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

• Status: Completed
• Trial end date: 2016-09-19
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Celgene; VentiRx Pharmaceuticals Inc.
• Treatments: Carboplatin; Cetuximab; Cisplatin; Fluorouracil

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 that has not previously been treated with systemic therapy of 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 localized SCCHN and completed at least 6 months prior to disease recurrence

• 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

• History of another primary malignancy, with the exception of (i) curatively resected non-melanoma skin cancer, (ii) curatively treated in situ cervical cancer, or (iii) other malignancy curatively treated with no evidence of disease and no anticancer therapy administered for 3 years prior to randomization, with the exception of adjuvant hormonal therapy for breast cancer

• Other conditions or circumstances that could interfere with the study