Cemiplimab + Cetuximab 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. It's best to discuss this with the trial coordinators or your doctor.
What data supports the effectiveness of the drug combination Cemiplimab + Cetuximab for head and neck cancer?
Cetuximab, when used with radiotherapy, has been shown to improve survival in patients with advanced squamous cell cancer of the head and neck. It enhances the effects of radiotherapy without increasing the usual side effects, making it a valuable option for patients who cannot undergo standard chemotherapy.12345
Is the combination of Cemiplimab and Cetuximab safe for humans?
How is the drug combination of Cemiplimab and Cetuximab unique for head and neck cancer?
The combination of Cemiplimab and Cetuximab is unique because it pairs an immune checkpoint inhibitor (Cemiplimab) with an epidermal growth factor receptor inhibitor (Cetuximab), potentially enhancing the immune system's ability to fight cancer while also targeting specific cancer cell growth pathways. This dual approach may offer a novel treatment option for head and neck cancer compared to traditional therapies.111121314
What is the purpose of this trial?
The purpose of the study is to determine if cemiplimab in combination with cetuximab given before their surgery are beneficial and safe in participants with head and neck squamous cell carcinoma (HNSCC).
Research Team
Christine Chung
Principal Investigator
Moffitt Cancer Center
Eligibility Criteria
Adults with head and neck squamous cell carcinoma (HNSCC) that can be surgically removed are eligible for this trial. They must have good performance status, meet lab criteria, provide tumor tissue for testing, agree to birth control if of childbearing potential, and commit to the study schedule. Excluded are those with severe allergies to similar drugs or red meat/tick bite history, HIV/Hepatitis B/C infections, certain heart conditions, active autoimmune diseases or pneumonitis.Inclusion Criteria
Exclusion Criteria
Timeline
Screening
Participants are screened for eligibility to participate in the trial
Neoadjuvant Treatment
Participants receive cemiplimab and cetuximab before surgery
Surgery
Participants undergo surgery for head and neck squamous cell carcinoma
Follow-up
Participants are monitored for safety and effectiveness after treatment
Treatment Details
Interventions
- Cemiplimab
- Cetuximab
Find a Clinic Near You
Who Is Running the Clinical Trial?
H. Lee Moffitt Cancer Center and Research Institute
Lead Sponsor
Regeneron Pharmaceuticals
Industry Sponsor
Leonard Schleifer
Regeneron Pharmaceuticals
Chief Executive Officer since 1988
MD and PhD in Medicine
George Yancopoulos
Regeneron Pharmaceuticals
Chief Medical Officer since 1997
MD from Harvard Medical School
Eli Lilly and Company
Industry Sponsor
Dr. Daniel Skovronsky
Eli Lilly and Company
Chief Medical Officer since 2018
MD from Harvard Medical School
David A. Ricks
Eli Lilly and Company
Chief Executive Officer since 2017
BSc from Purdue University, MBA from Indiana University