Actively Recruiting
Preoperative Pembrolizumab and Chemotherapy in Resectable, Recurrent HNSCC
Led by Dana-Farber Cancer Institute · Updated on 2025-06-22
28
Participants Needed
2
Research Sites
365 weeks
Total Duration
On this page
Sponsors
D
Dana-Farber Cancer Institute
Lead Sponsor
M
Merck Sharp & Dohme LLC
Collaborating Sponsor
AI-Summary
What this Trial Is About
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)
CONDITIONS
Official Title
Preoperative Pembrolizumab and Chemotherapy in Resectable, Recurrent HNSCC
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Histologically or cytologically confirmed locoregionally recurrent squamous cell carcinoma of the head and neck, or second primary HNSCC in a previously irradiated field with >50% of tumor volume previously receiving >45 Gy radiation
- Candidate for curative intent surgery
- At least 6 months since completion of prior curative treatment for HNSCC to diagnosis of local or locoregional recurrence or second primary
- Willing to undergo pre-treatment biopsy and provide blood and tissue samples before treatment and at surgery
- Any smoking history allowed
- Any HPV tumor status allowed; oropharyngeal cancer patients must have HPV testing
- Age 18 years or older
- ECOG performance status 0 or 1
- Adequate organ and marrow function as defined by blood counts and liver/kidney function tests
- Cardiac function classified as NYHA class 2B or better
- Agree to use adequate contraception during study and for 180 days after last treatment dose
- Male participants agree to use contraception during treatment and for 180 days after last dose and avoid sperm donation
- Female participants not pregnant, not breastfeeding, and either not of childbearing potential or agree to contraception
- Able to understand and willing to sign informed consent
You will not qualify if you...
- Sinonasal, nasopharyngeal, or cutaneous primary site of squamous cell carcinoma of the head and neck
- Known distant metastatic disease, including brain metastases
- Chemotherapy or radiotherapy for HNSCC within 6 months before entering study
- Prior therapy with anti-PD-1, anti-PD-L1, anti-PD-L2, or other T-cell receptor agents
- Live vaccine within 30 days before first dose; killed vaccines allowed
- Current or recent participation in investigational agent or device study within 4 weeks
- Immunodeficiency or chronic systemic steroid/immunosuppressive therapy within 7 days before first dose
- Known progressing additional malignancy requiring active treatment within past 2 years
- History of allergic reactions to study agents
- Active autoimmune disease requiring systemic treatment in past 2 years
- History or current pneumonitis/interstitial lung disease requiring steroids
- Active infection needing systemic therapy
- Known HIV infection
- Known active Hepatitis B or C infection
- Conditions or therapies that may interfere with study participation or results
- Psychiatric or substance abuse disorders interfering with cooperation
- Unresolved toxicities > Grade 2 from prior anti-cancer therapy except alopecia
- History of allogeneic tissue or solid organ transplant
- Female of childbearing potential with positive pregnancy test within 72 hours before registration or breastfeeding
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 2 locations
1
Brigham and Women's Hospital
Boston, Massachusetts, United States, 02215
Not Yet Recruiting
2
Dana-Farber Cancer Institute
Boston, Massachusetts, United States, 02215
Actively Recruiting
Research Team
K
Kartik Sehgal, MD
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
TREATMENT
Number of Arms
1
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