Avelumab Cetuximab and Palbociclib in Recurrent or Metastatic Head and Neck Squamous Cell Carcinoma
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- STATUS
- Recruiting
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- End date
- Jan 26, 2022
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- participants needed
- 24
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- sponsor
- Kathryn Gold
Summary
The purpose of the study is to find out if the study drugs Avelumab, Cetuximab, and Palbociclib will slow or stop your cancer from getting worse, and whether it causes side effects. The second purpose is to measure whether your cancer responds to the study drugs Avelumab, Cetuximab, and Palbociclib. The study drugs Avelumab, Cetuximab, and Palbociclib are types of drugs called a monoclonal antibody. Monoclonal antibodies are made to recognize, target, and bind to specific proteins on cells the building blocks making up your tissues.
Description
This is an open-label phase I trial with a 3+3 dose escalation design. All patients will receive avelumab, cetuximab, and palbociclib. This study will enroll patients with head and neck squamous cell carcinoma not amenable to curative intent therapy.
Treatment will be administered in 28 day cycles with a pre-defined dose escalation schedule.
Details
| Condition | Squamous Cell Carcinoma of the Head and Neck, Head and Neck Squamous Cell Carcinoma, Squamous Cell Carcinoma of Head and Neck |
|---|---|
| Treatment | Cetuximab, Avelumab, Palbociclib |
| Clinical Study Identifier | NCT03498378 |
| Sponsor | Kathryn Gold |
| Last Modified on | 26 January 2021 |
How to participate?
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Additional screening procedures may be conducted by the study team before you can be confirmed eligible to participate.
Learn moreIf you are confirmed eligible after full screening, you will be required to understand and sign the informed consent if you decide to enroll in the study. Once enrolled you may be asked to make scheduled visits over a period of time.
Learn moreComplete your scheduled study participation activities and then you are done. You may receive summary of study results if provided by the sponsor.
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