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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
122
1100 mg iv every 2 weeks
400 mg/m2 iv loading dose, followed by 250 mg/m2 weekly
Unnamed facility
Stanford, California, United States
Unnamed facility
Aurora, Colorado, United States
Unnamed facility
Miami, Florida, United States
Unnamed facility
Chicago, Illinois, United States
Unnamed facility
Paducah, Kentucky, United States
Unnamed facility
Progression-free survival (tumor assessments according to RECIST criteria)
Time frame: approximately 24 months
Objective response: complete response or partial response
Time frame: approximately 24 months
Disease control: complete response, partial response or stable disease
Time frame: approximately 24 months
Duration of objective response
Time frame: approximately 24 months
Time to disease progression
Time frame: approximately 24 months
Overall survival
Time frame: approximately 24 months
Safety: Incidence of adverse events
Time frame: approximately 24 months
Pharmacokinetics: Cmax/Cmin
Time frame: Pre-dose and 30 min after end of infusion on Day 1 of Cycles 1, 2, 3, and 4, and at treatment completion
Immunogenicity: anti-MEHD7945A levels
Time frame: Pre-dose on Day 1 of Cycles 1 and 4, and at treatment completion
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.
Baltimore, Maryland, United States
Unnamed facility
Boston, Massachusetts, United States
Unnamed facility
Boston, Massachusetts, United States
Unnamed facility
Saint Joseph, Missouri, United States
Unnamed facility
New York, New York, United States
...and 41 more locations