Today, we will be looking into the latest research and clinical trials focused on squamous cell carcinoma.

The following list has been carefully curated by evaluating the ongoing Phase 3 trials for squamous cell carcinoma, specifically targeting adults in the United States. Please note that the dates provided are approximate and subject to change. This compilation primarily features studies that have released updates within the past 12 months.

This series aims to offer a glimpse into upcoming innovations in the field and how the outcomes of these studies could potentially influence clinical guidelines related to the topic.

Lets go ahead and explore the list of Squamous Cell Carcinoma Clinical Trials!

Quick View Table of Squamous Cell Carcinoma Clinical Trials
Study TitlePhaseEnrollmentStart DateLast Update Posted
A Study of Dostarlimab vs Placebo After Chemoradiation in Adult Participants With Locally Advanced Unresected Head and Neck Squamous Cell Carcinoma (JADE)Phase 386403/21/202407/29/2024
RT With or Without Cetuximab in Treating Patients Who Have Undergone Surgery for Locally Advanced Head and Neck CancerPhase 370203/31/201005/28/2024
Study of Intralesional Cemiplimab in Adult Patients With Early Stage Cutaneous Squamous Cell CarcinomaPhase 336901/02/202502/25/2025
Testing the Addition of an Immunotherapy Drug, Cemiplimab (REGN2810), Plus Surgery to the Usual Surgery Alone for Treating Advanced Skin CancerPhase 342002/18/202505/08/2025
A Study of (Neo)Adjuvant V940 and Pembrolizumab in Cutaneous Squamous Cell Carcinoma (V940-007)Phase 2
Phase 3		101204/18/202401/29/2025
5-Fluorouracil and Calcipotriene for Treatment of Low Grade Skin CancerPhase 2
Phase 3		20010/15/202212/24/2024
Nivolumab After Combined Modality Therapy in Treating Patients With High Risk Stage II-IIIB Anal CancerPhase 334407/05/201804/10/2025
Phase 3 Clinical Trials:

A Study of Dostarlimab vs Placebo After Chemoradiation in Adult Participants With Locally Advanced Unresected Head and Neck Squamous Cell Carcinoma (JADE)

Source

  • Sponser: GlaxoSmithKline
  • The goal of this study is to assess the safety and effectiveness of Dostarlimab compared to Placebo in adult participants with HNSCC (Head and Neck Squamous Cell Carcinoma)
  • Interventions:
    • Drug: Dostarlimab
    • Drug: Placebo
  • Primary Outcome Measures:
    • Event-free Survival (EFS) Assessed by Blinded Independent Central Review (BICR)
      • Event Free Survival (EFS) is defined as the time from the date of randomization to the date of an event, where an event is defined as locoregional progression or recurrence, or distant metastasis per Response Evaluation Criteria in Solid Tumors (RECIST) 1.1 as per BICR; Salvage surgery at the primary tumor site; Neck dissection or surgery performed >20 weeks after completion of or Death from any cause.
    • Time Frame – Up to approximately 5 years

RT With or Without Cetuximab in Treating Patients Who Have Undergone Surgery for Locally Advanced Head and Neck Cancer

Source

  • Sponser: Radiation Therapy Oncology Group
  • This randomized phase III trial is studying radiation therapy to see how well it works compared with radiation therapy given together with cetuximab in treating patients who have undergone surgery for locally advanced head and neck cancer.
  • Interventions:
    • Biological: cetuximab
    • Radiation: intensity-modulated radiation therapy
  • Primary Outcome Measures:
    • Percentage of Participants Alive (Overall Survival)
      • Overall survival time is defined as time from registration/randomization to the date of death from any cause or last known follow-up (censored). Overall survival rates are estimated by the Kaplan-Meier method. Analysis occurred after all participants had potentially been on study for at least 5 years. The distributions of survival times are compared, which is reported in the statistical analysis results. Five-year rates are provided.
    • Time Frame – Maximum follow-up at time of analysis was 12.1 years.

