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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
Adequate hematologic, hepatic, and renal function
Histologically or cytologically proven squamous cell carcinoma of the head and neck not amenable to curative intent therapy.
Timeline
Screening 3 weeks
Treatment Varies
Follow Up through study completion, an average of 3 years
Awards & highlights

Study 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.Check my eligibility
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.See study design
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
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My blood, liver, and kidney functions are all within normal ranges.
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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

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

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
2018
Completed Phase 2
~2450
Palbociclib
2017
Completed Phase 3
~3720
Cetuximab
2011
Completed Phase 3
~2480

Find a Location

Who is running the clinical trial?

Kathryn GoldLead Sponsor
PfizerIndustry Sponsor
4,556 Previous Clinical Trials
10,907,658 Total Patients Enrolled
Kathryn A Gold, MDPrincipal InvestigatorUniversity of California, San Diego

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

In what treatments is Avelumab routinely employed?

"Avelumab is a standard intervention for merkel cell carcinoma. Additionally, it has been employed to reduce the severity of breast cancer when complemented with radiation and pharmacotherapy."

Answered by AI

Has Avelumab obtained regulatory acceptance from the FDA?

"Given the limited clinical data supporting both safety and efficacy, our team at Power gave Avelumab a score of 1 on its risk assessment scale."

Answered by AI

What is the quota of participants involved with this research?

"Unfortunately, this clinical trial is not currently recruiting participants. It was initially posted on June 6th 2018 and last amended in February 16th 2022. However, there are 2675 trials searching for patients with malignant neoplasms and 346 studies enlisting Avelumab users that you may find suitable to apply for."

Answered by AI

Is there still room for participation in this experiment?

"According to clinicaltrials.gov, this medical trial has concluded its search for prospective patients. The study was first created on June 6th 2018 and last updated on February 16th 2022; however, there are over 3 thousand other trails that are still open for enrollment at the moment."

Answered by AI

What other experiments have been conducted using Avelumab as a treatment?

"Presently, there are 54 Phase 3 trials and a grand total of 346 clinical studies related to Avelumab. Mostly based in Dresden, Arizona, these research projects also involve 15172 different medical centres."

Answered by AI
~4 spots leftby Mar 2025