Head and Neck Cancer
Conditions
Brief summary
This open-label study will assess the pharmacodynamics, safety and efficacy of RO5083945 as compared to cetuximab in patients with head and neck squamous cell carcinoma. Patients will receive at least 2 infusions of either RO5083945 or cetuximab. Anticipated time on study treatment is up to 3 months, and target sample size is \<50.
Interventions
DRUGRO5083945
700mg iv weekly
DRUGcetuximab
400mg/m2 iv 1st dose, 250mg/m2 iv subsequent weekly doses
Sponsors
Hoffmann-La Roche
Study design
Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* adult patients, \>/=18 years of age * squamous cell carcinoma of the oral cavity, oropharynx, hypopharynx or larynx
Exclusion criteria
* carcinoma of nasal cavity, paranasal sinus and nasopharynx * recurrent squamous cell carcinoma of the oral cavity, oropharynx, hypopharynx or larynx * known positivity for HIV, hepatitis B and/or hepatitis C infection
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| immune cell infiltration head and neck squamous cell cancer (HNSCC) | through study completion or early study discontinuation |
Secondary
| Measure | Time frame |
|---|---|
| pharmacodynamics: T lymphocytes, B lymphocytes, NK cells, plasma cytokine levels | through study completion or early study discontinuation |
| safety and efficacy: AEs, laboratory parameters, tumour assessments | through study completion or early study discontinuation |
Countries
France, Italy, Netherlands, Spain, United Kingdom
Outcome results
None listed