Immunotherapy for Head and Neck Cancer
What You Need to Know Before You Apply
What is the purpose of this trial?
The goal of this trial is to test the ability of MK-3475 (pembrolizumab) to improve locoregional recurrence and distant metastatic rates in high-risk patients with locally advanced head and neck squamous cell carcinomas (HNSCCs) that are treated with current standard of care surgical approaches.
Will I have to stop taking my current medications?
The trial information does not specify if you need to stop taking your current medications. However, if you are on systemic steroid therapy or immunosuppressive drugs, you may need to stop them before starting the trial.
Is immunotherapy for head and neck cancer generally safe for humans?
How is the treatment with Cisplatin, Image-guided radiation therapy, and Surgery unique for head and neck cancer?
This treatment combines Cisplatin, a chemotherapy drug known for its effectiveness in head and neck cancer, with image-guided radiation therapy and surgery, offering a comprehensive approach that targets the cancer from multiple angles. Cisplatin is a standard treatment but can cause hearing loss, and this combination aims to enhance effectiveness while managing side effects.16789
What data supports the effectiveness of the drug Cisplatin in treating head and neck cancer?
Who Is on the Research Team?
Douglas R. Adkins
Principal Investigator
Washington University School of Medicine
Are You a Good Fit for This Trial?
Adults with stage III or IV head and neck squamous cell carcinoma (excluding HPV-positive types) who are fit for surgery, have not had prior treatment for this cancer, and meet certain health criteria like normal organ function. Participants must be willing to use two forms of contraception during the study.Inclusion Criteria
Exclusion Criteria
Timeline for a Trial Participant
Screening
Participants are screened for eligibility to participate in the trial
Neoadjuvant Treatment
MK-3475 is administered intravenously once approximately 2-3 weeks prior to standard of care surgery
Surgery
Standard of care surgery is performed
Adjuvant Treatment
Adjuvant therapy including risk-based radiation and chemotherapy, and MK-3475 administered every 3 weeks for up to 6 doses
Follow-up
Participants are monitored for safety and effectiveness after treatment
What Are the Treatments Tested in This Trial?
Interventions
- Cisplatin
- Image-guided radiation therapy
- Intensity modulated radiation therapy
- MK-3475
- Peripheral blood
- Surgery
Cisplatin is already approved in European Union, United States, Canada, Japan for the following indications:
Find a Clinic Near You
Who Is Running the Clinical Trial?
Washington University School of Medicine
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