Immunotherapy + Chemotherapy for Resectable Head and Neck Cancer
What You Need to Know Before You Apply
What is the purpose of this trial?
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)
Do I need to stop my current medications to join the trial?
The trial information does not specify if you need to stop taking your current medications. However, if you are on immunosuppressive therapy or have recently received certain vaccines, you may need to discuss this with the trial team.
Is the combination of immunotherapy and chemotherapy safe for head and neck cancer?
The combination of pembrolizumab (an immunotherapy drug) with carboplatin and paclitaxel (chemotherapy drugs) was generally well tolerated in a small study of patients with head and neck cancer, although all patients experienced mild side effects, and 30% had more serious side effects like anemia (low red blood cell count) and high blood pressure.12345
How is the drug combination of immunotherapy and chemotherapy unique for treating resectable head and neck cancer?
This treatment combines immunotherapy (pembrolizumab) with chemotherapy drugs (carboplatin, cisplatin, and docetaxel), which is unique because it leverages the immune system to target cancer cells while also using chemotherapy to directly kill them. This combination aims to improve outcomes by enhancing the body's immune response against cancer, which is different from traditional chemotherapy alone.12678
What data supports the effectiveness of the drug combination used in the clinical trial for head and neck cancer?
Who Is on the Research Team?
Kartik Sehgal
Principal Investigator
Dana-Farber Cancer Institute
Are You a Good Fit for This Trial?
Adults with recurrent head and neck squamous cell carcinoma (HNSCC) eligible for surgery, not pregnant or breastfeeding, willing to use contraception. Must have good organ function, no recent immunotherapy or live vaccines, no other active cancers or severe autoimmune diseases. No prior treatment within 6 months and must be able to provide tissue samples.Inclusion Criteria
Exclusion Criteria
Timeline for a Trial Participant
Screening
Participants are screened for eligibility to participate in the trial
Preoperative Treatment
Participants receive neoadjuvant treatment with Pembrolizumab, Cisplatin (or Carboplatin), and Docetaxel for 2 cycles
Salvage Surgery
Primary tumor resection and/or lymph node dissection surgery
Adjuvant Treatment
Participants receive adjuvant Pembrolizumab therapy for up to 15 cycles
Follow-up
Participants are monitored for safety and effectiveness after treatment
What Are the Treatments Tested in This Trial?
Interventions
- Carboplatin
- Cisplatin
- Docetaxel
- Pembrolizumab
Carboplatin is already approved in United States, European Union, Canada for the following indications:
Find a Clinic Near You
Who Is Running the Clinical Trial?
Dana-Farber Cancer Institute
Lead Sponsor
Merck Sharp & Dohme LLC
Industry Sponsor
Chirfi Guindo
Merck Sharp & Dohme LLC
Chief Marketing Officer since 2022
Degree in Engineering from Ecole Centrale de Paris, MBA from New York University Stern School of Business
Robert M. Davis
Merck Sharp & Dohme LLC
Chief Executive Officer since 2021
JD from Northwestern University Pritzker School of Law, MBA from Northwestern University Kellogg Graduate School of Management, Bachelor's in Finance from Miami University