Clinical trial · Interventional
A Study of Pharmacodynamics of RO5083945 in Patients With Head and Neck Squamous Cell Carcinoma
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
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Head and Neck Cancer | Malignant Head and Neck Neoplasm | ALIAS | 0.90 |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| cetuximab | Drug | Cetuximab | ALIAS |
| RO5083945 | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- A
- interventionNames
- Drug: RO5083945
- type
- ACTIVE_COMPARATOR
- label
- B
- interventionNames
- Drug: cetuximab
Primary outcomes (1)
- measure
- immune cell infiltration head and neck squamous cell cancer (HNSCC)
- timeFrame
- through study completion or early study discontinuation
Secondary outcomes (2)
- measure
- pharmacodynamics: T lymphocytes, B lymphocytes, NK cells, plasma cytokine levels
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
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
References
Publications (1)
- DERIVEDTemam S, Spicer J, Farzaneh F, Soria JC, Oppenheim D, McGurk M, Hollebecque A, Sarini J, Hussain K, Soehrman Brossard S, Manenti L, Evers S, Delmar P, Di Scala L, Mancao C, Feuerhake F, Andries L, Ott MG, Passioukov A, Delord JP. An exploratory, open-label, randomized, multicenter study to investigate the pharmacodynamics of a glycoengineered antibody (imgatuzumab) and cetuximab in patients with operable head and neck squamous cell carcinoma. Ann Oncol. 2017 Nov 1;28(11):2827-2835. doi: 10.1093/annonc/mdx489. PMID 28950289