Carcinoma, Squamous Cell
Recent clinical, regulatory, research and industry developments relating to this disease.
The Use of Immune Regulation in Treating Head and Neck Squamous Cell Carcinoma (HNSCC).
Biological biomarkers of oral cancer.
Oral squamous cell carcinomas: state of the field and emerging directions.
What's happening now
An analyst briefing on current research, clinical, regulatory and industry activity surrounding this disease.
- 4 clinical trials expected to report results, the earliest in Q3 2026.
- Q3 2026An Open Label Phase I PET Imaging Study to Investigate the Bio-distribution and Tumor Uptake of [89Zr]Zr-BI 765063 and [89Zr]Zr-BI 770371 in Patients With Head and Neck Squamous Cell Carcinoma, Non-small Cell Lung Cancer or Melanoma Who Are Treated With Ezabenlimab
- Q3 2027Phase I, Dual Arm, Open-Label, Trial of Intralesional 5-Fluorouracil (5FU) and Intralesional 5FU Combined With Topical Calcipotriene in Patients With Squamous Cell Carcinoma (SCC) of the Lower Extremities
- Q2 2028A Phase 3 Study of NBTXR3 Activated by Investigator's Choice of Radiotherapy Alone or Radiotherapy in Combination With Cetuximab for Platinum-based Chemotherapy-Ineligible Elderly Patients With Locally Advanced Head & Neck Squamous Cell Carcinoma
- Q1 2029A Phase II, Multi-center, Single Arm Trial of Lenvatinib Plus Pembrolizumab in Patients With Unresectable Locally Advanced and/or Metastatic Anorectal Squamous Cell Carcinoma (ASCC) After Progression on First Line Chemotherapy.
Clinical MilestonesView all 9Hide
- 2026-03-10A Phase 3, Randomized, Double-blind, Placebo-controlled Study to Evaluate Pembrolizumab Versus Placebo as Adjuvant Therapy Following Surgery and Radiation in Participants With High-risk Locally Advanced Cutaneous Squamous Cell Carcinoma (LA cSCC) (KEYNOTE-630)Results posted
- 2026-02-25A Phase 3 Study of Pembrolizumab in Combination With Carboplatin/Taxane (Paclitaxel or Nab-paclitaxel) Followed by Pembrolizumab With or Without Maintenance Olaparib in the First-line Treatment of Metastatic Squamous Non-small Cell Lung Cancer (NSCLC)Results posted
- 2026-02-23Multimodality Therapy With Induction Carboplatin/Nab-Paclitaxel/Durvalumab Followed by Surgical Resection and Risk-adapted Adjuvant Therapy for the Treatment of Locally-Advanced and Surgically Resectable Squamous Cell Carcinoma of the Head and NeckResults posted
- 2025-10-14Comparison of Every 3 Week Versus Weekly Cisplatin Concurrent With Radiation in Squamous Cell Carcinoma of the Head and Neck (SCCHN) and Correlation With Oxidative Stress MarkersResults posted
- 2026-07-06A Phase 3 Study of NBTXR3 Activated by Investigator's Choice of Radiotherapy Alone or Radiotherapy in Combination With Cetuximab for Platinum-based Chemotherapy-Ineligible Elderly Patients With Locally Advanced Head & Neck Squamous Cell CarcinomaResults expected Q2 2028
- 2026-06-01Phase I, Dual Arm, Open-Label, Trial of Intralesional 5-Fluorouracil (5FU) and Intralesional 5FU Combined With Topical Calcipotriene in Patients With Squamous Cell Carcinoma (SCC) of the Lower ExtremitiesResults expected Q3 2027
- 2026-05-27An Open Label Phase I PET Imaging Study to Investigate the Bio-distribution and Tumor Uptake of [89Zr]Zr-BI 765063 and [89Zr]Zr-BI 770371 in Patients With Head and Neck Squamous Cell Carcinoma, Non-small Cell Lung Cancer or Melanoma Who Are Treated With EzabenlimabResults expected Q3 2026
- 2026-04-15A Phase II, Multi-center, Single Arm Trial of Lenvatinib Plus Pembrolizumab in Patients With Unresectable Locally Advanced and/or Metastatic Anorectal Squamous Cell Carcinoma (ASCC) After Progression on First Line Chemotherapy.Results expected Q1 2029
