NRG, NRG-HN014, Ph III, Randomized, Immunotherapy vs SOC, CSCC

What is the Purpose of this Study?

Primary Objective: To determine if neoadjuvant immunotherapy combined with response-adapted oncologic surgery improves site-reported event-free survival (EFS) compared to standard-of-care surgery in resectable stage III/IV CSCC. Secondary Objectives: To compare disease-free survival (DFS) between arms. To compare overall survival (OS) between arms. To compare adverse events (CTCAE v5.0) between arms. To assess pathologic complete response in Arm 2.


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
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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