Immunotherapy for Head and Neck Cancer

Recruiting in Palo Alto (17 mi)

+2 other locations

Overseen by Douglas R. Adkins

Age: 18+

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Phase 2

Waitlist Available

Sponsor: Washington University School of Medicine

No Placebo Group

Prior Safety Data

Trial Summary

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.

Research Team

Douglas R. Adkins

Principal Investigator

Washington University School of Medicine

Eligibility Criteria

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

Measurable disease defined as lesions that can be accurately measured in at least one dimension

My cancer is in the mouth, throat, or voice box and is not related to HPV.

I am 18 years old or older.

Exclusion Criteria

I do not have any unmanaged ongoing illnesses.

A history of allergic reactions attributed to compounds of similar chemical or biologic composition to MK-3475 or other agents used in the study

I have received treatment for head and neck cancer before.

Treatment Details

Interventions

• Cisplatin (Platinum-containing Compound)
• Image-guided radiation therapy (Radiation)
• Intensity modulated radiation therapy (Radiation)
• MK-3475 (Checkpoint Inhibitor)
• Peripheral blood (Other)
• Surgery (Surgery)

Trial Overview The trial is testing MK-3475 (pembrolizumab), given before and after surgery, along with standard treatments including radiation therapy and cisplatin chemotherapy. The aim is to see if pembrolizumab can reduce the risk of cancer returning or spreading in high-risk patients.

Participant Groups

Group I: Cohort 2: Neoadjuvant MK-3475 Experimental Treatment 6 Interventions

-MK-3475 will be given once intravenously and then given again 21 days after dose 1 (14-24 days before standard of care surgery)

Group II: Cohort 1: Neoadjuvant MK-3475 and Adjuvant MK-3475 Experimental Treatment 7 Interventions

* MK-3475 will be given intravenously once approximately 2-3 weeks prior to standard of care surgery. * Adjuvant therapy will be dictated by surgical pathology and occurs after standard of care surgery and will consist of: * risk-based intensity modulated radiation therapy consisting of 60 Gy in 2 Gy once-daily fraction size (total of 30 fractions)once-daily fraction size (total of 30 fractions) * optional image-guided radiation therapy * risk-based cisplatin administered intravenously on Days 1, 22, and 43 of treatment course * MK-3475 will be given intravenously once every 3 weeks for a maximum of 6 doses if participant is considered high-risk based surgical pathology from standard of care surgery. These doses of MK-3475 will be given after surgery and after all acute toxicities of post-operative standard of care chemotherapy and radiation have resolved to grade 1 or less.

Cisplatin is already approved in Canada, Japan for the following indications:

Approved in Canada as Platinol for:

• Testicular cancer
• Ovarian cancer
• Cervical cancer
• Bladder cancer
• Head and neck cancer
• Esophageal cancer
• Lung cancer
• Mesothelioma
• Brain tumors
• Neuroblastoma

Approved in Japan as Platinol for:

• Testicular cancer
• Ovarian cancer
• Cervical cancer
• Bladder cancer
• Head and neck cancer
• Esophageal cancer
• Lung cancer
• Mesothelioma
• Brain tumors
• Neuroblastoma

Who Is Running the Clinical Trial?

Washington University School of Medicine

Lead Sponsor

Trials

2,027

Recruited

2,353,000+

David H. Perlmutter

Washington University School of Medicine

Chief Executive Officer since 2015

MD from Washington University School of Medicine

Paul Scheel

Washington University School of Medicine

Chief Medical Officer since 2022

MD from Washington University School of Medicine

Merck Sharp & Dohme LLC

Industry Sponsor

Trials

4,096

Recruited

5,232,000+

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