A Phase 1 interventional study of RO5083945 and cetuximab in Head and Neck Cancer, sponsored by Hoffmann-La Roche. Completed at 7 sites in 5 countries. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2016-09-14.
Sponsored by Hoffmann-La Roche · Phase 1, Interventional, and Treatment
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.
1,772 studies on the registry are indexed under Carcinoma, Squamous Cell; 412 are open to participants now.
This study's enrollment of 62 is above the median of 44 across 1,414 interventional studies indexed under Carcinoma, Squamous Cell.
Browse Carcinoma, Squamous Cell studies →Hoffmann-La Roche is the lead sponsor of 2,061 studies on the registry; 85 are open to participants now.
Of its 319 completed or terminated interventional studies of FDA-regulated products, 239 (75%) have results posted.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
Drug: RO5083945
Drug: cetuximab
700mg iv weekly
400mg/m2 iv 1st dose, 250mg/m2 iv subsequent weekly doses
immune cell infiltration head and neck squamous cell cancer (HNSCC)
Time frame: through study completion or early study discontinuation
pharmacodynamics: T lymphocytes, B lymphocytes, NK cells, plasma cytokine levels
Time frame: through study completion or early study discontinuation
safety and efficacy: AEs, laboratory parameters, tumour assessments
Time frame: through study completion or early study discontinuation
This study is completed, as verified in Sep 2016. You cannot join it, but the record below documents what was studied.
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Hoffmann-La Roche