Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
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.
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| LJM716+cetuximab | Experimental |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| LJM716 | Biological | antibody |
| |
| cetuximab |
| 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 |
| 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 |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Affiliation | Role |
|---|---|---|
| Novartis Pharmaceuticals | Novartis Pharmaceuticals | Study Director |
Not provided
| ID | Term |
|---|---|
| D000077195 | Squamous Cell Carcinoma of Head and Neck |
| D006258 | Head and Neck Neoplasms |
| ID | Term |
|---|---|
| D002294 | Carcinoma, Squamous Cell |
| D002277 | Carcinoma |
| D009375 | Neoplasms, Glandular and Epithelial |
| D009370 | Neoplasms by Histologic Type |
Not provided
Not provided
| ID | Term |
|---|---|
| C000619694 | elgemtumab |
| D000068818 | Cetuximab |
| ID | Term |
|---|---|
| D061067 | Antibodies, Monoclonal, Humanized |
| D000911 | Antibodies, Monoclonal |
| D000906 | Antibodies |
| D007136 | Immunoglobulins |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Biological |
antibody |
|
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 |
| D009369 | Neoplasms |
| D009371 | Neoplasms by Site |
| D007162 |
| Immunoproteins |
| D001798 | Blood Proteins |
| D011506 | Proteins |
| D000602 | Amino Acids, Peptides, and Proteins |
| D012712 | Serum Globulins |
| D005916 | Globulins |