:
This trial has the following groups:- Group 1: Treatment (cemiplimab, surgical resection)
Awards:
This trial has 2 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
- All Individual Drugs Already Approved - Therapies where all constituent drugs have already been approved are likely to have better-understood side effect profiles.
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.
Have any prior examinations been conducted involving Cemiplimab?
"Currently, there are 56 live trials exploring the efficacy of Cemiplimab with 4 being conducted at Phase 3. Most experiments involving this drug take place in Barcelona and California but it is tested across 1738 clinical sites worldwide."
Answered by AI
Are there any vacancies remaining in this research program?
"According to clinicaltrials.gov, recruitment for this trial is still going on; the protocol was first posted in June 2020 and recently updated in November 2022."
Answered by AI
How many participants are being accepted for this research study?
"Affirmative. The details hosted on clinicaltrials.gov demonstrate that this investigation, which was first posted in June 2020, is actively enrolling patients. 34 people must be enrolled from 3 distinct sites for the trial to proceed as planned."
Answered by AI
Has Cemiplimab garnered authorization from the Food and Drug Administration?
"Evaluation of Cemiplimab's safety is estimated to be 2 out of 3 because the Phase 2 trial provides some evidence for its security but not much in terms of therapeutic effectiveness."
Answered by AI
What medical applications is Cemiplimab routinely prescribed for?
"Cemiplimab is an effective remedy for treating alk gene mutation, creating advance directives, and reducing malignant neoplasms."
Answered by AI
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