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

Status: Recruiting
Phase: Phase 2
Diagnosis: Head and Neck Cancer
NCT ID: NCT01836029 (View complete trial on ClinicalTrials.gov)
DFCI Protocol ID:

 

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.

 

Conducting Institutions:
Brigham and Women's Hospital, Dana-Farber Cancer Institute

Overall PI:
Robert Haddad, MD, Dana-Farber Cancer Institute

Site-responsible Investigators:

Contacts:
Dana-Farber Cancer Institute: Rosemary Costello, rcostello@partners.org

Eligibility Criteria

Inclusion Criteria: - Ability and willingness to provide written informed consent - Histologically or cytologically confirmed squamous cell carcinoma of the head and neck - Locoregionally recurrent or metastatic disease - At least one measurable lesion on screening CT or MRI - 18 years of age or older - ECOG performance status of 0 or 1 - Acceptable bone marrow, renal, and hepatic function based upon screening lab tests - Willingness to use medically acceptable contraception - For females with reproductive potential: a negative serum pregnancy test Exclusion Criteria: - Disease which is amenable to curative local therapy - Nasopharyngeal, salivary gland, lip or sinonasal carcinoma - Surgery or irradiation ≤ 4 weeks prior to randomization - Prior systemic anti-cancer therapy, unless administered for locally advanced disease and completed ≥ 6 months prior to randomization - Treatment with an investigational agent ≤ 30 days prior to randomization - Treatment with corticosteroids within 2 weeks - A requirement for chronic systemic immunosuppressive therapy for any reason - Prior serious infusion reaction to cetuximab - Treatment with an immunotherapy within 30 days - Known brain metastases, unless stable for at least 28 days - Active autoimmune disease currently requiring therapy - Known infection with HIV - Significant cardiac disease within 6 months - Pregnant or breast-feeding females - Other conditions or circumstances that could interfere with the study
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