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Chemotherapy Plus Cetuximab in Combination With VTX-2337 in Patients With Recurrent or Metastatic Squamous Cell Carcinoma of the Head and Neck

NCT01836029 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 195

Last updated 2019-10-29

Study results available
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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.

Conditions

  • Carcinoma, Squamous Cell of Head and Neck

Interventions

DRUG

VTX-2337

TLR8 Agonist

DRUG

Carboplatin

DRUG

Cisplatin

DRUG

5-fluorouracil

DRUG

Placebo

Sponsors & Collaborators

  • Celgene

    lead INDUSTRY

Principal Investigators

  • Ezra Cohen, MD · University of Chicago

  • Robert Ferris, MD, PhD · University of Pittsburgh

  • Amar Patel, MD · Celgene

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2013-10-14
Primary Completion
2016-04-13
Completion
2016-09-19

Countries

  • United States

Study Locations

More Related Trials

Entities

Drugs

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01836029 on ClinicalTrials.gov