Randomized Phase III Trial of Perioperative Immunotherapy With Response-Adapted Treatment Versus Standard-of-Care Treatment for Resectable Stage III/IV Cutaneous Squamous Cell Carcinoma
Volunteers
Health Professionals
What is the purpose of this trial?
This phase III trial compares the effect of adding cemiplimab to standard therapy (surgery with or without radiation) versus standard therapy alone in treating patients with stage III/IV squamous cell skin cancer that is able to be removed by surgery (resectable) and that may have come back after a period of improvement (recurrent). The usual treatment for patients with resectable squamous cell skin cancer is the removal of the cancerous tissue (surgery) with or without radiation, which uses high energy x-rays, particles, or radioactive seeds to kill cancer cells and shrink tumors. Immunotherapy with monoclonal antibodies, such as cemiplimab, may help the body's immune system attack the cancer, and may interfere with the ability of tumor cells to grow and spread. Cemiplimab has been approved for the treatment of skin cancer that has spread or that cannot be removed by surgery, but it has not been approved for the treatment of skin cancer than can be removed by surgery. Adding cemiplimab to the usual treatment of surgery with or without radiation may be more effective in treating patients with stage III/IV resectable squamous cell skin cancer than the usual treatment alone.
Help Us Discover!
You can help our team find trials you might be eligible for by creating a volunteer profile in MyChart. To get started, create a volunteer profile, or contact helpusdiscover@yale.edu, or call 877.978.8343 for more information.
Principal Investigator
Sub-Investigators
- Aarti Bhatia, MD, MPH
- Allison Campbell, MD, PhD
- Andrea Brennan
- Armand Russo, MD
- Avanti Verma, MD
- Barbara Burtness, MD
- Benjamin Newton, MD
- Benjamin L. Judson, MD, MBA
- Bruce A. McGibbon, MD
- Clarice Grens
- D. Barry Boyd, MD, MS
- Daniel Hicks, MD
- David Schoenfeld, MD, PhD
- David A. Braun, MD, PhD
- Elan Gorshein, DO, JD, MPH
- Emily Kopas, APRN, OCN
- Harold Tara Jr, MD
- Harriet Kluger, MD
- Henry S. Park, MD, MPH
- Jadwiga Kretowicz
- James Clune, MD
- James Laird, MD
- Jason Haldas, MD
- Jeffrey Ishizuka, MD, DPhil
- Johanna LaSala, MD
- Julie Kang, MD, PhD
- Justin Persico, MD
- Kelly Olino, MD, FACS
- Kimberly L. Johung, MD, PhD
- Larisa Fleysher
- Lynsey Teulings
- M. Sung Lee, MD
- Mario Sznol, MD
- Matthew Austin, MD
- Melissa Rasar Young, MD, PhD
- Michael Chiorazzi, PhD, MD
- Michael Grant, MD
- Michael Hurwitz, MD, PhD
- Robert Legare, MD
- Sajid A Khan, MD, FACS, FSSO
- Sanjay Aneja, MD
- Sara Isabel Pai, MD, PhD
- Sarah Carlson
- Saral Mehra, MD, MBA, FACS
- Stephen Lattanzi, MD
- Su Hsien Lim, MD
- Suresh Mohan, MD
- Thomas Hayman, MD, PhD
- Thuy Tran, MD, PhD
- Timothy Robinson, MD, PhD
- Wajih Kidwai, MD, FACP
- Yi An, MD
- Yifei Zhang, MD
- Zafar Sayed, MD
- Last Updated12/07/2025
- Study HIC#2000039679