Cemiplimab for Carcinoma, Squamous Cell

Phase-Based Progress Estimates
1
Effectiveness
1
Safety
Icahn School of Medicine at Mount Sinai, New York, NY
Carcinoma, Squamous Cell+4 More
Cemiplimab - Drug
Eligibility
18+
All Sexes
What conditions do you have?
Select

Study Summary

The purpose of this research study is to determine the safety and tolerability of two dosing schedules of cemiplimab given in combination with cisplatin and docetaxel induction chemotherapy (TPI) in patients with locally advanced squamous cell carcinoma of the head and neck (LA SCCHN). Cemiplimab is FDA approved for treatment of basal cell and squamous cell carcinoma of the skin as well as non-small cell lung cancer but not for squamous cell carcinoma of head and neck.

Eligible Conditions

  • Carcinoma, Squamous Cell
  • Squamous cell carcinoma

Treatment Effectiveness

Effectiveness Progress

1 of 3

Study Objectives

1 Primary · 20 Secondary · Reporting Duration: At the end of Cycle 3 (each cycle is 21 days)

Week 3
Dose-limiting toxicity (DLT)
Day 21
Adverse events during induction therapy
Alkaline phosphatase (ALP)
Bicarbonate (CO2)
Blood Pressure
Blood Urea Nitrogen (BUN)
Calcium
Complete White Count (CBC)
Direct bilirubin
Glucose
Heart Rate
Lactate Dehydrogenase (LDH)
Magnesium
Phosphate
Potassium
SGOT (AST)
SGPT (ALT)
Sodium
Temperature
Total bilirubin
Uric Acid

Trial Safety

Safety Progress

1 of 3

Trial Design

2 Treatment Groups

Cohort A
1 of 2
Cohort B
1 of 2
Experimental Treatment

24 Total Participants · 2 Treatment Groups

Primary Treatment: Cemiplimab · No Placebo Group · Phase 1

Cohort AExperimental Group · 3 Interventions: Cemiplimab, Cisplatin, Docetaxel · Intervention Types: Drug, Drug, Drug
Cohort BExperimental Group · 3 Interventions: Cemiplimab, Cisplatin, Docetaxel · Intervention Types: Drug, Drug, Drug
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Cemiplimab
2015
Completed Phase 1
~400
Cisplatin
2013
Completed Phase 3
~3340
Docetaxel
1995
Completed Phase 4
~8840

Trial Logistics

Trial Timeline

Approximate Timeline
Screening: ~3 weeks
Treatment: Varies
Reporting: at the end of cycle 3 (each cycle is 21 days)
Closest Location: Icahn School of Medicine at Mount Sinai · New York, NY
Photo of icahn school of medicine at mount sinai 1Photo of icahn school of medicine at mount sinai 2Photo of icahn school of medicine at mount sinai 3
1997First Recorded Clinical Trial
14 TrialsResearching Carcinoma, Squamous Cell
529 CompletedClinical Trials

Who is running the clinical trial?

Krzysztof MisiukiewiczLead Sponsor
1 Previous Clinical Trials
40 Total Patients Enrolled
1 Trials studying Carcinoma, Squamous Cell
40 Patients Enrolled for Carcinoma, Squamous Cell
Regeneron PharmaceuticalsIndustry Sponsor
534 Previous Clinical Trials
195,454 Total Patients Enrolled
17 Trials studying Carcinoma, Squamous Cell
2,934 Patients Enrolled for Carcinoma, Squamous Cell
Krzysztof Misiukiewicz, MDPrincipal InvestigatorIcahn School of Medicine at Mount Sinai
1 Previous Clinical Trials
10 Total Patients Enrolled

Eligibility Criteria

Age 18+ · All Participants · 10 Total Inclusion Criteria

Mark “yes” if the following statements are true for you:
A biopsy of the primary site is required.
You have a life expectancy of more than 12 weeks.
You have stage III or IV, previously untreated, locally advanced HNSCC.

About The Reviewer

Michael Gill preview

Michael Gill - B. Sc.

First Published: October 9th, 2021

Last Reviewed: August 12th, 2022

Michael Gill holds a Bachelors of Science in Integrated Science and Mathematics from McMaster University. During his degree he devoted considerable time modeling the pharmacodynamics of promising drug candidates. Since then, he has leveraged this knowledge of the investigational new drug ecosystem to help his father navigate clinical trials for multiple myeloma, an experience which prompted him to co-found Power Life Sciences: a company that helps patients access randomized controlled trials.