- 2026-07-06ClinicalA Phase 3 Study of NBTXR3 Activated by Investigator's Choice of Radiotherapy Alone or Radiotherapy in Combination With Cetuximab for Platinum-based Chemotherapy-Ineligible Elderly Patients With Locally Advanced Head & Neck Squamous Cell CarcinomaResults expected Q2 2028
- 2026-06-01ClinicalPhase I, Dual Arm, Open-Label, Trial of Intralesional 5-Fluorouracil (5FU) and Intralesional 5FU Combined With Topical Calcipotriene in Patients With Squamous Cell Carcinoma (SCC) of the Lower ExtremitiesResults expected Q3 2027
- 2026-05-27ClinicalAn Open Label Phase I PET Imaging Study to Investigate the Bio-distribution and Tumor Uptake of [89Zr]Zr-BI 765063 and [89Zr]Zr-BI 770371 in Patients With Head and Neck Squamous Cell Carcinoma, Non-small Cell Lung Cancer or Melanoma Who Are Treated With EzabenlimabResults expected Q3 2026
- 2026-04-15ClinicalA Phase II, Multi-center, Single Arm Trial of Lenvatinib Plus Pembrolizumab in Patients With Unresectable Locally Advanced and/or Metastatic Anorectal Squamous Cell Carcinoma (ASCC) After Progression on First Line Chemotherapy.Results expected Q1 2029
- 2026-03-10ClinicalA Phase 3, Randomized, Double-blind, Placebo-controlled Study to Evaluate Pembrolizumab Versus Placebo as Adjuvant Therapy Following Surgery and Radiation in Participants With High-risk Locally Advanced Cutaneous Squamous Cell Carcinoma (LA cSCC) (KEYNOTE-630)Results posted
- 2026-03-05ClinicalA Phase 2/3, Adaptive, Randomized, Open-label, Clinical Study to Evaluate Neoadjuvant and Adjuvant Intismeran Autogene (mRNA-4157) in Combination With Pembrolizumab (MK-3475) Versus Standard of Care, and Pembrolizumab Monotherapy in Participants With Resectable Locally Advanced Cutaneous Squamous Cell Carcinoma (LA cSCC) (INTerpath-007)Terminated
- 2026-02-25ClinicalA Phase 3 Study of Pembrolizumab in Combination With Carboplatin/Taxane (Paclitaxel or Nab-paclitaxel) Followed by Pembrolizumab With or Without Maintenance Olaparib in the First-line Treatment of Metastatic Squamous Non-small Cell Lung Cancer (NSCLC)Results posted
- 2026-02-23ClinicalMultimodality Therapy With Induction Carboplatin/Nab-Paclitaxel/Durvalumab Followed by Surgical Resection and Risk-adapted Adjuvant Therapy for the Treatment of Locally-Advanced and Surgically Resectable Squamous Cell Carcinoma of the Head and NeckResults posted
- 2025-10-14ClinicalComparison of Every 3 Week Versus Weekly Cisplatin Concurrent With Radiation in Squamous Cell Carcinoma of the Head and Neck (SCCHN) and Correlation With Oxidative Stress MarkersResults posted
Therapeutic landscape
Therapies with a regulatory footing for this condition, alongside the wider set of agents co-studied with it in the literature.
Approval — Small cell lung cancer (SCLC) Hetronifly in combination with carboplatin and etoposide is… (2025)
Approval — Squamous cell carcinoma of the anal canal (SCAC) Zynyz is indicated in combination with c… (2024)
Approval — Loqtorzi, in combination with cisplatin and gemcitabine, is indicated for the first-line… (2024)
Approval — Non-small cell lung cancer (NSCLC) Tevimbra, in combination with platinum-containing chem… (2023)
Approval — Cutaneous Squamous Cell Carcinoma Libtayo as monotherapy is indicated for the treatment… (2019)
Approval — Urothelial carcinoma Tecentriq as monotherapy is indicated for the treatment of adul… (2017)
Approval — Melanoma Keytruda as monotherapy is indicated for the treatment of adults and adolescents… (2015)
Approval — Breast cancer Docetaxel Kabi in combination with doxorubicin and cyclophosphamide is indi… (2012)
Clinical trials
The current development programme across all trial phases.
