Pre-Operative Cemiplimab Administered Intralesionally for Patients With Recurrent Cutaneous Squamous Cell Carcinoma

  • STATUS
    Recruiting
  • End date
    Feb 23, 2022
  • participants needed
    36
  • sponsor
    Regeneron Pharmaceuticals
Updated on 14 February 2021
measurable disease
cemiplimab
intralesional injection

Summary

The primary objective is to characterize the safety and tolerability of cemiplimab injected intralesionally in patients with recurrent CSCC.

The secondary objectives of this study are:

  • To describe the objective response rate (ORR) in CSCC index lesions following intralesional injections of cemiplimab in patients with recurrent CSCC, according to modified World Health Organization (WHO) criteria
  • To describe the pathologic complete response (CR) rate in CSCC index lesions following intralesional injections of cemiplimab in patients with recurrent CSCC
  • To describe the major pathologic response rate in CSCC index lesions following intralesional injections of cemiplimab in patients with recurrent CSCC
  • To evaluate systemic exposure of cemiplimab following intralesional injections of cemiplimab in patients with recurrent CSCC
  • To assess the immunogenicity of cemiplimab in patients with recurrent CSCC
  • To establish a recommended dose of intralesional cemiplimab for further study in patients with recurrent CSCC

Details
Condition Cutaneous Squamous Cell Carcinoma, Skin Squamous Cell Carcinoma, squamous cell skin cancer
Treatment Cemiplimab
Clinical Study IdentifierNCT03889912
SponsorRegeneron Pharmaceuticals
Last Modified on14 February 2021

Similar trials to consider

Loading...

Browse trials for

Not finding what you're looking for?

Every year hundreds of thousands of volunteers step forward to participate in research. Sign up as a volunteer and receive email notifications when clinical trials are posted in the medical category of interest to you.

Sign up as volunteer

user name

Added by • 

 • 

Private

Reply by • Private
Loading...

Lorem ipsum dolor sit amet consectetur, adipisicing elit. Ipsa vel nobis alias. Quae eveniet velit voluptate quo doloribus maxime et dicta in sequi, corporis quod. Ea, dolor eius? Dolore, vel!

  The passcode will expire in None.
Loading...

No annotations made yet

Add a private note
  • abc Select a piece of text from the left.
  • Add notes visible only to you.
  • Send it to people through a passcode protected link.
Add a private note