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 safety of MEHD7945A versus cetuximab in patients with recurrent/metastatic squamous cell carcinoma of the head and neck who have progressed during or following platinum-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 cross-over to MEHD7945A (Arm A) upon central confirmation of progressive disease and upon meeting eligibility criteria. Anticipated time on study treatment is until 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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