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Monoclonal Antibodies

Cemiplimab with Surgery for High-Risk Skin Cancer

Phase 1
Recruiting
Led By Ragini R Kudchadkar
Research Sponsored by Emory University
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Cancer confirmed to be surgically resectable, with surgery evaluation planned prior to resection
Serum creatinine =< 1.5 x ULN (or calculated creatinine clearance of >= 50 mL/min)
Timeline
Screening 3 weeks
Treatment Varies
Follow Up from baseline up to 10 years post-treatment
Awards & highlights

Study Summary

This trial will study how well cemiplimab works in treating patients with high risk cutaneous squamous cell cancer before and after surgery.

Who is the study for?
This trial is for adults with high risk cutaneous squamous cell cancer that can be removed by surgery. They must have certain blood and organ function levels, no severe allergies to monoclonal antibodies, not be pregnant or breastfeeding, and agree to use contraception. People who've had recent immunosuppressants, organ transplants, uncontrolled illnesses like heart failure or HIV on treatment are excluded.Check my eligibility
What is being tested?
The study tests if cemiplimab given before and after surgery can prevent the return of high risk skin cancer. Cemiplimab is an immune therapy drug designed to help the body's defense system target cancer cells more effectively.See study design
What are the potential side effects?
Cemiplimab may cause immune-related side effects such as inflammation in organs like lungs (pneumonitis) or liver (hepatitis), allergic reactions during infusion, fatigue, skin reactions, and possibly worsen pre-existing conditions related to immunity.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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My cancer can be removed with surgery, and I will be evaluated before the surgery.
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My kidney function, measured by creatinine, is within the normal range.
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I agree not to donate blood or reproductive cells during and for 6 months after treatment.
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I have been diagnosed with high-risk skin cancer.
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I am fully active and can carry on all pre-disease activities without restriction.
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Side effects from my last cancer treatment are mild or gone.
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I am only using low molecular weight heparin for blood thinning.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~from baseline up to 10 years post-treatment
This trial's timeline: 3 weeks for screening, Varies for treatment, and from baseline up to 10 years post-treatment for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Pathologic response rate
Secondary outcome measures
Overall survival (OS)
Recurrence-free survival (RFS)
Time to local recurrence
+1 more
Other outcome measures
Body Weight Changes

Trial Design

1Treatment groups
Experimental Treatment
Group I: Treatment (cemiplimab)Experimental Treatment3 Interventions
NEOADJUVANT PHASE: Prior to standard of care surgery, patients receive cemiplimab IV over 30 minutes on day 1. Treatment repeats every 21 days for up to 3 cycles in the absence of disease progression or unacceptable toxicity. ADJUVANT PHASE: Within 2-6 weeks after standard of care radiation therapy (or surgery if no radiation therapy), patients receive cemiplimab IV over 30 minutes on day 1. Treatment repeats every 21 days for up to 18 cycles in the absence of disease progression or unacceptable toxicity.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Therapeutic Conventional Surgery
2005
Completed Phase 3
~9850
Radiation Therapy
2017
Completed Phase 3
~7250
Cemiplimab
2015
Completed Phase 3
~1340

Find a Location

Who is running the clinical trial?

National Cancer Institute (NCI)NIH
13,660 Previous Clinical Trials
40,924,314 Total Patients Enrolled
Emory UniversityLead Sponsor
1,638 Previous Clinical Trials
2,560,512 Total Patients Enrolled
Ragini R KudchadkarPrincipal InvestigatorEmory University

Media Library

Cemiplimab (Monoclonal Antibodies) Clinical Trial Eligibility Overview. Trial Name: NCT04428671 — Phase 1
Squamous Cell Carcinoma Research Study Groups: Treatment (cemiplimab)
Squamous Cell Carcinoma Clinical Trial 2023: Cemiplimab Highlights & Side Effects. Trial Name: NCT04428671 — Phase 1
Cemiplimab (Monoclonal Antibodies) 2023 Treatment Timeline for Medical Study. Trial Name: NCT04428671 — Phase 1

Frequently Asked Questions

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

In what medical circumstances is Radiation Therapy typically employed?

"Radiation Therapy is an effective strategy for the treatment of alk gene mutation and other illnesses such as advanced directives, malignant tumours, and metastatic cutaneous squamous cell carcinoma."

Answered by AI

What is the current enrollment size for this clinical trial?

"Correct. Details available on clinicaltrials.gov confirm that enrollment is still in progress for this medical trial, with its initial posting dated May 15th 2020 and the most recent edit taking place June 28th 2022. The study seeks 20 participants from a single research site."

Answered by AI

What other experiments have been conducted involving Radiation Therapy?

"Currently, 56 clinical studies are delving into the efficacy of Radiation Therapy. Out of those active trials, 4 have entered Phase 3 testing. The bulk of these research projects for this type of treatment take place in Barcelona and California but there is a total 1741 locations running investigations with respect to radiation therapy."

Answered by AI

Are there still openings for individuals to participate in this clinical trial?

"Confirmed. Data on clinicaltrials.gov reveals that this experiment, which was initially made available to the public in mid-May 2020, is currently welcoming participants into its ranks. The post has been overhauled since then with a recent update from late June 2022."

Answered by AI

Has the FDA sanctioned Radiation Therapy as a legitimate medical treatment?

"As this is an early stage 1 trial, there is little information regarding safety and efficacy. Consequently, our expert team at Power assigned a rating of 1 to Radiation Therapy for its level of risk."

Answered by AI
Recent research and studies
clinicaltrials.govStudy
Cemiplimab Before and After Surgery for the Treatment of High Risk Cutaneous Squamous Cell Cancer
Michael Lowe 2020. "Cemiplimab Before and After Surgery for the Treatment of High Risk Cutaneous Squamous Cell Cancer". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT04428671.
~12 spots leftby Oct 2030
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