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A Study of Atezolizumab (Anti−Pd-L1 Antibody) as Adjuvant Therapy After Definitive Local Therapy in Patients With High-Risk Locally Advanced Squamous Cell Carcinoma of the Head and Neck

NCT03452137

Description:

This study will evaluate the efficacy and safety of atezolizumab compared with placebo as adjuvant therapy after definitive local therapy in patients with high-risk locally advanced squamous cell carcinoma of the head and neck (SCCHN)

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

Recruiting

Phase:

Phase 3

Trial Eligibility

Document

Title

  • Brief Title: A Study of Atezolizumab (Anti−Pd-L1 Antibody) as Adjuvant Therapy After Definitive Local Therapy in Patients With High-Risk Locally Advanced Squamous Cell Carcinoma of the Head and Neck
  • Official Title: A Phase III, Multicenter, Randomized, Double-Blind, Placebo-Controlled Study of Atezolizumab (Anti−Pd-L1 Antibody) as Adjuvant Therapy After Definitive Local Therapy in Patients With High-Risk Locally Advanced Squamous Cell Carcinoma of the Head and Neck

Clinical Trial IDs

  • ORG STUDY ID: WO40242
  • SECONDARY ID: 2017-003302-40
  • NCT ID: NCT03452137

Conditions

  • Locally Advanced Squamous Cell Carcinoma of the Head and Neck (SCCHN)

Interventions

DrugSynonymsArms
AtezolizumabAtezolizumab
PlaceboPlacebo

Purpose

This study will evaluate the efficacy and safety of atezolizumab compared with placebo as adjuvant therapy after definitive local therapy in patients with high-risk locally advanced squamous cell carcinoma of the head and neck (SCCHN)

Trial Arms

NameTypeDescriptionInterventions
AtezolizumabActive ComparatorParticipants will receive Atezolizumab for 16 cycles, or up to 1 year (whichever occurs first)
  • Atezolizumab
PlaceboExperimentalParticipants will receive Placebo for 16 cycles, or up to 1 year (whichever occurs first).
  • Placebo

Eligibility Criteria

        Inclusion Criteria

          -  Histologically or cytologically confirmed Squamous Cell Carcinoma of the Head and Neck
             (SCCHN)

          -  Human Papilloma Virus (HPV) status

          -  Completed definitive local therapy

          -  Absence of metastatic disease as documented by radiographic scans

          -  Adequate hematologic and end-organ function

          -  For patients receiving therapeutic anticoagulation: stable anticoagulant regimen

          -  For women of childbearing potential: agreement to remain abstinent or use
             contraceptive methods with a failure rate of < 1% per year during the treatment period
             and for 5 months after the last dose of study treatment. Women must refrain from
             donating eggs during this same period.

          -  Confirmed response of Complete Response (CR), Partial Response (PR), or Stable Disease
             (SD) to definitive local therapy documented by CT with contrast or MRI with contract
             to head and neck region done >= 8 weeks after completion of definitive local therapy
             and within 28 days prior to initiation of study drug.

        Exclusion Criteria:

          -  Patients who have received surgery alone or radiotherapy alone as definitive local
             therapy

          -  Squamous cell carcinoma of the nasopharynx or paranasal sinuses or non-squamous
             histology

          -  Evidence of disease progression or metastatic disease during or following definitive
             local therapy documented in post-definitive local therapy screening scans

          -  Uncontrolled or symptomatic hypercalcemia

          -  Active or history of autoimmune disease or immune deficiency

          -  Active tuberculosis

          -  Significant cardiovascular disease

          -  History of malignancy, including prior SCCHN primary tumors within 5 years prior to
             screening, with the exception of malignancies with a negligible risk of metastasis or
             death

          -  Prior allogeneic stem cell or solid organ transplantation

          -  Current treatment with anti-viral therapy for Hepatitis B Virus (HBV)

          -  Treatment with systemic immunostimulatory agents

          -  Treatment with systemic immunosuppressive medication

          -  History of severe allergic anaphylactic reactions to chimeric or humanized antibodies
             or fusion proteins

          -  Pregnancy or breastfeeding, or intention of becoming pregnant during study treatment
             or within 5 months after the last dose of study treatment

          -  Patients who have received a non-FDA or non-EMA approved anti-EGFR agent or any other
             non-FDA or non-EMA, approved agent as part of definitive local therapy, unless the
             unapproved agent was given in addition to an approved agent

          -  Any systemic therapies after permitted definitive local therapies
      
Maximum Eligible Age:N/A
Minimum Eligible Age:18 Years
Eligible Gender:All
Healthy Volunteers:No

Primary Outcome Measures

Measure:Independent Review Facility assessed Event Free Survival (IRF assessed EFS)
Time Frame:Randomization to the first documented disease recurrence, or disease progression (per Response Evaluation Criteria In Solid Tumors (RECIST v1.1)), or death from any cause, whichever occurs first, through the end of study (approximately 65 months)
Safety Issue:
Description:

Secondary Outcome Measures

Measure:Investigator Assessed Event Free Survival (EFS)
Time Frame:Randomization to the first documented disease recurrence, or disease progression (per RECIST v1.1) or death from any cause, whichever occurs first, through the end of study (approximately 65 months)
Safety Issue:
Description:
Measure:Percentage of Participants with Adverse Events
Time Frame:Baseline until up to 90 days after end of treatment (approximately 65 months)
Safety Issue:
Description:
Measure:Serum Concentration of Atezolizumab
Time Frame:At pre-defined intervals from Cycle 1, Day 1, through end of treatment (approximately 1 year).
Safety Issue:
Description:
Measure:Change from baseline in physical function and Quality of Life Global Health Status/Quality of Life Scales of the European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire
Time Frame:Baseline up until 30 days from last dose (approximately 65 months overall)
Safety Issue:
Description:

Details

Phase:Phase 3
Primary Purpose:Interventional
Overall Status:Recruiting
Lead Sponsor:Hoffmann-La Roche

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