Neoadjuvant Immunotherapy With Response-Adapted Treatment in Resectable Stage III/IV Cutaneous Squamous Cell Carcinoma

What is the Purpose of this Study?

This study focuses on people who have advanced squamous cell skin cancer that can be removed with surgery. The purpose of the study is to determine whether giving an immunotherapy drug called cemiplimab before and (in some cases) after surgery extends the length of time without the patient’s cancer returning compared to the usual approach. The usual approach is treatment with surgery. Patients in either treatment group may receive radiation after surgery (depending on the tumor tissue results from the surgery). The addition of cemiplimab (REGN2810) to the usual treatment could shrink the patient’s cancer, prevent it from returning, and/or reduce the need for radiation after surgery, but may also cause side effects. Participants will be randomly assigned to 1 of 2 groups. Group 1 will receive the usual surgery; after surgery, they may receive the usual type of radiation, depending on the results from the tumor tissue removed during surgery. Group 2 will receive cemiplimab before undergoing surgery for cancer. After surgery, they may also get the usual type of radiation, depending on the results from the tumor tissue removed during surgery. They may also receive cemiplimab (REGN2810) after surgery and radiation, depending on the tumor tissue results. Cemiplimab is approved by the U.S. Food and Drug Administration (FDA) for use in skin cancer that has spread or that cannot be treated with surgery or radiation, but its use in in skin cancer that can be removed with surgery is considered experimental.


Eligibility

  • * Pathologically (histologically or cytologically) proven diagnosis of invasive cutaneous squamous cell carcinoma (CSCC) or regional lymph node or in-transit metastasis of CSCC
  • * For patients with regional metastasis without a primary tumor at screening: a clinical history of CSCC that drains to the involved regional lymph nodes or in-transit metastases in question is required
Show more

Where can I participate?

  • CS Cancer at Beverly Hills : Maria Tarallo
  • CS Cancer at Cedars-Sinai Medical Center : Maria Tarallo
  • CS Cancer at The Angeles Clinic and Research Institute : Maria Tarallo


More about this Clinical Trial

What is the full name of this clinical trial?

NRG-HN014: Randomized Phase III Trial of Neoadjuvant Immunotherapy with Response-adapted Treatment versus Standard of Care Treatment for Resectable Stage III/IV Cutaneous Squamous Cell Carcinoma

Study Details
Disease Type/Condition

Unknown Sites

Principal Investigator

Zumsteg, Zachary

Co-Investigators

Allen Ho, Cathie T Chung, Evan Walgama, Inderjit Mehmi, Jeremy Lorber, Jon Mallen-St. Clair, Justin Moyers, Kevin Scher, Kristopher Wentzel, Mark Faries, Navid Hafez, Omid Hamid, Trevan Fischer, Vi K. Chiu

Age Group

Adult

Phase

III

IRB Number

STUDY00004078

ClinicalTrials.gov ID

NCT06568172

Key Eligibility
ClinicalTrials.gov

How do I learn more about this study?
Name

Maria Tarallo

Email
Maria.Tarallo@cshs.org
Study Detail
Disease Type/Condition

Unknown Sites

Principal Investigator

Zumsteg, Zachary

Age Group

Adult

Phase

III

IRB Number

NRG-HN014

ClinicalTrials.gov ID

NCT06568172

Key Eligibility
ClinicalTrials.gov

Contact
Name

Maria Tarallo

Email
Maria.Tarallo@cshs.org