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

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ClinicalTrials.gov Identifier: NCT03498378
Recruitment Status : Recruiting
First Posted : April 13, 2018
Last Update Posted : September 20, 2018
Sponsor:
Collaborator:
Pfizer
Information provided by (Responsible Party):
Kathryn Gold, University of California, San Diego

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.

Condition or disease Intervention/treatment Phase
Head and Neck Squamous Cell Carcinoma Drug: Avelumab Drug: Palbociclib Drug: Cetuximab Phase 1

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.


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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 24 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Phase I Study of Avelumab, Palbociclib, and Cetuximab in Recurrent or Metastatic Head and Neck Squamous Cell Carcinoma
Actual Study Start Date : June 6, 2018
Estimated Primary Completion Date : August 2021
Estimated Study Completion Date : January 2022

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
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
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




Primary Outcome Measures :
  1. maximum tolerated dose [ Time Frame: 12 months ]
    maximum tolerated dose/recommended phase II dose.


Secondary Outcome Measures :
  1. Overall response rate [ Time Frame: through study completion, an average of 3 years ]
    Determined by RECIST 1.1

  2. progression free survival [ Time Frame: through study completion, an average of 3 years ]
  3. overall survival [ Time Frame: through study completion, an average of 3 years ]
  4. Incidence of Treatment-Emergent Adverse Events [Safety and Tolerability] [ Time Frame: through study completion, an average of 3 years ]
    Number of participants with treatment-related adverse events as assessed by CTCAE v4.0



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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).

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03498378


Contacts
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Contact: Kathryn A Gold, MD 858-822-5182 kagold@ucsd.edu

Locations
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United States, California
UC San Diego Moores Cancer Center Recruiting
La Jolla, California, United States, 92093
Contact: Kathryn Gold, MD         
Sponsors and Collaborators
Kathryn Gold
Pfizer
Investigators
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Principal Investigator: Kathryn A Gold, MD University of California, San Diego

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Responsible Party: Kathryn Gold, Assistant Clinical Professor of Medicine, University of California, San Diego
ClinicalTrials.gov Identifier: NCT03498378     History of Changes
Other Study ID Numbers: 171386
First Posted: April 13, 2018    Key Record Dates
Last Update Posted: September 20, 2018
Last Verified: September 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Kathryn Gold, University of California, San Diego:
Avelumab
Palbociclib
Cetuximab
Head and Neck Squamous Cell Carcinoma
cancer
Recurrent Head and Neck Squamous Cell Carcinoma
Metastatic Head and Neck Squamous Cell Carcinoma

Additional relevant MeSH terms:
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Carcinoma
Carcinoma, Squamous Cell
Squamous Cell Carcinoma of Head and Neck
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Neoplasms
Neoplasms, Squamous Cell
Head and Neck Neoplasms
Neoplasms by Site
Cetuximab
Palbociclib
Antibodies, Monoclonal
Antineoplastic Agents, Immunological
Antineoplastic Agents
Protein Kinase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Immunologic Factors
Physiological Effects of Drugs