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

Source

  • Sponsor: Regeneron Pharmaceuticals
  • The main purpose of this study is to compare how well cemiplimab works compared to surgery, when injected into the lesion.
  • Interventions:
    • Drug: Cemiplimab
    • Procedure: Standard of care
  • Primary Outcome Measures:
    • Event-Free Survival (EFS) as assessed by the investigator
    • Time Frame – up to 1 and 3 years

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

Source

  • Sponsor: National Cancer Institute (NCI)
  • 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 cutaneous squamous cell carcinoma (CSCC).
  • Interventions:
    • Procedure: Biospecimen Collection
    • Biological: Cemiplimab
    • Procedure: Computed Tomography
    • Radiation: Image Guided Radiation Therapy
    • Radiation: Intensity-Modulated Radiation Therapy
    • Procedure: Magnetic Resonance Imaging
    • Procedure: Positron Emission Tomography
    • Other: Questionnaire Administration
    • Procedure: Surgical Procedure
    • Procedure: Surgical Procedure
  • Primary Outcome Measures:
    • Event-free survival (EFS)
    • Time Frame – Up to 6 years

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

Source

  • Sponsor: Merck Sharp & Dohme LLC
  • The primary hypothesis is that V940 plus pembrolizumab with SOC is superior to SOC only with respect to event free survival (EFS) as assessed by the investigator. Phase 3 expansion will be determined by prespecified Go-No-Go decision in which 412 additional participants will be randomized to V940 plus pembrolizumab with SOC and SOC only, without changing the inclusion/exclusion criteria for the additional enrollment or study endpoints.
  • Interventions:
    • Biological: Pembrolizumab
    • Biological: V940
    • Procedure: Surgery
  • Primary Outcome Measures:
    • Event Free Survival (EFS)
      • EFS is defined as the time from randomization to any of the following events as assessed by the investigator: progression of disease that precludes surgery, or inability to undergo R0 or R1 surgical resection; disease recurrence (local, regional, or distant); new primary high-risk cSCC; death due to any cause. EFS will be presented.
    • Time Frame – Up to ~59 months

5-Fluorouracil and Calcipotriene for Treatment of Low Grade Skin Cancer

Source

  • Sponsor: Boston University
  • The investigators will compare the application of two different creams for the treatment of low-risk skin cancers-superficial basal cell carcinoma (sBCC) and squamous cell carcinoma in situ (SCCis).
  • Interventions:
    • Drug: Combination cream of 5-fluorouracil and calcipotriene
    • Drug: 5-fluorouracil cream
  • Primary Outcome Measures:
    • Clearance rate of cancer lesions at 3 months
      • Clearance rate is defined as the percentage of lesions that are free of cancer based on clinical assessments which will be performed by the patient's dermatologist and via photos from a standardized full frontal angle.
    • Time Frame – 3 months
    • Clearance rate of cancer lesions at 3 years
      • Clearance rate is defined as the percentage of lesions that are free of cancer based on clinical assessments which will be performed by the patient's dermatologist and via photos from a standardized full frontal angle.
    • Time Frame – 3 years

Nivolumab After Combined Modality Therapy in Treating Patients With High Risk Stage II-IIIB Anal Cancer

Source

  • Sponsor: National Cancer Institute (NCI)
  • This phase III trial investigates how well nivolumab after combined modality therapy works in treating patients with high risk stage II-IIIB anal cancer.
  • Interventions:
    • Procedure: Biopsy Procedure
    • Procedure: Biospecimen Collection
    • Procedure: Colonoscopy
    • Procedure: Computed Tomography
    • Procedure: Digital Rectal Examination
    • Procedure: High Resolution Anoscopy
    • Procedure: Magnetic Resonance Imaging
    • Biological: Nivolumab
    • Other: Patient Observation
    • Procedure: Proctoscopy
    • Procedure: Sigmoidoscopy
    • Procedure: X-Ray Imaging
  • Primary Outcome Measures:
    • Disease free survival
      • Will be defined as the occurrence of progression of local disease, distant metastases, second primary or death from the date of randomization.
    • Time Frame – Up to 5 years
Potential Guidelines That May Be Affected Include:

There you have it – a list of phase 3 Clinical Trials for Squamous Cell Carcinoma as of May 2025. Stay tuned, for our next Guidelines+ Trials Rundown. Sign up for alerts and stay informed on the latest published guidelines and articles.

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