Regulatory timeline
Drug regulatory events matched to this condition by indication — EMA.
European Medicines Agency (CC BY 4.0). Events are matched to this condition by drug indication text — approvals/updates for drugs indicated for it, not disease-specific acts.
Research activity
Key research shaping understanding of this disease, combining the latest publications with the most influential evidence.
Major themes8
- Carcinoma, Squamous Cell19
- Head and Neck Neoplasms7
- Lung Neoplasms7
- Mouth Neoplasms6
- Carcinoma, Non-Small-Cell Lung5
- Immune Checkpoint Inhibitors2
- Papillomavirus Infections2
- Penile Neoplasms2
Leading journals6
- The New England journal of medicine6
- Journal for immunotherapy of cancer2
- Journal of clinical oncology : official journal of the American Society of Clinical Oncology2
- Advances in anatomic pathology1
- CA: a cancer journal for clinicians1
- Cancer1
Leading researchers8
- Ajani JA3
- Lu S3
- Paz-Ares L3
- Wang Z3
- Zhang J3
- Brahmer JR2
- Cheng Y2
- Ciuleanu TE2
Affiliations (unnormalised)6
- Hospital Universitario 12 de Octubre3
- Shanghai Lung Cancer Center3
- Emory University School of Medicine2
- H. Lee Moffitt Cancer Center & Research Institute2
- Harbin Medical University Cancer Hospital2
- Icahn School of Medicine at Mount Sinai2
Disease biology
Key proteins & gene products studied in this disease. Number shows shared papers.
Related conditions
Diseases frequently studied alongside this one. Number shows shared papers.
Disease profile
A grounded synthesis of the condition — overview, causes, mechanism, risk factors and current standard of care.
Squamous cell carcinoma is a carcinoma arising from stratified squamous epithelial cells. It can also develop in sites where glandular or columnar epithelium is normally present. The supplied literature focuses on squamous cell carcinomas of the oral cavity, head and neck, and oesophagus.
The literature identifies persistent exposure to tobacco, alcohol, betel quid, and human papillomavirus as etiologic factors for oral squamous cell carcinoma. It also notes that oral potentially malignant disorders can precede oral squamous cell carcinoma. Beyond these associations, the supplied grounding does not support a single universal cause for squamous cell carcinoma as a broad disease category.
The reviewed literature describes squamous cell carcinoma oncogenesis as a multifactorial process involving genetic alteration, epigenetic modification, and dysregulated tumor microenvironment. It also highlights roles for transcriptome changes, signal transduction, and gene expression regulation in the disease biology. Tumor-infiltrating lymphocytes are discussed as part of the immune response with prognostic and predictive relevance in squamous cell carcinoma and other solid tumors.
Persistent exposure to tobacco, alcohol, betel quid, and human papillomavirus increases risk for oral squamous cell carcinoma. Oral potentially malignant disorders are also described as lesions with increased risk of progression to oral squamous cell carcinoma. The supplied grounding does not support additional broad risk factors for all squamous cell carcinomas.
For oesophageal squamous cell carcinoma, the literature describes a multidisciplinary approach with endoscopic procedures for premalignant and early tumors, surgery for localized disease, and neoadjuvant chemotherapy or chemoradiotherapy as standard treatment for locally advanced disease. Several palliative treatment alternatives are also noted. The co-studied drugs and immunotherapy-related agents indicate treatment classes used in this disease context, including platinum-based chemotherapy, fluoropyrimidines, taxanes, and immune checkpoint inhibitors.
AI-generated summary grounded in MeSH and 6 peer-reviewed sources. Informational only — not medical advice. Generated 2026-07-07.
Reference
Authoritative identity, definition & identifiers.
A carcinoma derived from stratified SQUAMOUS EPITHELIAL CELLS. It may also occur in sites where glandular or columnar epithelium is normally present. (From Stedman, 25th ed)
- Disease identity & definition — NLM Medical Subject Headings (MeSH), public domain
- Clinical trials — ClinicalTrials.gov (U.S. National Library of Medicine)
- Research activity — Europe PMC (EMBL-EBI) + OpenAlex-derived paper links
- Related entities are derived from literature co-mention (studied together) — associative, not causal.