A Phase Ib/II, Multicenter Study of LJM716 in Combination With Cetuximab in Patients With Platinum-pretreated Recurrent/Metastatic Head and Neck Squamous Cell Carcinoma

Location:

Phoenix/Scottsdale, Ariz.

Trial status:

Open for Enrollment

Why is this study being done?

To establish whether LJM716 in combination with cetuximab is safe and has beneficial effects in patients with platinum-pretreated recurrent/metastatic head and neck squamous cell carcinoma.

Who is eligible to participate?

Inclusion Criteria: - Most recent regimen contains both platinum and cetuximab (Phase II, group B). - ECOG Performance Status (PS) ≤ 2. - Recovery from all AEs of previous anti-cancer therapies, to baseline or to CTCAE Grade ≤ 1, except for alopecia. - Measurable disease as determined by RECIST v1.1. Exclusion Criteria: - Previous anti-HER3 antibody treatment. - Symptomatic brain metastasis. - Prior systemic anti-cancer treatment, within a period of time that is shorter than the cycle length used for that treatment prior to starting study treatment. - Prior anaphylactic or other severe infusion reaction to human immunoglobulin or antibody formulations. - Inadequate end organ function. - Ongoing diarrhea CTCAE Grade ≥ 2. Other protocol-defined inclusion/exclusion criteria may apply

Last updated:

6/26/2014

NCT ID:

NCT02143622

IRB Number:

14-002139