Pembrolizumab + Epacadostat for Head and Neck Cancer
Trial Summary
Do I need to stop my current medications to join the trial?
The trial protocol does not specify if you need to stop taking your current medications. However, it mentions the use of protocol-defined prior/concomitant therapy, which might mean some medications could be restricted. It's best to discuss your specific medications with the trial team.
What data supports the effectiveness of the drug combination Pembrolizumab + Epacadostat for head and neck cancer?
Research shows that Pembrolizumab, a drug that helps the immune system fight cancer, is approved for use in head and neck cancer after other treatments have failed. Additionally, combinations of drugs like cisplatin or carboplatin with 5-fluorouracil and cetuximab have been shown to be effective in treating head and neck cancer, suggesting that similar combinations may also be beneficial.12345
Is the combination of pembrolizumab and epacadostat safe for head and neck cancer patients?
The combination of pembrolizumab with other drugs like carboplatin and paclitaxel has been generally well tolerated in patients with head and neck cancer, though some experienced mild to moderate side effects like anemia (low red blood cell count) and hypertension (high blood pressure). Safety data specifically for pembrolizumab and epacadostat together is limited, but pembrolizumab alone has been approved for use in similar conditions, indicating a level of safety in humans.13567
What makes the drug combination of Pembrolizumab and Epacadostat unique for head and neck cancer?
This drug combination is unique because it combines Pembrolizumab, an immune checkpoint inhibitor that blocks PD-1 to help the immune system attack cancer cells, with Epacadostat, an IDO inhibitor that may enhance immune response by reducing immune suppression. This approach is novel compared to traditional chemotherapy, which often has more side effects and less targeted action.138910
What is the purpose of this trial?
The purpose of this study was to evaluate the efficacy and safety of pembrolizumab plus epacadostat, pembrolizumab monotherapy, and the EXTREME regimen (cetuximab + cisplatin or carboplatin + 5-fluorouracil) as first-line treatment for recurrent or metastatic head and neck squamous cell carcinoma (HNSCC).
Research Team
Mark Jones, MD
Principal Investigator
Incyte Corporation
Eligibility Criteria
This trial is for adults with recurrent or metastatic head and neck squamous cell carcinoma who have measurable disease, are in good physical condition (ECOG 0-1), have proper organ function, and can provide a tumor specimen. It's not for those with recent other cancers, active autoimmune diseases treated within the last 2 years, HIV or hepatitis B/C infections, CNS metastases, or certain types of head and neck cancer.Inclusion Criteria
Exclusion Criteria
Timeline
Screening
Participants are screened for eligibility to participate in the trial
Treatment
Participants receive pembrolizumab plus epacadostat, pembrolizumab monotherapy, or the EXTREME regimen as first-line treatment for recurrent or metastatic head and neck squamous cell carcinoma
Follow-up
Participants are monitored for safety and effectiveness after treatment
Treatment Details
Interventions
- 5-Fluorouracil
- Carboplatin
- Cetuximab
- Cisplatin
- Epacadostat
- Pembrolizumab
5-Fluorouracil is already approved in European Union, United States, Canada, Japan for the following indications:
- Colorectal cancer
- Breast cancer
- Stomach cancer
- Pancreatic cancer
- Ovarian cancer
- Colorectal cancer
- Breast cancer
- Stomach cancer
- Pancreatic cancer
- Colorectal cancer
- Breast cancer
- Stomach cancer
- Colorectal cancer
- Breast cancer
- Stomach cancer
- Pancreatic cancer
Find a Clinic Near You
Who Is Running the Clinical Trial?
Incyte Corporation
Lead Sponsor
Steven Stein
Incyte Corporation
Chief Medical Officer since 2015
MD from University of Witwatersrand
Hervé Hoppenot
Incyte Corporation
Chief Executive Officer since 2014
MBA from ESSEC Business School
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