A Phase II, Open-Label, Randomized Study of MEDH7945A Versus Cetuximab in Patients With Recurrent/Metastatic Squamous Cell Carcinoma of the Head and Neck Who Have Progressed During or Following Platinum-based Chemotherapy

This phase II, open-label, randomized study will evaluate the efficacy and safet y of MEHD7945A versus cetuximab in patients with recurrent/metastatic squamous c ell carcinoma of the head and neck who have progressed during or following plati num-based chemotherapy. Patients will be randomized to receive either MEHD7945A 1100 mg intravenously (iv) every 2 weeks or cetuximab 400 mg/m2 iv loading dose followed by 250 mg/m2 iv weekly. Patients treated with cetuximab (Arm B) may cro ss-over to MEHD7945A (Arm A) upon central confirmation of progressive disease an d upon meeting eligibility criteria. Anticipated time on study treatment is unti l disease progression or intolerable toxicity occurs.

Stanford is not currently accepting new patients for this trial. You may want to check clinicaltrials.gov to see if other locations are recruiting.

Investigator(s):

Intervention(s):

  • drug : cetuximab
  • drug : MEHD7945A

Phase: Phase 2

Eligibility

Ages Eligible For Study:

18 Years - N/A

Inclusion Criteria

- Adult patients, >/= 18 years of age - Histologically confirmed Stage III or IV recurrent/metastatic squamous cell carcinoma of the head and neck (R/M SCCHN) - Progressive disease on or after first-line platinum-based chemotherapy regimen for R/M SCCHN (maximum of 6 cycles) - No more than one platinum-based chemotherapy regimen for R/M SCCHN is allowed - Prior platinum-based treatment as definitive chemo/radiotherapy for locally advanced disease is allowed if completed/terminated >/= 6 months before the platinum-based regimen for R/M SCCHN - Consent to provide archival tumor tissue for biomarker testing - Measurable disease per RECIST v1.1 - ECOG performance status of 0, 1 or 2 - Adequate hematologic, renal and liver function

External Links

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Contact information

Primary Contact:

Ruth Lira 6507231367

Stanford University School of Medicine 300 Pasteur Drive Stanford, CA 94305

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