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

Primary Purpose

Head and Neck Squamous Cell Carcinoma

Status

Active

Phase

Phase 1

Locations

United States

Study Type

Interventional

Intervention

Avelumab

Palbociclib

Cetuximab

About this trial

This is an interventional treatment trial for Head and Neck Squamous Cell Carcinoma focused on measuring Avelumab, Palbociclib, Cetuximab, Head and Neck Squamous Cell Carcinoma, cancer, Recurrent Head and Neck Squamous Cell Carcinoma, Metastatic Head and Neck Squamous Cell Carcinoma

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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).

Sites / Locations

UC San Diego Moores Cancer Center

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Avelumab, Palbociclib, and Cetuximab

Arm Description

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

Outcomes

Primary Outcome Measures

maximum tolerated dose

maximum tolerated dose/recommended phase II dose.

Secondary Outcome Measures

Overall response rate

Determined by RECIST 1.1

progression free survival

overall survival

Incidence of Treatment-Emergent Adverse Events [Safety and Tolerability]

Number of participants with treatment-related adverse events as assessed by CTCAE v4.0

Full Information

NCT ID

NCT03498378

First Posted

March 27, 2018

Last Updated

March 1, 2023

Sponsor

Kathryn Gold

Collaborators

Pfizer

1. Study Identification

Unique Protocol Identification Number

NCT03498378

Brief Title

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

Official Title

A Phase I Study of Avelumab, Palbociclib, and Cetuximab in Recurrent or Metastatic Head and Neck Squamous Cell Carcinoma

Study Type

Interventional

2. Study Status

Record Verification Date

March 2023

Overall Recruitment Status

Active, not recruiting

Study Start Date

June 6, 2018 (Actual)

Primary Completion Date

February 4, 2020 (Actual)

Study Completion Date

July 2023 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor-Investigator

Name of the Sponsor

Kathryn Gold

Collaborators

Pfizer

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Yes

Studies a U.S. FDA-regulated Device Product

Data Monitoring Committee

Yes

5. Study Description

Brief 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.

Detailed 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Head and Neck Squamous Cell Carcinoma

Keywords

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

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 1

Interventional Study Model

Single Group Assignment

Masking

None (Open Label)

Allocation

N/A

Enrollment

24 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

Avelumab, Palbociclib, and Cetuximab

Arm Type

Experimental

Arm Description

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

Intervention Type

Drug

Intervention Name(s)

Avelumab

Other Intervention Name(s)

Bavencio

Intervention Description

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

Intervention Type

Drug

Intervention Name(s)

Palbociclib

Other Intervention Name(s)

IBRANCE

Intervention Description

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

Intervention Name(s)

Cetuximab

Other Intervention Name(s)

ERBITUX

Intervention Description

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.

Primary Outcome Measure Information:

Title

maximum tolerated dose

Description

maximum tolerated dose/recommended phase II dose.

Time Frame

12 months

Secondary Outcome Measure Information:

Title

Overall response rate

Description

Determined by RECIST 1.1

Time Frame

through study completion, an average of 3 years

Title

progression free survival

Time Frame

through study completion, an average of 3 years

Title

overall survival

Time Frame

through study completion, an average of 3 years

Title

Incidence of Treatment-Emergent Adverse Events [Safety and Tolerability]

Description

Number of participants with treatment-related adverse events as assessed by CTCAE v4.0

Time Frame

through study completion, an average of 3 years

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Accepts Healthy Volunteers

Eligibility Criteria

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).

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Kathryn A Gold, MD

Organizational Affiliation

University of California, San Diego

Official's Role

Principal Investigator

Facility Information:

Facility Name

UC San Diego Moores Cancer Center

City

La Jolla

State/Province

California

ZIP/Postal Code

92093

Country

United States

12. IPD Sharing Statement

Plan to Share IPD

Citations:

PubMed Identifier

36279618

Citation

Dennis MJ, Sacco AG, Qi Y, Bykowski J, Pittman E, Chen R, Messer K, Cohen EEW, Gold KA. A phase I study of avelumab, palbociclib, and cetuximab in patients with recurrent or metastatic head and neck squamous cell carcinoma. Oral Oncol. 2022 Dec;135:106219. doi: 10.1016/j.oraloncology.2022.106219. Epub 2022 Oct 21.

Results Reference

derived

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

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