West Cancer Center

HEAD AND NECK: Metastatic; 1st line; "VRXP-A202"

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

Title

VentiRx VRXP-A202

Study Title

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

Site Link

NCT01836029

Malignancy

Head and Neck Cancer: Oropharyngeal (Oropharynx), Oral Cavity, Laryngeal (Larynx), Hypopharyngeal (Hypopharynx)

Stage

Stage 4

Disease Setting

Metastatic/Palliative

Line Of Therapy

1st

Investigational Agent

VTX-2337

Drug Class

Toll-like receptor (TLR) 8 agonist, activation of NK cells

Moon Fenton, MD, PhD

Sponsor

VentiRx Pharmaceuticals

Phase

Phase 2

Status

Closed to Accrual

Key Eligibility Criteria

http://www.clinicaltrials.gov/ct2/show/NCT01836029?term=VRXP-A202&rank=1

Key Eligibility Criteria Details

Squamous cell carcinoma of head and neck No nasopharyngeal salivary, lip, or sinonasal primary Unresectable locoregionally recurrent or metastatic disease No prior metastatic systemic therapy ECOG 0-1 No active brain mets No active autoimmune disease or immunosuppressants No significant cardiac disease within 6 months

Objective

Primary- PFS: Secondary- OS, ORR, DOBR, DCR, DDC, Safety, PK

Assessment Frequency

Assessment Frequency 2

Assessment Frequency Link

Path

Squamous cell carcinoma

Dosing Frequency

VTX-2337 3.0mg/m2 Day 8, 15 of 21 day cycle x6 cycles

Control Agents

Cisplatin or Carboplatin, 5-FU, Cetuximab

Study Protocol

Randomized

Yes