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Monoclonal Antibodies
Cemiplimab for Basal Cell Carcinoma
Phase 2
Recruiting
Led By Joseph Curry, MD
Research Sponsored by Thomas Jefferson University
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to 6 months post surgery (up to day 309 +/- 3 days)
Awards & highlights
Study Summary
This trial tests if cemiplimab can shrink tumors before surgery, making it easier to remove.
Who is the study for?
Adults with advanced basal cell carcinoma in the head and neck area, who need significant surgery. They should be generally healthy with a life expectancy of at least 6 months, have normal organ function tests, and not be pregnant or breastfeeding. Participants must agree to use effective contraception and cannot have had certain cancer treatments before.Check my eligibility
What is being tested?
The trial is testing Cemiplimab's effectiveness when given before surgery for shrinking tumors in patients with locally advanced basal cell carcinoma of the head and neck. It's a phase II study where all participants receive Cemiplimab along with pre-surgery evaluations like CT scans.See study design
What are the potential side effects?
Cemiplimab may cause immune-related side effects such as inflammation in various organs, skin reactions, fatigue, potential hormonal gland problems, digestive issues, and could increase infection risk.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ 6 months post-surgery (up to day 309 +/- 3 days)
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~6 months post-surgery (up to day 309 +/- 3 days)
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Disease control rate (DCR)
Objective response rate (ORR)
Secondary outcome measures
Changes in quality of life and functional organ preservation (FACE-Q)
Changes in quality of life and functional organ preservation (FHNSI)
Changes in quality of life and functional organ preservation (VFQ-25)
+4 moreTrial Design
1Treatment groups
Experimental Treatment
Group I: Treatment (cemiplimab)Experimental Treatment4 Interventions
Patients receive cemiplimab IV on study. Patients undergo CT scans and collection of blood samples throughout the trial.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Biospecimen Collection
2004
Completed Phase 2
~1700
Computed Tomography
2017
Completed Phase 2
~2720
Cemiplimab
2015
Completed Phase 3
~1340
Find a Location
Who is running the clinical trial?
Thomas Jefferson UniversityLead Sponsor
445 Previous Clinical Trials
145,404 Total Patients Enrolled
Joseph Curry, MDPrincipal InvestigatorThomas Jefferson University
4 Previous Clinical Trials
108 Total Patients Enrolled
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- My cancer affects specific parts of my body.I have had pneumonitis in the last 5 years.My skin cancer on my head or neck needs surgery.I am 18 years old or older.I am fully active or can carry out light work.I am not pregnant and will use birth control.I do not have active infections like TB, hepatitis B, C, or HIV.I have had radiation therapy for my cancer within the last 6 months.I have not received a live vaccine in the last 30 days.I have lasting side effects from cancer treatment that are moderate to severe.I have been diagnosed with a significant connective tissue disorder.I have brain metastasis that has not been treated.I am allergic to one or more components of the study drug.I am a man who can father a child and will use birth control.I am on steroids or immunosuppressants for my condition.I have other cancers, but they may be exceptions.I have received immunotherapy or hedgehog inhibitor for cancer.I do not have any unmanaged ongoing illnesses.
Research Study Groups:
This trial has the following groups:- Group 1: Treatment (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.
What are the key goals of this clinical research project?
"The purpose of this trial, to be measured over a period of up to 6 months post-operation, is measuring the Disease Control Rate (DCR). Additionally, this experiment aims at assessing Pathologic Complete Response (pCR), Major Pathologic Response (mPR) and Incidence of Adverse Events."
Answered by AI
Are there any individuals eligible to join this clinical experiment?
"The trial information posted on clinicaltrials.gov suggests that this study is no longer accepting candidates, as the last update was issued on June 28th 2023. However, there are presently 2507 other medical trials actively recruiting patients for their research projects."
Answered by AI
Has the federal government sanctioned cemiplimab for clinical use?
"Our team at Power has evaluated the safety of cemiplimab to be a 2; as this is only a Phase 2 trial, there are some data points indicating its security but no supporting evidence for effectiveness."
Answered by AI
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