Avelumab + Cetuximab + Palbociclib for Head and Neck Cancer

Recruiting in Palo Alto (17 mi)

Overseen byKathryn A Gold, MD

Age: 18+

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Phase 1

Waitlist Available

Sponsor: Kathryn Gold

No Placebo Group

Breakthrough Therapy

Trial Summary

What is the purpose of this trial?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.

Eligibility Criteria

This trial is for people with certain types of head and neck cancer that can't be cured by surgery or radiation. Participants must have a life expectancy over 12 weeks, good blood, liver, and kidney function, not be pregnant if capable of bearing children, and have tumors that can be measured.

Inclusion Criteria

You have tumors that can be measured according to specific criteria.

My blood, liver, and kidney functions are all within normal ranges.

My cancer in the head or neck area cannot be cured with surgery or radiation.

+2 more

Participant Groups

The study tests whether the drugs Avelumab, Cetuximab, and Palbociclib slow down or stop cancer growth in patients with recurrent or metastatic head and neck squamous cell carcinoma. These drugs are monoclonal antibodies designed to target specific proteins on cancer cells.

1Treatment groups

Experimental Treatment

Group I: Avelumab, Palbociclib, and CetuximabExperimental Treatment3 Interventions

Identify the maximum tolerated dose (MTD) or recommended phase II dose (RP2D) for the combination of palbociclib, avelumab, and cetuximab

Avelumab is already approved in European Union, United States, Japan for the following indications:

🇪🇺 Approved in European Union as Bavencio for: