A clinical trial to compare atezolizumab with a placebo in people with head and neck cancer who are at a high risk of their cancer returning or getting worse after completion of standard initial therapy.

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

Cancer
Head and Neck Cancer
Squamous Cell Carcinoma of the Head and Neck (SCCHN)

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Basic Details

Sponsor Hoffmann-La Roche

Phase Phase 3

Trial Identifier NCT03452137, WO40242, 2017-003302-40

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

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

Study 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)

Eligibility Criteria

Gender

All

Age

≥ 18 Years

Healthy Volunteers

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

The source of the below information is public registry websites such as ClinicalTrials.gov, EuClinicalTrials.eu, ISRCTN.com, etc.. It has been summarised and edited into simpler language. For more information about this clinical study see the For Expert tab on the specific ForPatients page or follow these links to https://clinicaltrials.gov and/or https://euclinicaltrials.eu and/or https://www.isrctn.com.

The information is taken directly from public registry websites such as ClinicalTrials.gov, EuClinicalTrials.eu, ISRCTN.com, etc., and has not been edited.

Results Disclaimer

What is Clinical Research?

In clinical research, volunteers, researchers, and medical professionals work together toward a shared goal: better treatment outcomes for patients. Clinical trials are vital to their process. They are carefully designed and follow approved protocols.

A clinical trial to compare atezolizumab with a placebo in people with head and neck cancer who are at a high risk of their cancer returning or getting worse after completion of standard initial therapy.

Basic Details

Study Summary

Eligibility Criteria

What is Clinical Research?

For the latest version of this information please go to www.forpatients.roche.com

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A clinical trial to compare atezolizumab with a placebo in people with head and neck cancer who are at a high risk of their cancer returning or getting worse after completion of standard initial therapy.

For the latest version of this information please go to www.forpatients.roche.com