At a glance
ClinicalIndex Comparison RecordPhase 2Completed· 195 enrolled
Drug / intervention
VTX-2337 +4 moredrug
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.
Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
A Randomized, Double-Blind, Placebo-Controlled Study of Chemotherapy Plus Cetuximab in Combination With VTX 2337 in Patients With Recurrent or Metastatic Squamous Cell Carcinoma of the Head and Neck
In Brief
A Phase 2 clinical trial evaluating VTX-2337, Carboplatin, and 3 other interventions for Carcinoma, Squamous Cell of Head and Neck. Completed, enrolled 195 participants across 53 sites.
Detailed Summary
The purpose of this study is to compare the progression-free survival of patients with recurrent or metastatic squamous cell carcinoma of the head and neck (SCCHN) treated with VTX-2337 + cisplatin or carboplatin + 5-FU + cetuximab versus patients treated with cisplatin or carboplatin + 5-FU + cetuximab alone (standard-of-care; SOC). Safety and overall survival will also be evaluated.
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
CountriesUnited States
Collaborators--
Timeline
Phase 2CompletedFinished
20132014201520162017201820192020202120222023202420252026
First PostedApr 2013
Enrollment StartOct 2013
Primary CompletionApr 2016
Study CompletionSep 2016
TodayJul 2026
First PostedApr 19, 2013
Enrollment StartOct 14, 2013
Primary CompletionApr 13, 2016
Study CompletionSep 19, 2016
TodayJul 2, 2026
Enrollment to primary: 2.5 yearsPosted 13.2 years ago
Interventions
VTX-2337drug
TLR8 Agonist
Carboplatindrug
Cisplatindrug
5-fluorouracildrug
Placebodrug