Neoadjuvant Study of PD-1 Inhibitor Pembrolizumab in PD-1 Naive Cutaneous Squamous Cell Carcinoma (cSCC)
Active, enrolledPhase 2Results postedLast updated 29 May 2025
What this trial tests
Phase 2 trial testing Pembrolizumab Injection in Squamous Cell Carcinoma in 30 participants. Participants enrolled and being followed up; not accepting new ones.
18 and older, any sex, with Squamous Cell Carcinoma. Patients with the condition only — healthy volunteers not accepted.
Results — posted to ClinicalTrials.gov
Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.
Pathologic ResponsePrimary· At time of surgery, up to 6 weeks post-baseline
Percentage of patients with either pathologic complete response (pCR) or partial pathologic response (pPR) per Immune-Related Pathologic Response Criteria (immunotherapy-specific pathologic response criteria (irPRC) criteria. Per (irPRC), pCR = 0% residual viable tumor (RVT) remaining in post-therapy specimen (no signs of cancer) in tissue samples removed during surgery, and pPR = \>10% but ≤50% RVT remaining in post-therapy specimen in tissue samples removed during surgery.
pCR
Group
Value
95% CI
Pembrolizumab
63.0
42.4 – 80.6
pPR
Group
Value
95% CI
Pembrolizumab
7.4
0.9 – 24.3
Response Assessment Per Immune-Related Pathologic Response Criteria (irPRC)Primary· At time of surgery
Number of patients with pathologic complete response (pCR), partial pathologic response (pPR), pathologic non-response (pNR) per Immune-Related Pathologic Response Criteria ((irPRC) criteria. Per (irPRC), pCR = 0% residual viable tumor (RVT) (no signs of cancer), pPR = \>10% but ≤50% RVT, or pNR = \>50% RVT remaining in post-therapy specimen tissue samples removed during surgery.
pCR
Group
Value
95% CI
Pembrolizumab
17
pPR
Group
Value
95% CI
Pembrolizumab
2
pNR
Group
Value
95% CI
Pembrolizumab
8
Adverse events — posted to ClinicalTrials.gov
Time frame: Adverse Events data collected for a total of approximately 45 months for the study population. Up to approximately 16 months after start of treatment for individuals..
Reporting threshold: 0%.
Adverse-event reports describe events observed during the trial — not all are caused by the drug.
Pembrolizumab
Serious: 13/30 (43%)
Deaths: 6/30
Serious adverse events (22 terms)
Reaction
System
Pembrolizumab
Urinary tract infection
Infections and infestations
—
Pneumothorax
Respiratory, thoracic and mediastinal disorders
—
Respiratory failure
Respiratory, thoracic and mediastinal disorders
—
Cardiac arrest
Cardiac disorders
—
Heart failure
Cardiac disorders
—
Mobitz (type) II atrioventricular block
Cardiac disorders
—
Myocardial infarction
Cardiac disorders
—
Myocarditis
Cardiac disorders
—
GI bleed
Gastrointestinal disorders
—
Pain
General disorders
—
Hepatitis viral
Infections and infestations
—
COVID-19
Infections and infestations
—
Fall
Injury, poisoning and procedural complications
—
Blood bilirubin increased
Investigations
—
Hypercalcemia
Metabolism and nutrition disorders
—
metabolic encephalopathy
Nervous system disorders
—
nephritis
Renal and urinary disorders
—
Aspiration
Respiratory, thoracic and mediastinal disorders
—
Dyspnea
Respiratory, thoracic and mediastinal disorders
—
Pneumonitis
Respiratory, thoracic and mediastinal disorders
—
skin graft surgery
Surgical and medical procedures
—
Thromboembolic event
Vascular disorders
—
Other adverse events (154 terms — click to expand)
This phase II single-arm two-stage neoadjuvant study of pembrolizumab in patients with PD-1 naïve high-risk resectable cutaneous squamous cell carcinoma (cSCC) will be conducted over a 52-week period. The study will include patients who have not undergone surgery to remove disease, to formally evaluate whether both biologically and clinically high-risk disease may benefit from neoadjuvant anti-PD-1 therapy. Response to neoadjuvant anti-PD-1 therapy will be evaluated for association with improved landmark Relapse-free Survival (RFS).
Publications & conference data
8 peer-reviewed publications reference this trial (live from Europe PMC):
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· Phase 1, PHASE2
· not yet recruiting
NCT05899608 — Clinical Study of Ivonescimab for First-line Treatment of Metastatic NSCLC Patients
· Phase 3
· recruiting
NCT04387461 — Study of CG0070 Given in Combination With Pembrolizumab, in Non-Muscle Invasive Bladder Cancer, Unresponsive to Bacillus
· Phase 2
· completed
NCT04435197 — Pre-Operative Pembrolizumab + Chemoradiation in Patients With Locally Advanced Esophageal Squamous Cell Carcinoma
· Phase 2
· completed
NCT04089904 — Phase II Trial of Neoadjuvant Pembrolizumab for Patients With Early Stage Gastroesophageal Adenocarcinoma
· Phase 2
· terminated
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Currently open trials in the same condition.
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NCT07223424 — Patient Preference for Subcutaneous vs. Intravenous Immune Therapy
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NCT07095608 — Defining TRPV4 Contribution of Schwann Cells to Oral Cancer Pain
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NCT06996249 — Prospective Data Collection Initiative on Thoracic Malignancies
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Other Diwakar Davar trials
Trials by the same sponsor.
NCT07223424 — Patient Preference for Subcutaneous vs. Intravenous Immune Therapy
· Phase 2
· recruiting
Publications: Europe PMC API search by NCT ID, retrieved 10 June 2026
Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
Sponsor: as reported to ClinicalTrials.gov by Diwakar Davar
Last refreshed: 29 May 2025
Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT04808999.