A study to investigate whether LJM716 in combination with cetuximab is safe and has beneficial effects in patients with advanced head and neck cancer who progressed on prior therapy

Conditions: Head and neck squamous cell carcinoma
MedDRA version: 17.0Level: PTClassification code 10060121Term: Squamous cell carcinoma of head and neckSystem Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Therapeutic area: Diseases [C] - Cancer [C04]

Registration Number: EUCTR2013-005540-28-IT

Lead Sponsor: OVARTIS FARMA

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: ot Recruiting

Sex: All

Target Recruitment: 128

Inclusion Criteria

? Maximum of 1 prior therapy for recurrent or metastatic disease (Phase II)
? 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.
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 64
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 64

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.

Study & Design

Study Type: Interventional clinical trial of medicinal product

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Main Objective: Phase Ib: To determine RP2D and estimate MTD of LJM716 in combination with cetuximab in patients with RM HNSCC <br>Phase II: To access the anti-tumor activity of LJM716-cetuximab combination in cetuximab naïve (Group A) and cetuximab pretreated (Group B) patients with RM HNSCC;Secondary Objective: To further characterize the safety and tolerability of the combination<br>To characterize the PK profiles of LJM716 and describe cetuximab concentration when used in combination<br>To further assess the anti-tumor activity of LJM716 when administered in combination with cetuximab<br>;Primary end point(s): Phase Ib<br>1) Change from baseline of target lesions per RECIST 1.1<br>2) Incidence of DLTs<br><br>Phase II<br>1) Overall response rate (ORR) per RECIST 1.1;Timepoint(s) of evaluation of this end point: Phase Ib<br>1) 6 months<br>2) 35 days<br><br> Phase II<br>1) 6 months

Secondary Outcome Measures

Name	Time	Method
Secondary end point(s): Phase Ib and II<br>1) Events (AEs), serious AEs (SAEs) changes in hematology and chemistry values, vital signs, electrocardiograms (ECGs), dose interruptions, reductions and dose intensity.<br>2) Plasma concentration versus time profiles, plasma PK parameters of LJM716; concentration of cetuximab<br>3) Best overall response (BOR), duration of response (DOR), overall survival (OS) and PFS per RECIST 1.1;Timepoint(s) of evaluation of this end point: Phase Ib and II<br>1) 6 months<br>2) 6 months<br>3) 6 months for BOR, DOR, PFS; <br> 12 months for OS