Basket study of MK-4280A in select solid tumors (Cutaneous Squamous Cell Carcinoma)

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:
  • Are diagnosed with cSCC
  • Have Stage II to Stage IV disease that is resectable (can be treated with surgery)
  • Have not been treated with chemotherapy, EGFR inhibitors, or PD-1/PD-L1 inhibitors
For more information about this study, contact the study team at danielle.myers@duke.edu.

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?

Description

If you agree to take part in this study, you will get a random assignment (like a coin flip) to 1 of 2 groups:
  • Group 1: If you are in this group, you will get the study drug before and after your surgery.
  • Group 2: If you are in this group, you will get pembrolizumab (the standard, approved drug) before and after your surgery.
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
ClinicalTrials.gov