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Preoperative Pembrolizumab and Chemotherapy in Resectable, Recurrent HNSCC

StatusRecruiting
PhasePhase 2
Started2023-05-20
View on ClinicalTrials.gov ↗

Amendment history

2026-06-21
Study Status v5
Re-verified, no change to tracked fields
2025-06-18
Study Status v4
Primary completion date2025-05-20→2027-12-31
2025-05-06
Study Status, Study Description, Conditions, Arms and Interventions, Eligibility v3
Eligibility criteria+299 characters
[...] nally recurrent squamous cell carcinoma of the head and neck, or second primary HNSCC in a previously irradiated field, defined as >50% of the presurgical tumor volume having prior radiation dose of >45 Gy as determined by the treating radiation oncologist (including primary sites, such as oral cavity, oropharynx, [...] ypopharynx carcinoma). Participants must be a candidate for salvagecurative intent surgery. Participants must have documented time of ≥ 6 mont [...] ed therapy) to diagnosis of local or locoregional recurrence or a second primary in a previously irradiated field. Participants must be willin [...] [...]
Study description+118 characters
[...] umab, cisplatin (or carboplatin), and docetaxel followed by salvage surgery followed by adjuvant pembrolizumab therapy in patien [...] rrent squamous cell carcinoma of the head and neck (HNSCC). This study will also include individuals with new HNSCC which developed in a field that has received prior radiation therapy. Pembrolizumab works by helping the immune system to fight HN [...]
2024-10-14
Study Status v2
Re-verified, no change to tracked fields
2023-10-03
Not Yet Recruiting→Recruiting Study Status, Contacts/Locations v1
Trial statusNot Yet Recruiting→Recruiting
Primary completion date2025-02-20→2025-05-20
Completion date2030-02-20→2030-05-20
Start dateestimated 2023-07→confirmed 2023-05-20
Study sitesdetails revised at 2 of 2 sites
2023-02-11
Original filing
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)
Trial Details
NCT Number NCT05726370
Lead Sponsor Dana-Farber Cancer Institute
Collaborators: Merck Sharp & Dohme LLC
Conditions Head and Neck Squamous Cell Carcinoma, Head and Neck Cancer, Resectable Head and Neck Squamous Cell Carcinoma, Recurrent Head and Neck Squamous Cell Carcinoma, Second Primary Squamous Cell Carcinoma of the Head and Neck
Enrollment 28 participants
Start Date 2023-05-20
Primary Completion 2027-12-31 (estimated)
Study Completion 2030-05-20 (estimated)
Updated on ClinicalTrials.gov 2026-06-23