Pembrolizumab + Radiotherapy for Head and Neck Cancer
Trial Summary
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 any form of immunosuppressive therapy, you may need to stop as these are part of the exclusion criteria.
What data supports the effectiveness of the treatment Pembrolizumab + Radiotherapy for Head and Neck Cancer?
Research shows that pembrolizumab, when used with radiotherapy, has shown promise in treating head and neck cancer, with studies indicating it can be safe and feasible. Pembrolizumab has also demonstrated antitumor activity in head and neck cancers, especially in tumors with high PD-L1 levels, suggesting it could be effective in combination with other treatments like radiotherapy.12345
Is the combination of pembrolizumab and radiotherapy safe for treating head and neck cancer?
Pembrolizumab, when used for head and neck cancer, has been found to be generally safe, but it can cause serious side effects like pneumonia (lung infection), breathing difficulties, confusion, vomiting, and immune system-related issues such as inflammation of the lungs, liver, and intestines. Combining it with radiotherapy has been shown to be safe and feasible in early studies.12678
How is the drug pembrolizumab combined with radiotherapy unique for treating head and neck cancer?
Pembrolizumab, an immune checkpoint inhibitor, is unique because it enhances the body's immune response against cancer cells and is used in combination with radiotherapy to potentially improve outcomes for patients with locally advanced head and neck cancer, especially those who cannot tolerate standard chemotherapy like cisplatin.126910
What is the purpose of this trial?
This is a randomized, active-controlled, open-label study of pembrolizumab (Pembro) given prior to surgery and pembrolizumab in combination with standard of care radiotherapy (with or without cisplatin), as post-surgical therapy in treatment naïve participants with newly diagnosed Stage III/IVA, resectable, locoregionally advanced, head and neck squamous cell carcinoma (LA-HNSCC). Efficacy outcomes will be stratified by programmed cell death ligand 1 (PD-L1) combined positive score (CPS) status. The primary hypothesis is that pembrolizumab given before surgery and after surgery in combination with radiotherapy (with or without cisplatin) improves event-free survival compared to radiotherapy (with or without cisplatin) given after surgery alone.
Research Team
Medical Director
Principal Investigator
Merck Sharp & Dohme LLC
Eligibility Criteria
This trial is for adults with newly diagnosed, resectable Stage III/IVA head and neck squamous cell carcinoma. Participants must not be pregnant or breastfeeding, agree to use contraception, have no prior anti-PD-1/L1/L2 therapy or cancer treatment, no live vaccines in the last 30 days, and no immunosuppressive conditions.Inclusion Criteria
Exclusion Criteria
Timeline
Screening
Participants are screened for eligibility to participate in the trial
Neoadjuvant Treatment
Participants receive 200 mg pembrolizumab by IV infusion on Day 1 of a 21-day cycle for 2 cycles prior to surgery
Surgery
Participants undergo surgical resection of the tumor
Adjuvant Treatment
High risk participants receive pembrolizumab, radiotherapy, and cisplatin; low risk participants receive pembrolizumab and radiotherapy
Follow-up
Participants are monitored for safety and effectiveness after treatment
Treatment Details
Interventions
- Cisplatin
- Pembrolizumab
- Radiotherapy
Pembrolizumab is already approved in United States, European Union, United Kingdom for the following indications:
- Head and neck squamous cell carcinoma (HNSCC) with PD-L1 CPS ≥1
- Melanoma
- Non-small cell lung cancer (NSCLC)
- Urothelial carcinoma
- Colorectal cancer
- Gastric cancer
- Hepatocellular carcinoma
- Renal cell carcinoma
- Cervical cancer
- Endometrial carcinoma
- Head and neck squamous cell carcinoma (HNSCC) with PD-L1 CPS ≥1
- Melanoma
- Non-small cell lung cancer (NSCLC)
- Urothelial carcinoma
- Colorectal cancer
- Gastric cancer
- Hepatocellular carcinoma
- Renal cell carcinoma
- Cervical cancer
- Endometrial carcinoma
- Untreated metastatic or unresectable recurrent head and neck squamous cell carcinoma (HNSCC) with PD-L1 CPS ≥1
Find a Clinic Near You
Who Is Running the Clinical Trial?
Merck Sharp & Dohme Corp.
Lead Sponsor
Chirfi Guindo
Merck Sharp & Dohme Corp.
Chief Medical Officer
Engineering degree from Ecole Centrale de Paris, MBA from New York University Stern School of Business
Robert M. Davis
Merck Sharp & Dohme Corp.
Chief Executive Officer since 2021
J.D. from Northwestern University Pritzker School of Law, MBA from Northwestern University Kellogg Graduate School of Management, Bachelor's in Finance from Miami University
Merck Sharp & Dohme LLC
Lead 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