Chemotherapy Plus Cetuximab in Combination With VTX-2337 in Patients With Recurrent or Metastatic Squamous Cell Carcinoma of the Head and Neck
Condition: Carcinoma, Squamous Cell of Head and Neck
MeSH terms: Carcinoma; Carcinoma, Squamous Cell; Squamous Cell Carcinoma of Head and Neck
Intervention: VTX-2337; Carboplatin; Cisplatin; 5-fluorouracil; Placebo
Intervention description: TLR8 Agonist
Intervention MeSH terms: Carboplatin; Fluorouracil
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 195.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: SCCHN; HNSCC

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.
    

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 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