Purpose of this Study
We are doing this study to find out if an experimental drug called MK-4280A (the study drug) is a safe and effective option for people who are diagnosed with different types of solid tumors. We are enrolling Arm A of this study, which is open to people diagnosed with cutaneous squamous cell carcinoma (cSCC).
Who Can Participate?
Eligibility
Adults ages 18+ who:<ul>
<li>Are diagnosed with cSCC</li>
<li>Have Stage II to Stage IV disease that is resectable (can be treated with surgery)</li>
<li>Have not been treated with chemotherapy, EGFR inhibitors, or PD-1/PD-L1 inhibitors</li></ul>
For more information about this study, contact the study team at <a href= "mailto: danielle.myers@duke.edu">danielle.myers@duke.edu.</a>
<li>Are diagnosed with cSCC</li>
<li>Have Stage II to Stage IV disease that is resectable (can be treated with surgery)</li>
<li>Have not been treated with chemotherapy, EGFR inhibitors, or PD-1/PD-L1 inhibitors</li></ul>
For more information about this study, contact the study team at <a href= "mailto: danielle.myers@duke.edu">danielle.myers@duke.edu.</a>
Age Range
18-110
Sex/Genders
Male (cisgender)
Female (cisgender)
Non-binary or gender fluid
Transgender male
Transgender female
Looking for Healthy Participants
No
What is Involved?
If you agree to take part in this study, you will get a random assignment (like a coin flip) to 1 of 2 groups:<ul>
<li><strong>Group 1:</strong> If you are in this group, you will get the study drug before and after your surgery.</li>
<li><strong>Group 2:</strong> If you are in this group, you will get pembrolizumab (the standard, approved drug) before and after your surgery.</li></ul>
You will take your assigned drug for about 9 weeks before your surgery. You will visit our clinic about 4 times and get the trial drug up to 3 times. Both the study drug and pembrolizumab are given every 3 weeks by a needle into a vein (IV).
You will then have surgery for your cSCC. The trial doctor will talk with you about when this surgery will be scheduled. This surgery is considered the standard of care, which means you would have it even if you were not taking part in this trial. If you are not able to have surgery or if you decide not to have surgery, you may be asked to have a biopsy instead. The study doctor will discuss this with you.
You will start getting the study drug or pemborlizumab about 4 to 12 weeks after your surgery or after your last dose of radiation.
<li><strong>Group 1:</strong> If you are in this group, you will get the study drug before and after your surgery.</li>
<li><strong>Group 2:</strong> If you are in this group, you will get pembrolizumab (the standard, approved drug) before and after your surgery.</li></ul>
You will take your assigned drug for about 9 weeks before your surgery. You will visit our clinic about 4 times and get the trial drug up to 3 times. Both the study drug and pembrolizumab are given every 3 weeks by a needle into a vein (IV).
You will then have surgery for your cSCC. The trial doctor will talk with you about when this surgery will be scheduled. This surgery is considered the standard of care, which means you would have it even if you were not taking part in this trial. If you are not able to have surgery or if you decide not to have surgery, you may be asked to have a biopsy instead. The study doctor will discuss this with you.
You will start getting the study drug or pemborlizumab about 4 to 12 weeks after your surgery or after your last dose of radiation.
Locations
Duke University Hospital
Duke Raleigh Hospital
Visit Timing
Weekdays
Compensation
No
Spanish Materials Available
No
Study Details
Full Title
A Multicenter, Randomized Double-Blind, Phase 2, Basket Study of MK-4280A, a Coformulation of Favezelimab (MK-4280) with Pemborlizumab (MK-3475) in Selected Solid Tumors
Principal Investigator
Jameel
Muzaffar
Protocol Number
PRO00114028
NCT ID
NCT06036836
Phase
II
Enrollment Status
Open to Enrollment