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Monoclonal Antibodies

Avelumab + Cetuximab + Palbociclib for Head and Neck Cancer

Phase 1
Waitlist Available
Led By Kathryn A Gold, MD
Research Sponsored by Kathryn Gold
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Histologically or cytologically proven squamous cell carcinoma of the head and neck not amenable to curative intent therapy.
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up through study completion, an average of 3 years
Awards & highlights
No Placebo-Only Group

Summary

This trial is testing if Avelumab, Cetuximab, and Palbociclib can help treat people with solid tumors that have spread (metastasized).

Who is the study for?
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.
What is being tested?
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.
What are the potential side effects?
Potential side effects may include allergic reactions to the monoclonal antibodies, fatigue due to immune system activation against the cancer cells, as well as possible impacts on blood counts leading to increased infection risk.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
Select...
My cancer in the head or neck area cannot be cured with surgery or radiation.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~through study completion, an average of 3 years
This trial's timeline: 3 weeks for screening, Varies for treatment, and through study completion, an average of 3 years for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
maximum tolerated dose
Secondary study objectives
Incidence of Treatment-Emergent Adverse Events [Safety and Tolerability]
Overall response rate
overall survival
+1 more

Awards & Highlights

No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.

Trial Design

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
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Avelumab
2017
Completed Phase 2
~2440
Palbociclib
2017
Completed Phase 3
~3880
Cetuximab
2011
Completed Phase 3
~2480

Find a Location

Who is running the clinical trial?

Kathryn GoldLead Sponsor
PfizerIndustry Sponsor
4,649 Previous Clinical Trials
17,744,352 Total Patients Enrolled
Kathryn A Gold, MDPrincipal InvestigatorUniversity of California, San Diego
~3 spots leftby Nov 2025
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