Study of Efficacy and Safety of LJM716 and Cetuximab in Head and Neck Squamous Cell Carcinoma Patients
- Conditions
- Head and Neck Squamous Cell Carcinoma
- Interventions
- Biological: LJM716Biological: cetuximab
- Registration Number
- NCT02143622
- Lead Sponsor
- Novartis Pharmaceuticals
- Brief Summary
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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- WITHDRAWN
- Sex
- All
- Target Recruitment
- Not specified
- 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.
- 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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Arm && Interventions
Group Intervention Description LJM716+cetuximab LJM716 - LJM716+cetuximab cetuximab -
- Primary Outcome Measures
Name Time Method Phase Ib: Number of Total Dose-limiting Toxicity (DLT) During Dose Escalation to Determine Maximum Tolerated Dose (MTD) 35 days 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
Phase Ib: Target lesion change compared to baseline in patients, per RECIST 1.1 6 months Assessment of the preliminary anti-tumor activity of LJM716 in combination. Change in target lesion measurements, from baseline as per RECIST 1.1
Phase II: Percentage of Patients with an Objective Overall Response (OOR) per RECIST 1.1 6 months 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.
- Secondary Outcome Measures
Name Time Method Duration of response (DOR) per RECIST 1.1 6 months Duration of response will be used to further assess the anti-tumor activity of LJM716-cetuximab combination
blood concentration versus time profiles blood PK parameters of LJM716 and cetuximab concentration 6 months 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
Best overall response (BOR), per RECIST 1.1 6 months BOR will be used to further assess the anti-tumor activity of LJM716-cetuximab combination.
Safety and tolerability of the LJM716- cetuximab combination 6 months 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.
Overall survival (OS) per RECIST 1.1 12 months Overall survival will be used to further assess the anti-tumor activity of LJM716-cetuximab combination
Progression free survival (PFS) per RECIST 1.1 6 months Progression free survival will be used to further assess the anti-tumor activity of LJM716-cetuximab combination