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

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.

Study Overview

• Status: Completed
• Conditions: Head and Neck Cancer
• Intervention / Treatment: Drug: MEHD7945A; Drug: cetuximab

• Study Type: Interventional
• Enrollment (Actual): 122
• Phase: Phase 2

Contacts and Locations

Study Locations

• Australia
  • New South Wales
    • Darlinghurst, New South Wales, Australia, 2010
    • Waratah, New South Wales, Australia, 2298
    • Wollongong, New South Wales, Australia, 2500
  • Queensland
    • Brisbane, Queensland, Australia, 4029
  • South Australia
    • Kurralta Park, South Australia, Australia, 5037
  • Victoria
    • Melbourne, Victoria, Australia, 3002
• Belgium
  • Edegem, Belgium, 2650
  • Namur, Belgium, 5000
• Bulgaria
  • Pleven, Bulgaria, 5800
  • Ruse, Bulgaria, 7000
  • Sofia, Bulgaria, 1303
• France
  • Clichy, France, 92118
  • Lyon, France, 69373
  • Villejuif, France, 94805
• Germany
  • Berlin, Germany, 12200
  • Essen, Germany, 45122
• Hungary
  • Debrecen, Hungary, 4032
  • Gyor, Hungary, 9024
  • Szolnok, Hungary, 5004
• Italy
  • Friuli-Venezia Giulia
    • Udine, Friuli-Venezia Giulia, Italy, 33100
  • Lombardia
    • Milano, Lombardia, Italy, 20133
    • Milano, Lombardia, Italy, 20162
  • Piemonte
    • Orbassano, Piemonte, Italy, 10043
    • Torino, Piemonte, Italy, 10126
• Romania
  • Brasov, Romania, 500019
  • Cluj-Napoca, Romania, 400058
  • Cluj-Napoca, Romania, 400015
  • Timisoara, Romania, 300239
• Spain
  • Barcelona, Spain, 08035
  • Madrid, Spain, 28041
  • Madrid, Spain, 28050
  • Salamanca, Spain, 37007
  • Valencia, Spain, 46010
• United Kingdom
  • Coventry, United Kingdom, CV2 2DX
  • Glasgow, United Kingdom, G12 0YN
  • London, United Kingdom, SW3 6JJ
  • Sutton, United Kingdom, SM2 5PT
• United States
  • California
    • Stanford, California, United States, 94305
  • Colorado
    • Aurora, Colorado, United States, 80045
  • Florida
    • Miami, Florida, United States, 33176
  • Illinois
    • Chicago, Illinois, United States, 60637
  • Kentucky
    • Paducah, Kentucky, United States, 42003
  • Maryland
    • Baltimore, Maryland, United States, 21204
  • Massachusetts
    • Boston, Massachusetts, United States, 02215
    • Boston, Massachusetts, United States, 02114
  • Missouri
    • St Joseph, Missouri, United States, 64507
  • New York
    • New York, New York, United States, 10011
  • North Carolina
    • Chapel Hill, North Carolina, United States, 27599-7295
  • South Carolina
    • Charleston, South Carolina, United States, 29425
  • Tennessee
    • Knoxville, Tennessee, United States, 37909
  • Wisconsin
    • Madison, Wisconsin, United States, 53705-2275

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: A: MEHD7945A	Drug: MEHD7945A; 1100 mg iv every 2 weeks
Active Comparator: B: Cetuximab	Drug: cetuximab; 400 mg/m2 iv loading dose, followed by 250 mg/m2 weekly

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Progression-free survival (tumor assessments according to RECIST criteria)	approximately 24 months

Secondary Outcome Measures

Outcome Measure	Time Frame
Safety: Incidence of adverse events	approximately 24 months
Objective response: complete response or partial response	approximately 24 months
Disease control: complete response, partial response or stable disease	approximately 24 months
Duration of objective response	approximately 24 months
Time to disease progression	approximately 24 months
Overall survival	approximately 24 months
Pharmacokinetics: Cmax/Cmin	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	Pre-dose on Day 1 of Cycles 1 and 4, and at treatment completion

Collaborators and Investigators

• Sponsor: Genentech, Inc.

Study record dates

Study Major Dates

• Study Start: July 1, 2012
• Primary Completion (Actual): June 1, 2015
• Study Completion (Actual): June 1, 2015

Study Registration Dates

• First Submitted: April 11, 2012
• First Submitted That Met QC Criteria: April 11, 2012
• First Posted (Estimate): April 13, 2012

Study Record Updates

• Last Update Posted (Estimate): November 2, 2016
• Last Update Submitted That Met QC Criteria: November 1, 2016
• Last Verified: November 1, 2016

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Neoplasms by Histologic Type; Neoplasms; Neoplasms by Site; Carcinoma; Neoplasms, Glandular and Epithelial; Head and Neck Neoplasms; Neoplasms, Squamous Cell; Carcinoma, Squamous Cell; Squamous Cell Carcinoma of Head and Neck; Antineoplastic Agents; Antineoplastic Agents, Immunological; Cetuximab
• Other Study ID Numbers: GO28076; 2011-005539-22 (EudraCT Number)