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

NCT03498378

Last updated date
Study Location
UC San Diego Moores Cancer Center
La Jolla, California, 92093, United States
Contact
858-822-5182

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Eligibility Criteria
condition
The disease, disorder, syndrome, illness, or injury that is being studied.
Head and Neck Squamous Cell Carcinoma
Sex
Females and Males
Age
Pediatric Trials: 0-17 Years
Adult Trials: 18+ Years
18 + years
Inclusion Criteria
The factors, or reasons, that allow a person to participate in a clinical study.
Show details

- 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
The factors, or reasons, that prevent a person from participating in a clinical study.
Show details


- 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).

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Head and Neck Squamous Cell CarcinomaAvelumab, Cetuximab, and Palbociclib in Recurrent or Metastatic Head and Neck Squamous Cell Carcinoma
NCT03498378
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Advanced Information
Descriptive Information
Brief Title  ICMJE Avelumab, Cetuximab, and Palbociclib in Recurrent or Metastatic Head and Neck Squamous Cell Carcinoma
Official Title  ICMJE A Phase I Study of Avelumab, Palbociclib, and Cetuximab in Recurrent or Metastatic Head and Neck Squamous Cell Carcinoma
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.

Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 1
Study Design  ICMJE Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE Head and Neck Squamous Cell Carcinoma
Intervention  ICMJE
  • Drug: Avelumab
    Avelumab (IV on days 1 and 15 of 28 day cycle)
    Other Name: Bavencio
  • 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.

    Other Name: IBRANCE
  • 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.

    Other Name: ERBITUX
Study Arms  ICMJE Experimental: Avelumab, Palbociclib, and Cetuximab
Identify the maximum tolerated dose (MTD) or recommended phase II dose (RP2D) for the combination of palbociclib, avelumab, and cetuximab
Interventions:
  • Drug: Avelumab
  • Drug: Palbociclib
  • Drug: Cetuximab
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Recruiting
Estimated Enrollment  ICMJE
 (submitted: April 6, 2018)
24
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE January 2022
Estimated Primary Completion Date August 2021   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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).
Sex/Gender  ICMJE
Sexes Eligible for Study:All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE
Contact: Kathryn A Gold, MD858-822-5182[email protected]
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT03498378
Other Study ID Numbers  ICMJE 171386
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE
Plan to Share IPD:No
Responsible Party Kathryn Gold, University of California, San Diego
Study Sponsor  ICMJE Kathryn Gold
Collaborators  ICMJE Pfizer
Investigators  ICMJE
Principal Investigator:Kathryn A Gold, MDUniversity of California, San Diego
PRS Account University of California, San Diego
Verification Date October 2019

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP