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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 : September 11, 2018
Sponsor:
Information provided by (Responsible Party):
Hoffmann-La Roche

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)

Condition or disease Intervention/treatment Phase
Locally Advanced Squamous Cell Carcinoma of the Head and Neck (SCCHN) Drug: Atezolizumab Drug: Placebo Phase 3

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 400 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
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
Actual Study Start Date : April 3, 2018
Estimated Primary Completion Date : August 28, 2023
Estimated Study Completion Date : April 28, 2025

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Active Comparator: Atezolizumab
Participants will receive Atezolizumab for 16 cycles, or up to 1 year (whichever occurs first)
Drug: Atezolizumab
Atezolizumab intravenous infusion will be administered at a fixed dose on Day 1 of each 21-day cycle for 16 cycles.

Experimental: Placebo
Participants will receive Placebo for 16 cycles, or up to 1 year (whichever occurs first).
Drug: Placebo
Placebo intravenous infusion will be administered a fixed dose on Day 1 of each 21-day cycle for 16 cycles.




Primary Outcome Measures :
  1. 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) ]
  2. Overall Survival (OS) after Randomization [ Time Frame: Randomization to death from any cause, through the end of study (approximately 64 months) ]

Secondary Outcome Measures :
  1. 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) ]
  2. Percentage of Participants with Adverse Events [ Time Frame: Baseline until up to 90 days after end of treatment (approximately 64 months ]
  3. Serum Concentration of Atezolizumab [ Time Frame: At pre-defined intervals from Cycle 1, Day 1, through end of treatment (approximately 1 year). ]
  4. 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) ]


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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 confirmed Squamous Cell Carcinoma of the Head and Neck (SCCHN)
  • Human Papilloma Virus (HPV) status
  • Completed definitive local therapy and have scans, 10−12 weeks after completion of definitive local therapy confirming either Complete Response (CR), Partial Response (PR), or Stable Disease (SD). If salvage neck dissection or salvage laryngectomy is not performed, patients must initiate study treatment within 4 weeks of the screening scans and within 16 weeks after completion of the definitive local therapy. If salvage neck dissection or salvage laryngectomy is performed, patients must initiate study treatment within 4 weeks of screening scans and within 20 weeks after completion of 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

Exclusion Criteria:

  • Patients who have received surgery alone or radiotherapy alone as definitive local therapy
  • Squamous cell carcinoma of the nasopharynx
  • Evidence of disease progression or metastatic disease during or following definitive local therapy documented in the 10- to 12-week post-definitive local therapy 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 concurrent radiotherapy

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): NCT03452137


Contacts
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

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Sponsors and Collaborators
Hoffmann-La Roche
Investigators
Study Director: Clinical Trials Hoffmann-La Roche

Responsible Party: Hoffmann-La Roche
ClinicalTrials.gov Identifier: NCT03452137     History of Changes
Other Study ID Numbers: WO40242
2017-003302-40 ( EudraCT Number )
First Posted: March 2, 2018    Key Record Dates
Last Update Posted: September 11, 2018
Last Verified: September 2018

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

Additional relevant MeSH terms:
Carcinoma
Carcinoma, Squamous Cell
Head and Neck Neoplasms
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Neoplasms
Neoplasms, Squamous Cell
Neoplasms by Site
Antibodies
Antibodies, Monoclonal
Atezolizumab
Immunologic Factors
Physiological Effects of Drugs
Antineoplastic Agents