An exploratory, open label, multicenter study to investigate pharmacodynamic of RO5083945, a human monoclonal antibody antagonist of Epidermal Growth Factor Receptor (EGFR), compared to cetuximab in patients with operable head and neck squamous cell carcinoma.

Withdrawn

• Conditions: hoofd hals carcinoom; operable head and neck squamous cell carcinoma; 10027656

• Registration Number: NL-OMON34195
• Lead Sponsor: Roche Nederland B.V.

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Last Update Posted: 6 May 2024

Recruitment & Eligibility

• Status: Withdrawn
• Sex: Not specified
• Target Recruitment: 6

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

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

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
<p>- Immune cell infiltration<br /><br>- Immune cell activation</p><br>

Secondary Outcome Measures

Name	Time	Method
<p>- Maturation of human T-cell lymphocytes<br /><br>- NK cell lytic activity and activation<br /><br>- Human T-regulatory test<br /><br>- Determine gene expression profiles<br /><br>- Determine new circulating factors/potential pharmacodynamic biomarkers, like<br /><br>circulating tumor cells or mutant DNA<br /><br>- Correlation bewteen antibody polymorfisms and PD parameters<br /><br>- Anti-cancer activity by PET/CT<br /><br>- Comparison of cetuximab and RO5083945 responses<br /><br>- Correlation between PK and PD, effucay and safety<br /><br>- Safetyprofile of RO5083945</p><br>