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)
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
Drug | Synonyms | Arms |
---|
Atezolizumab | | Atezolizumab |
Placebo | | Placebo |
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
Name | Type | Description | Interventions |
---|
Atezolizumab | Active Comparator | Participants will receive Atezolizumab for 16 cycles, or up to 1 year (whichever occurs first) | |
Placebo | Experimental | Participants will receive Placebo for 16 cycles, or up to 1 year (whichever occurs first). | |
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: | Investigator-assessed Event Free Survival (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 54 months) |
Safety Issue: | |
Description: | |
Secondary 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 RECIST v1.1) or death from any cause, whichever occurs first, through the end of study (approximately 54 months) |
Safety Issue: | |
Description: | |
Measure: | Percentage of Participants with Adverse Events |
Time Frame: | Baseline until up to 90 days after end of treatment (approximately 54 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 54 months overall) |
Safety Issue: | |
Description: | |
Details
Phase: | Phase 3 |
Primary Purpose: | Interventional |
Overall Status: | Recruiting |
Lead Sponsor: | Hoffmann-La Roche |
Last Updated
August 5, 2021