Study of Efficacy and Safety of LJM716 and Cetuximab in Head and Neck Squamous Cell Carcinoma Patients

Novartis Pharmaceuticals

Overview

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.

Study Type

INTERVENTIONAL

Allocation

NON_RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Conditions

Head and Neck Squamous Cell Carcinoma

Interventions

LJM716BIOLOGICAL

antibody

cetuximabBIOLOGICAL

antibody

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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

Outcomes

Primary Outcomes

Phase Ib: Target lesion change compared to baseline in patients, per RECIST 1.1

Assessment of the preliminary anti-tumor activity of LJM716 in combination. Change in target lesion measurements, from baseline as per RECIST 1.1

Time frame: 6 months

Phase Ib: Number of Total Dose-limiting Toxicity (DLT) During Dose Escalation to Determine Maximum Tolerated Dose (MTD)

The dose escalation part of the study will be guided by a well-established statistical method/model to estimate the maximum tolerated dose of LJM716 in combination with cetuximab

Time frame: 35 days

Phase II: Percentage of Patients with an Objective Overall Response (OOR) per RECIST 1.1

Patients with an Objective Overall Response (OOR) were those whose best response to treatment was a complete response (CR) or a partial response (PR) assessed by imaging, as pr RECIST 1.1.

Time frame: 6 months

Secondary Outcomes

Safety and tolerability of the LJM716- cetuximab combination

This will be assessed by looking at the number of Adverse Events (AEs), serious AEs (SAEs) changes in hematology and chemistry values, vital signs, electrocardiograms (ECGs), dose interruptions, reductions and dose intensity.

Time frame: 6 months

blood concentration versus time profiles blood PK parameters of LJM716 and cetuximab concentration

blood concentration versus time profiles blood PK parameters will be used to characterize the PK profiles of LJM716 and cetuximab concentration when used in combination

Time frame: 6 months

Best overall response (BOR), per RECIST 1.1

BOR will be used to further assess the anti-tumor activity of LJM716-cetuximab combination.

Data from ClinicalTrials.gov

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