InHANSE Institute of Head and Neck Studies and Education Contact Us

 

Name:   ImVOKE010

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

 

Acronym: ImVOKE

Summary & Eligibility:

The purpose of this study is to compare the effects, good or bad, of atezolizumab versus placebo (an inactive substance that looks like atezolizumab) on patients with locally advanced cancer of the head and neck who are at high risk for disease recurrence or progression following definitive local therapy (DLT).

Atezolizumab is considered an experimental drug, which means that the health authorities have not approved it for the treatment of head and neck cancer. However, it is approved as treatment for cancers in other areas of the body.

Patients will be randomly assigned to a treatment group of either atezolizumab or placebo; this is decided by chance via a computer generated program. There is a 1 in 2 chance of being in each treatment group. Neither the patient or study doctor will know what treatment group has been assigned unless necessary for a medical emergency.

 

General Inclusion Criteria

Age ≥ 18 years at the time of signing the Informed Consent Form

Adequate blood values

Histologically or cytologically confirmed Squamous Cell Carcinoma of the Head and Neck involving the oral cavity, oropharynx, larynx, or hypopharynx

Tumour staging within protocol parameters

Completed DLT and have scans (MRI or CT) 10−12 weeks after completion, confirming either Complete Response, Partial Response, or Stable Disease  

Absence of metastatic disease as documented by radiographic scans

Availability of a representative pre-treatment tumour specimen for exploratory biomarker research  

 

General Exclusion Criteria

  • Patients who have received surgery alone as DLT
  • Tumour staging outside of protocol parameters
  • Squamous cell carcinoma of the nasopharynx
  • Evidence of disease progression or metastatic disease during or following DLT documented in the 10 - 12 week post-definitive local therapy scans
  • History of malignancy other than SCCHN within 5 years prior to screening, with the exception of malignancies with a negligible risk of metastasis or death
  • Any other disease, metabolic dysfunction, physical examination finding, or clinical laboratory finding that contraindicates the use of an investigational drug
  • Active or history of autoimmune disease or immune deficiency
  • Active tuberculosis
  • Significant cardiovascular disease
  • Pregnancy or breastfeeding, or intention of becoming pregnant during study treatment. Women of childbearing potential must  agree to remain abstinent or use sufficient contraceptive methods during the treatment period and for 5 months after the last dose of study treatment

For full inclusion and exclusion criteria please contact the InHANSE team.

Status: Pending

Sponsor: F. Hoffmann-La Roche Ltd

Study Coordinator:

Ellie Haggis
Country Study Manager (CSM)
Country Clinical Operations - UK
Roche Products Limited
6 Falcon Way, Shire Park
Welwyn Garden City, AL7 1TW, United Kingdom

[email protected]

Study Schema:

 

ImVOKE Schema

Charity appeal

Find out more about our £1m Charity appeal for the AcceleraTED cancer Treatment programme.