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

• Register: ClinicalTrials.gov
• Last refreshed on: 6 May 2024
• Main ID: NCT03452137
• Date of registration: 25/02/2018
• Prospective Registration: Yes
• Primary sponsor: Hoffmann-La Roche
• Public 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
• Scientific 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
• Date of first enrolment: April 3, 2018
• Target sample size: 406
• Recruitment status: Terminated
• URL: https://clinicaltrials.gov/ct2/show/NCT03452137
• Study type: Interventional
• Study design: Allocation: Randomized. Intervention model: Parallel Assignment. Primary purpose: Treatment. Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor).
• Phase: Phase 3

Countries of recruitment

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

Contacts

• Name: Clinical Trials
• Affiliation: Hoffmann-La Roche

Key inclusion & exclusion 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



Age minimum: 18 Years
Age maximum: N/A
Gender: All

Health Condition(s) or Problem(s) studied

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

Intervention(s)

Drug: Placebo

Drug: Atezolizumab

Primary Outcome(s)

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 65 months)]

Secondary Outcome(s)

Serum Concentration of Atezolizumab [Time Frame: At pre-defined intervals from Cycle 1, Day 1, through end of treatment (approximately 1 year).]

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 65 months)]

Incidence of ADA Response to Atezolizumab [Time Frame: At pre-defined intervals from Cycle 1, Day 1, through end of treatment (approximately 1 year).]

Percentage of Participants with Adverse Events [Time Frame: Baseline until up to 90 days after end of treatment (approximately 99 months)]

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 to 3 Months and 6 Months]

Overall Survival (OS) after Randomization [Time Frame: Randomization to death from any cause, through the end of study (approximately 99 months)]

Secondary ID(s)

WO40242

2017-003302-40

Source(s) of Monetary Support

Please refer to primary and secondary sponsors