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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

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ClinicalTrials.gov Identifier: NCT03452137
Recruitment Status : Recruiting
First Posted : March 2, 2018
Last Update Posted : June 24, 2020
Sponsor:
Information provided by (Responsible Party):
Hoffmann-La Roche

Tracking Information
First Submitted Date  ICMJE February 25, 2018
First Posted Date  ICMJE March 2, 2018
Last Update Posted Date June 24, 2020
Actual Study Start Date  ICMJE April 3, 2018
Estimated Primary Completion Date March 22, 2021   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: January 18, 2019)
  • 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) ]
  • Overall Survival (OS) after Randomization [ Time Frame: Randomization to death from any cause, through the end of study (approximately 65 months) ]
Original Primary Outcome Measures  ICMJE
 (submitted: February 28, 2018)
  • 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 64 months) ]
  • Overall Survival (OS) after Randomization [ Time Frame: Randomization to death from any cause, through the end of study (approximately 64 months) ]
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: January 18, 2019)
  • 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) ]
  • Percentage of Participants with Adverse Events [ Time Frame: Baseline until up to 90 days after end of treatment (approximately 65 months) ]
  • Serum Concentration of Atezolizumab [ Time Frame: At pre-defined intervals from Cycle 1, Day 1, through end of treatment (approximately 1 year). ]
  • 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) ]
Original Secondary Outcome Measures  ICMJE
 (submitted: February 28, 2018)
  • 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 64 months) ]
  • Percentage of Participants with Adverse Events [ Time Frame: Baseline until up to 90 days after end of treatment (approximately 64 months ]
  • Serum Concentration of Atezolizumab [ Time Frame: At pre-defined intervals from Cycle 1, Day 1, through end of treatment (approximately 1 year). ]
  • 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 64 months overall) ]
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE 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  ICMJE 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
Brief Summary 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)
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 3
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Condition  ICMJE Locally Advanced Squamous Cell Carcinoma of the Head and Neck (SCCHN)
Intervention  ICMJE
  • Drug: Atezolizumab
    Atezolizumab intravenous infusion will be administered at a fixed dose on Day 1 of each 21-day cycle for 16 cycles.
  • Drug: Placebo
    Placebo intravenous infusion will be administered a fixed dose on Day 1 of each 21-day cycle for 16 cycles.
Study Arms  ICMJE
  • Active Comparator: Atezolizumab
    Participants will receive Atezolizumab for 16 cycles, or up to 1 year (whichever occurs first)
    Intervention: Drug: Atezolizumab
  • Experimental: Placebo
    Participants will receive Placebo for 16 cycles, or up to 1 year (whichever occurs first).
    Intervention: Drug: Placebo
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: February 28, 2018)
400
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE June 17, 2022
Estimated Primary Completion Date March 22, 2021   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
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: Reference Study ID Number: WO40242 www.roche.com/about_roche/roche_worldwide.htm 888-662-6728 (U.S. and Canada) global-roche-genentech-trials@gene.com
Listed Location Countries  ICMJE Australia,   Belgium,   Brazil,   Canada,   China,   France,   Germany,   Hungary,   India,   Italy,   Japan,   Korea, Republic of,   Poland,   Portugal,   Russian Federation,   South Africa,   Spain,   Taiwan,   Thailand,   Turkey,   Ukraine,   United Kingdom,   United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT03452137
Other Study ID Numbers  ICMJE WO40242
2017-003302-40 ( EudraCT Number )
Has Data Monitoring Committee Not Provided
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 Not Provided
Responsible Party Hoffmann-La Roche
Study Sponsor  ICMJE Hoffmann-La Roche
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Director: Clinical Trials Hoffmann-La Roche
PRS Account Hoffmann-La Roche
Verification Date June 2020

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