Cetuximab + Nivolumab for Head and Neck Cancer
Trial Summary
Will I have to stop taking my current medications?
The trial does not specify if you need to stop taking your current medications. However, you cannot have had chemotherapy, biological therapy, or radiation within 4 weeks before joining the study, and you must not be on certain immunosuppressive medications within 14 days of starting the trial.
What data supports the effectiveness of the drug Cetuximab for head and neck cancer?
Is the combination of Cetuximab and Nivolumab safe for humans?
How is the drug combination of Cetuximab and Nivolumab unique for head and neck cancer?
The combination of Cetuximab and Nivolumab is unique because Cetuximab targets the epidermal growth factor receptor (EGFR), which is important in cancer growth, while Nivolumab is an immune checkpoint inhibitor that helps the immune system attack cancer cells. This dual approach may offer a novel way to improve treatment outcomes compared to traditional therapies.15101112
What is the purpose of this trial?
The purpose of this study is to find out if the combination of two established anti-cancer therapies are beneficial in participants with Head and Neck Squamous Cell Carcinoma (HNSCC). Specifically, investigators want to determine if the combination of Cetuximab and nivolumab can help people with advanced cases of HNSCC. Both cetuximab and nivolumab have been used separately to treat HNSCC and are Food and Drug Administration (FDA) approved in this type of cancer.
Research Team
Christine H. Chung, M.D.
Principal Investigator
H. Lee Moffitt Cancer Center and Research Institute
Eligibility Criteria
Adults with advanced Head and Neck Squamous Cell Carcinoma (HNSCC) who have already tried at least one treatment like chemotherapy or radiation. They must be in good enough health to participate, not pregnant, and using effective contraception if sexually active. People can't join if they've had certain recent treatments, uncontrolled illnesses, severe allergies to similar drugs, or specific heart conditions.Inclusion Criteria
Exclusion Criteria
Timeline
Screening
Participants are screened for eligibility to participate in the trial
Phase I Treatment
Participants receive cetuximab and nivolumab every 2 weeks for 12 cycles or until discontinuation. Dose limiting toxicity assessment during Cycle 1.
Phase II Treatment
Participants receive cetuximab and nivolumab at the recommended Phase II dose.
Follow-up
Participants are monitored for safety and effectiveness after treatment. Imaging studies every 8 weeks during Cycle 1-6 and every 12 weeks during Cycle 7-12.
Treatment Details
Interventions
- Cetuximab
- Nivolumab
Cetuximab is already approved in United States, European Union for the following indications:
- Locally or regionally advanced squamous cell carcinoma of the head and neck
- Recurrent locoregional disease or metastatic squamous cell carcinoma of the head and neck
- K-Ras wild-type, EGFR-expressing, metastatic colorectal cancer
- BRAF V600E mutation-positive metastatic colorectal cancer
- Squamous cell carcinoma of the head and neck
- K-Ras wild-type, EGFR-expressing, metastatic colorectal cancer
Find a Clinic Near You
Who Is Running the Clinical Trial?
H. Lee Moffitt Cancer Center and Research Institute
Lead Sponsor
James and Esther King Biomedical Research Program
Collaborator
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
Bristol-Myers Squibb
Industry Sponsor
Christopher Boerner
Bristol-Myers Squibb
Chief Executive Officer since 2023
PhD in Business Administration from the Haas School of Business, University of California, Berkeley; BA in Economics and History from Washington University in St. Louis
Deepak L. Bhatt
Bristol-Myers Squibb
Chief Medical Officer since 2024
MD from Yale University; MSc in Clinical Epidemiology from the University of Pennsylvania