Actively Recruiting
A Phase 2 Study of Preoperative Pembrolizumab and Chemotherapy Followed by Adjuvant Pembrolizumab in Resectable Locoregionally Recurrent Head and Neck Squamous Cell Carcinoma
Led by Dana-Farber Cancer Institute · Updated on 2025-06-22
28
Participants Needed
2
Research Sites
124 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
Researchers are evaluating the effectiveness and safety of combining pembrolizumab, an immunotherapy drug, with chemotherapy as treatment before and after surgery in people with squamous cell carcinoma of the head and neck (HNSCC). This phase II study focuses on patients with resectable recurrent HNSCC or new HNSCC in areas that have previously received radiation. Pembrolizumab helps the immune system fight this cancer type, and this research also includes individuals whose tumors developed in previously irradiated fields. Participants will receive two cycles of neoadjuvant treatment consisting of pembrolizumab combined with cisplatin or carboplatin and docetaxel chemotherapy before surgery. Surgery to remove the tumor and/or lymph nodes will occur 3 to 6 weeks after the second treatment cycle. Following surgery, participants will receive up to 15 cycles of pembrolizumab alone every 21 days for approximately one year as adjuvant therapy. The study treatment involves intravenous infusions and includes mandatory biopsies at baseline and blood and tissue sample collections. During the study, participants will undergo screening to confirm eligibility, regular evaluations, radiologic scans, and tumor biopsies. Researchers will measure the rate of major pathological response two months after treatment. They will also monitor treatment-related side effects, overall survival, disease-free survival, and radiological response before salvage surgery. The total study participation may last up to five years, including follow-up appointments to assess long-term outcomes and safety.
CONDITIONS
Brief 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
- Candidate for curative intent surgery
- At least 6 months since completion of prior curative treatment for HNSCC to diagnosis of recurrence or second primary
- Willing to undergo mandatory pre-treatment biopsy and provide tissue and blood samples
- Any smoking history allowed
- Any HPV status; 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 in the protocol
- Cardiac function class 2B or better by NYHA classification if history of cardiac disease
- Women of child-bearing potential and men must agree to use contraception during and after study participation
- Ability to understand and sign informed consent
You will not qualify if you...
- Sinonasal, nasopharyngeal, or cutaneous primary site of squamous cell carcinoma
- Known distant metastatic disease, including brain metastases
- Chemotherapy or radiotherapy for HNSCC within 6 months prior to study entry
- 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 study drug dose
- Participation in another investigational study or device use within 4 weeks prior to study drug
- Immunodeficiency or chronic systemic steroid or immunosuppressive therapy within 7 days before study drug
- Active progressing additional malignancy requiring treatment within past 2 years
- History of allergic reactions to study agents
- Active autoimmune disease requiring systemic treatment within past 2 years
- History or current pneumonitis/interstitial lung disease requiring steroids
- Active infection requiring 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 trial cooperation
- Not recovered from prior anti-cancer therapy toxicities above grade 2 except alopecia
- History of allogeneic tissue or solid organ transplant
- Positive pregnancy test within 72 hours prior to study registration or breastfeeding women
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person) for screening and enrollment
Duration - Approximately 6 weeks (2 cycles of 21 days each)
Participants undergo mandatory baseline biopsy followed by neoadjuvant treatment with pembrolizumab, cisplatin (or carboplatin), and docetaxel in 2 cycles.
2 visits (one per treatment cycle, in-person)
Duration - Surgery occurs 3 to 6 weeks after second treatment cycle; immediate post-operative care duration varies
Participants have primary tumor resection and/or lymph node dissection surgery scheduled 3 to 6 weeks after the completion of neoadjuvant treatment.
1 visit for surgery plus post-operative care visits as needed
Duration - Up to 45 weeks (3 to 8 weeks after surgery plus up to 15 cycles of 21 days each)
Participants receive adjuvant pembrolizumab treatment for up to 15 cycles following surgery.
Approximately 15 visits (one per treatment cycle, in-person)
Duration - Up to 5 years
Participants attend follow-up appointments for ongoing monitoring after completion of adjuvant therapy, lasting up to 5 years.
Visits every six months for survival and disease monitoring
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
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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