Avelumab, Cetuximab, and Palbociclib in Recurrent or Metastatic Head and Neck Squamous Cell Carcinoma

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

ACTIVE_NOT_RECRUITING

Clinical Phase

PHASE1

Total Enrollment

24 participants

Study Classification

INTERVENTIONAL

Study Start Date

2018-06-06

Study Completion Date

2025-12-30

Brief Summary

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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.

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Detailed Description

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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.

Conditions

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Head and Neck Squamous Cell Carcinoma

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Avelumab, Palbociclib, and Cetuximab

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Group Type EXPERIMENTAL

Avelumab

Intervention Type DRUG

Avelumab (IV on days 1 and 15 of 28 day cycle)

Palbociclib

Intervention Type DRUG

Palbociclib (PO daily, days 1-21 of 28 day cycle)

Palbociclib will be administered in capsules of 125 mg, 100 mg, and 75 mg, depending on dosage. Patients will be instructed to take their assigned dose once daily with food for 21 days followed by 7 days off therapy. Patients will be encouraged to take their dose at approximately the same time each day.

Cetuximab

Intervention Type DRUG

Cetuximab (IV 400 mg/m2 x 1, then weekly)

Cetuximab is administered intravenously once weekly via infusion pump or syringe pump with infusion rate not to exceed 10 mg/min.

Interventions

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Avelumab

Avelumab (IV on days 1 and 15 of 28 day cycle)

Intervention Type DRUG

Palbociclib

Palbociclib (PO daily, days 1-21 of 28 day cycle)

Palbociclib will be administered in capsules of 125 mg, 100 mg, and 75 mg, depending on dosage. Patients will be instructed to take their assigned dose once daily with food for 21 days followed by 7 days off therapy. Patients will be encouraged to take their dose at approximately the same time each day.

Intervention Type DRUG

Cetuximab

Cetuximab (IV 400 mg/m2 x 1, then weekly)

Cetuximab is administered intravenously once weekly via infusion pump or syringe pump with infusion rate not to exceed 10 mg/min.

Intervention Type DRUG

Other Intervention Names

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Bavencio IBRANCE ERBITUX

Eligibility Criteria

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Inclusion Criteria

* Histologically or cytologically proven squamous cell carcinoma of the head and neck not amenable to curative intent therapy.
* Presence of measurable tumor lesions per RECIST criteria v1.1
* Life expectancy greater than 12 weeks.
* Adequate hematologic, hepatic, and renal function
* Negative serum or urine pregnancy test for women of child bearing potential

Exclusion Criteria

* Prior therapy with an EGFR inhibitor or PD-1 or PD-L1 inhibitor in the recurrent or metastatic setting
* Uncontrolled central nervous system metastases (stable metastases permitted)
* Chemotherapy 28 days prior to first administration of study treatment and/or monoclonal antibody ≤8 weeks prior to first administration of study treatment.
* History of other malignancies,
* Concurrent systemic immunosuppressant therapy (eg, cyclosporine A, tacrolimus, etc., or chronic administration of \>10 mg/day of prednisone or equivalent)
* Prior organ transplantation
* Known history of human immunodeficiency virus (HIV) or active infection with hepatitis C virus (HCV) or hepatitis B virus (HBV).

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No