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

Overview

  • Study type

    Interventional
  • Study phase

    II
  • Study IDs

  • Describes the nature of a clinical study. Types include:

    • Observational study — observes people and measures outcomes without affecting results.
    • Interventional study (clinical trial) — studies new tests, treatments, drugs, surgical procedures or devices.
    • Medical records research — uses historical information collected from medical records of large groups of people to study how diseases progress and which treatments and surgeries work best.
  • During the early phases (phases 1 and 2), researchers assess safety, side effects, optimal dosages and risks/benefits. In the later phase (phase 3), researchers study whether the treatment works better than the current standard therapy. They also compare the safety of the new treatment with that of current treatments. Phase 3 trials include large numbers of people to make sure that the result is valid. There are also less common very early (phase 0) and later (phase 4) phases. Phase 0 trials are small trials that help researchers decide if a new agent should be tested in a phase 1 trial. Phase 4 trials look at long-term safety and effectiveness, after a new treatment has been approved and is on the market.

  • Site IRB
    • Scottsdale/Phoenix, Arizona: 13-005484
    NCT ID: NCT01836029
    Sponsor Protocol Number: VRXP-A202

About this study

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.

Participation eligibility

Participant eligibility includes age, gender, type and stage of disease, and previous treatments or health concerns. Guidelines differ from study to study, and identify who can or cannot participate. If you need assistance understanding the eligibility criteria, please contact the study team.

See 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

Participating Mayo Clinic locations

Study statuses change often. Please contact us for help.

Mayo Clinic Location Status Contact

Scottsdale/Phoenix, Ariz.

Mayo Clinic principal investigator

Kelly Curtis, M.D.

Closed for enrollment

Contact information:

Research Information Center

800-664-4542

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CLS-20111791

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