hoofd hals carcinoom operable head and neck squamous cell carcinoma
Conditions
Interventions
One of the two arms receives cetuximab (400 mg/m² [1e infuus] / 250 mg/m² [2e
en volgend infuus]) each week, with a maximum of 3 infusions. The other arm
receives RO5083945 (1400 mg) each week, with
Sponsors
Roche Nederland B.V.
Eligibility
Age
18 Years to 99 Years
Inclusion criteria
Inclusion criteria: 1. Signed Informed consent 2. Age >=18 years 3. Able and willing to comply with the protocol 4. Histologically confirmed squamous cell carcinoma 5. naive for chemaotherapy and radiotherapy 6. Tumor T2-4, any N, M0 disease. Tumore must be considered resectable in a curative intent with a planned surgical excision 7. Last administration of a corticosteriod or an antihistamine >= 14 days prior to RO5083945/cetuximab infusion
Exclusion criteria
Exclusion criteria: 1. Carcinoma of nasal cavity, paranasal sinus and nasopharynx 2. Recurrent squamous cell carcinoma of the oral cavity, oropharynx, hypopharynx or larynx 3. Concurrent therapy with any other investigational product 4. Pregnant or lactating women 5. Hypersensitivity to the active substance or to any of the excipients 6. Uncontrolled diabetes 7. Poorly controlled hypertension 8. Patients with serious uncontrolled intercurrect illness including poorly controlled diabetes mellitus, active or uncontrolled infection 9. Known positivity for HIV, hepatitis B and /or hepatitis C infections 10. Any other disease that contraindicates the us eof an investigational drug or that may affect the interpretation of the results or render the patient at high risk from treatment complications 11. Patients with dementia or altered mental status 12. Major surgery >= 4 weeks prior to study day 1
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| - Immune cell infiltration - Immune cell activation | — |
Secondary
| Measure | Time frame |
|---|---|
| - Maturation of human T-cell lymphocytes - NK cell lytic activity and activation - Human T-regulatory test - Determine gene expression profiles - Determine new circulating factors/potential pharmacodynamic biomarkers, like circulating tumor cells or mutant DNA - Correlation bewteen antibody polymorfisms and PD parameters - Anti-cancer activity by PET/CT - Comparison of cetuximab and RO5083945 responses - Correlation between PK and PD, effucay and safety - Safetyprofile of RO5083945 | — |
Countries
Netherlands
Outcome results
None listed