Pembrolizumab + Olaparib for Head and Neck Cancer
What You Need to Know Before You Apply
What is the purpose of this trial?
The purpose of this research study is to evaluate the effectiveness of using a combination of pembrolizumab and olaparib when given before and after standard chemoradiation therapy in treating locally advanced head and neck squamous cell carcinoma. Pembrolizumab and olaparib are drugs that are approved for head and neck cancer treatment. However, FDA has not approved the use of these two drugs together in treating head and neck cancer.
Will I have to stop taking my current medications?
The trial protocol does not specify whether you need to stop taking your current medications. However, if you are taking systemic glucocorticoids (a type of steroid medication), you may need to stop unless they are used for specific symptoms related to the study.
Is the combination of pembrolizumab and olaparib safe for head and neck cancer treatment?
Pembrolizumab has been studied in combination with other treatments for head and neck cancer and is generally considered safe, though it can cause side effects like anemia (low red blood cell count), stomatitis (mouth sores), and neutropenia (low white blood cell count). No treatment-related deaths were reported in the studies reviewed.12345
What makes the treatment with Pembrolizumab and Olaparib unique for head and neck cancer?
This treatment combines pembrolizumab, an immune checkpoint inhibitor that helps the immune system attack cancer cells, with olaparib, a drug that targets cancer cell DNA repair mechanisms. This combination is novel for head and neck cancer as it integrates immunotherapy with a targeted therapy, potentially enhancing the effectiveness of standard treatments like radiation and chemotherapy.23467
What data supports the effectiveness of the drugs pembrolizumab and olaparib for head and neck cancer?
Research shows that pembrolizumab, an immune checkpoint inhibitor, has demonstrated antitumor activity in recurrent and/or metastatic head and neck squamous cell carcinoma (HNSCC) and is approved for use in these cases. Additionally, combining pembrolizumab with chemoradiotherapy has been shown to be safe and feasible for locally advanced HNSCC, suggesting potential effectiveness in this context.23478
Who Is on the Research Team?
Siddharth Sheth, MD
Principal Investigator
UNC Lineberger Comprehensive Cancer Center
Are You a Good Fit for This Trial?
This trial is for adults over 18 with certain types of head and neck squamous cell carcinoma (HNSCC) that haven't been treated yet. Participants need to be in good physical condition, able to follow the study plan, and have a tumor assessable by imaging. They can't join if they've had other cancer treatments recently, can't swallow pills, are ineligible for cisplatin therapy, or have severe medical issues.Inclusion Criteria
Exclusion Criteria
Timeline for a Trial Participant
Screening
Participants are screened for eligibility to participate in the trial
Induction
Participants receive one infusion of pembrolizumab and take olaparib tablets for 21 days
Chemoradiation
Radiation therapy administered daily with weekly cisplatin infusion over 7 weeks
Maintenance
Pembrolizumab infusion every 6 weeks and olaparib tablets twice daily for up to 8 cycles
Follow-up
Participants are monitored for safety and effectiveness after treatment
What Are the Treatments Tested in This Trial?
Interventions
- Cisplatin
- External Beam Radiotherapy
- IMRT (intensity modulated radiation therapy)
- Olaparib
- Pembrolizumab
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?
UNC Lineberger Comprehensive Cancer Center
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