As the second most common skin malignancy in the United States (behind basal cell carcinoma), it is essential for clinicians to remain informed about cutaneous squamous cell carcinoma (cSCC) clinical trials. The resulting data may inform therapeutic strategies, affect clinical guidelines, and expand treatment options, which can ultimately improve patient quality of life.

Today's trials rundown focuses on five active, Phase 3 clinical trials focusing on cSCC. Two of the five trials are currently recruiting, and the overall range of completion date estimates spans 2026 through 2031. The trials are arranged by start date.

Quick View Table of cSCC Clinical Trials
Study TitleRecruiting?Estimated EnrollmentStart DateEstimated Completion
Testing the Addition of an Immunotherapy Drug, Cemiplimab (REGN2810), Plus Surgery to the Usual Surgery Alone for Treating Advanced Skin CancerYes420February 2025August 2031
Study of Intralesional Cemiplimab in Adult Patients With Early Stage Cutaneous Squamous Cell CarcinomaYes369January 2025May 2030
A Study of (Neo)Adjuvant Intismeran Autogene (V940) and Pembrolizumab in Cutaneous Squamous Cell Carcinoma (V940-007) (INTerpath-007)No46April 2024March 2026
Study of Adjuvant Cemiplimab Versus Placebo After Surgery and Radiation Therapy in Patients With High Risk Cutaneous Squamous Cell CarcinomaNo415June 2019March 2028
Pembrolizumab (MK-3475) Versus Placebo Following Surgery and Radiation in Participants With Locally Advanced Cutaneous Squamous Cell Carcinoma (MK-3475-630/​KEYNOTE-630)No459April 2019January 2026
Phase 3 Clinical Trials Focusing Primarily on cSCC

Testing the Addition of an Immunotherapy Drug, Cemiplimab (REGN2810), Plus Surgery to the Usual Surgery Alone for Treating Advanced Skin Cancer

  • Sponsor: National Cancer Institute (NCI)
  • Goal: To determine if neoadjuvant immunotherapy combined with response-adapted oncologic surgery improves site-reported event-free survival compared to standard-of-care surgery in resectable stage III/IV cutaneous squamous cell carcinoma.
  • Interventions: Biospecimen collection, cemiplimab, computed tomography, image guided radiation therapy, intensity-modulated radiation therapy, magnetic resonance imaging, positron emission tomography, surgical procedures
  • Primary Outcome Measure: Event-free survival
  • Time Frame: Up to six years
  • Study Details
  • Source

Study of Intralesional Cemiplimab in Adult Patients With Early Stage Cutaneous Squamous Cell Carcinoma

  • Sponsor: Regeneron Pharmaceuticals
  • Goal: This study will test a study drug called cemiplimab to see if it can help treat early-stage cutaneous squamous cell carcinoma, a type of skin cancer.
  • Interventions: Cemiplimab
  • Primary Outcome Measures: Event-free survival (EFS) as assessed by the investigator; EFS as assessed by the investigator.
  • Time Frames: Up to one year; Up to three years.
  • Study Details
  • Source

A Study of (Neo)Adjuvant Intismeran Autogene (V940) and Pembrolizumab in Cutaneous Squamous Cell Carcinoma (V940-007) (INTerpath-007)

  • Sponsor: Merck Sharp & Dohme 
  • Goal: This is a two-part (Phase 2/Phase 3) study of intismeran autogene, an individualized neoantigen therapy, plus pembrolizumab in participants with locally resectable advanced cutaneous squamous cell carcinoma.
  • Interventions: Pembrolizumab, intismeran autogene, surgery
  • Primary Outcome Measure: Event free survival
  • Time Frame: Up to ~22 months
  • Study Details
  • Source

Study of Adjuvant Cemiplimab Versus Placebo After Surgery and Radiation Therapy in Patients With High Risk Cutaneous Squamous Cell Carcinoma

  • Sponsor: Regeneron Pharmaceuticals
  • Goal: The primary objective of the study is to compare disease-free survival (DFS) of patients with high-risk cutaneous squamous cell carcinoma treated with adjuvant cemiplimab, versus those treated with placebo, after surgery and radiation therapy.
  • Interventions: Cemiplimab, placebo
  • Primary Outcome Measure: DFS defined as time from randomization to the first documented disease recurrence (local, regional and/or distant); or death due to any cause
  • Time Frame: Up to 54 months
  • Study Details
  • Source

Pembrolizumab (MK-3475) Versus Placebo Following Surgery and Radiation in Participants With Locally Advanced Cutaneous Squamous Cell Carcinoma (MK-3475-630/​KEYNOTE-630)

  • Sponsor: Merck Sharp & Dohme
  • Goal: This is a randomized, double-blind, study that compares pembrolizumab (MK-3475) with placebo given as adjuvant therapy in participants with high-risk locally advanced cutaneous squamous cell carcinoma that have undergone surgery with curative intent in combination with radiotherapy.
  • Interventions: Pembrolizumab, placebo
  • Primary Outcome Measure: Recurrence-Free Survival as assessed by the investigator and confirmed by biopsy
  • Time Frame: Up to approximately 62 months
  • Study Details
  • Source
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