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

Study Overview
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Brief Summary
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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.

Official Title
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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

Conditions
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Head and Neck Squamous Cell Carcinoma

Intervention / Treatment
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* Biological: LJM716
* Biological: cetuximab


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: LJM716+cetuximab<br> | Biological: LJM716<br>* antibody<br>Biological: cetuximab<br>* antibody<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 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 | 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. | 6 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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. | 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 | 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. | 6 months | 
| Duration of response (DOR) per RECIST 1.1 | Duration of response will be used to further assess the anti-tumor activity of LJM716-cetuximab combination | 6 months | 
| Overall survival (OS) per RECIST 1.1 | Overall survival will be used to further assess the anti-tumor activity of LJM716-cetuximab combination | 12 months | 
| Progression free survival (PFS) per RECIST 1.1 | Progression free survival will be used to further assess the anti-tumor activity of LJM716-cetuximab combination | 6 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Head and neck cancer