A Study of MEHD7945A Versus Cetuximab in Patients With Recurrent/Metastatic Squamous Cell Carcinoma of The Head And Neck

• Status: Completed
• Trial end date: 2015-06-01
• Target enrollment: 0
• Participant gender: All

Summary

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.

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

Details

• Lead Sponsor: Genentech, Inc.
• Treatments: Cetuximab; Immunoglobulin G

Criteria

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

Exclusion Criteria:

• Nasopharyngeal cancer

• Prior treatment with an investigational or approved agent for the purpose of inhibiting HER family members

• This includes but is not limited to cetuximab, panitumumab, erlotinib, geftinib, and lapatinib

• Prior treatment with an EGFR inhibitor is allowed if it was administered as part of definitive therapy for locally advanced disease and completed >/=1 year before study enrollment

• Leptomeningeal disease as the only manifestation of the current malignancy

• Active infection requiring iv antibiotics

• Active autoimmune disease that is not controlled by non-steroidal anti-inflammatory drugs

• Current severe, uncontrolled systemic disease (e.g. clinically significant cardiovascular, pulmonary, or metabolic disease; wound healing disorders; ulcers; bone fractures)

• History of heart failure or serious cardiac arrhythmia

• History of myocardial infarction within 6 months of Cycle 1, Day 1

• Clinically significant liver disease, including active viral, alcoholic or other hepatitis, cirrhosis, or current alcohol abuse

• HIV infection

• Primary central nervous system (CNS) malignancy or untreated/active CNS metastases (progressing or requiring anticonvulsants or corticosteroids for symptomatic control)

• Pregnant or lactating women

• Malignancies other than SCCHN within 5 years prior to randomization, with the exception of adequately treated basal or squamous cell skin cancer and carcinoma in situ of the cervix