OncoMatch/Clinical Trials/NCT05726370
Preoperative Pembrolizumab and Chemotherapy in Resectable, Recurrent HNSCC
Is NCT05726370 recruiting? Yes, currently enrolling (May 2026). This Phase 2 trial studies multiple treatments including Pembrolizumab and CISPLATIN for head and neck squamous cell carcinoma.
Treatment: Pembrolizumab · CISPLATIN · Carboplatin · Docetaxel — This research study is evaluating effectiveness and safety of a combination of immunotherapy drug, pembrolizumab, with chemotherapy, as a possible treatment before and after surgery for squamous cell carcinoma of the head and neck (HNSCC). The combination of pembrolizumab and chemotherapy will be given prior to your surgery, while immunotherapy pembrolizumab will be continued for approximately 1 year after surgery. The names of the study drugs involved in this research study are: * pembrolizumab (a type of immunotherapy) * docetaxel (a type of chemotherapy) * cisplatin (a type of chemotherapy) * carboplatin (a type of chemotherapy)
Check if I qualifyExtracted eligibility criteria
Cancer type
Head and Neck Squamous Cell Carcinoma
Biomarker criteria
Allowed: HPV any status
Participants may have any Human Papilloma Virus (HPV) status of the tumor. Patients with oropharyngeal cancer are required to undergo HPV testing with p16 immunohistochemistry and/or confirmatory HPV PCR or ISH testing
Performance status
ECOG 0–1(Restricted strenuous activity)
Prior therapy
Must have received: curative intent treatment for HNSCC (surgery and/or radiation therapy with/without platinum chemotherapy or cetuximab targeted therapy) (platinum chemotherapy, cetuximab) — curative intent
documented time of ≥ 6 months from completion of prior curative intent treatment for HNSCC (surgery and/or radiation therapy with/without platinum chemotherapy or cetuximab targeted therapy) to diagnosis of local or locoregional recurrence or a second primary in a previously irradiated field
Cannot have received: chemotherapy or radiotherapy for HNSCC in curative intent setting
Has had chemotherapy or radiotherapy for HNSCC in curative intent setting within 6 months prior to entering the study.
Cannot have received: anti-PD-1 therapy
Has received prior therapy with an anti-PD-1, anti-PD-L1, or anti PD L2 agent or with an agent directed to another stimulatory or co-inhibitory T-cell receptor (eg, CTLA-4, OX 40, CD137).
Lab requirements
Blood counts
leukocytes ≥3,000/mcL; absolute neutrophil count ≥1,500/mcL; platelets ≥100,000/mcL
Kidney function
creatinine ≤ institutional ULN OR glomerular filtration rate (GFR) ≥50 mL/min/1.73 m2 unless data exists supporting safe use at lower kidney function values, no lower than 30 mL/min/1.73 m2
Liver function
total bilirubin ≤ institutional upper limit of normal (ULN); AST(SGOT)/ALT(SGPT) ≤3 × institutional ULN
Cardiac function
Participants with known history or current symptoms of cardiac disease, or history of treatment with cardiotoxic agents, should have a clinical risk assessment of cardiac function using the New York Heart Association Functional Classification. To be eligible for this trial, participants should be class 2B or better.
Participants must have adequate organ and marrow function as defined below: leukocytes ≥3,000/mcL; absolute neutrophil count ≥1,500/mcL; platelets ≥100,000/mcL; total bilirubin ≤ institutional upper limit of normal (ULN); AST(SGOT)/ALT(SGPT) ≤3 × institutional ULN; creatinine ≤ institutional ULN OR glomerular filtration rate (GFR) ≥50 mL/min/1.73 m2 unless data exists supporting safe use at lower kidney function values, no lower than 30 mL/min/1.73 m2. Cardiac: NYHA class 2B or better.
Structured fields extracted by AI. May contain errors — verify against the official protocol.
US trial sites
- Brigham and Women's Hospital · Boston, Massachusetts
- Dana-Farber Cancer Institute · Boston, Massachusetts
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