Clinical Trials /

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

NCT03498378

Description:

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.

Related Conditions:
  • Head and Neck Squamous Cell Carcinoma
Recruiting Status:

Recruiting

Phase:

Phase 1

Trial Eligibility

Document

Title

  • 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

Clinical Trial IDs

  • ORG STUDY ID: 171386
  • NCT ID: NCT03498378

Conditions

  • Head and Neck Squamous Cell Carcinoma

Interventions

DrugSynonymsArms
AvelumabBavencioAvelumab, Palbociclib, and Cetuximab
PalbociclibIBRANCEAvelumab, Palbociclib, and Cetuximab
CetuximabERBITUXAvelumab, Palbociclib, and Cetuximab

Purpose

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.
    

Trial Arms

NameTypeDescriptionInterventions
Avelumab, Palbociclib, and CetuximabExperimentalIdentify the maximum tolerated dose (MTD) or recommended phase II dose (RP2D) for the combination of palbociclib, avelumab, and cetuximab
  • Avelumab
  • Palbociclib
  • Cetuximab

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).
      
Maximum Eligible Age:N/A
Minimum Eligible Age:18 Years
Eligible Gender:All
Healthy Volunteers:No

Primary Outcome Measures

Measure:maximum tolerated dose
Time Frame:12 months
Safety Issue:
Description:maximum tolerated dose/recommended phase II dose.

Secondary Outcome Measures

Measure:Overall response rate
Time Frame:through study completion, an average of 3 years
Safety Issue:
Description:Determined by RECIST 1.1
Measure:progression free survival
Time Frame:through study completion, an average of 3 years
Safety Issue:
Description:
Measure:overall survival
Time Frame:through study completion, an average of 3 years
Safety Issue:
Description:
Measure:Incidence of Treatment-Emergent Adverse Events [Safety and Tolerability]
Time Frame:through study completion, an average of 3 years
Safety Issue:
Description:Number of participants with treatment-related adverse events as assessed by CTCAE v4.0

Details

Phase:Phase 1
Primary Purpose:Interventional
Overall Status:Recruiting
Lead Sponsor:Kathryn Gold

Trial 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

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