Health Condition 1: C148- Malignant neoplasm of overlappingsites of lip, oral cavity and pharynx
Conditions
Interventions
Intervention1: Biosimilar Cetuximab: Dosage Form: It will be supplied in concentration of 5 mg/mL as a 100 mg/20 ml single-use vial, as a sterile, injectable liquid containing no preservatives.
Dosage
Sponsors
Enzene Biosciences Limited
Alkem Laboratories Limited
Eligibility
Inclusion criteria
Inclusion criteria: 1.Patients of 18-65 years of age at the time of signing the ICF 2.Has life expectancy of at least 6 months from screening 3. Histologically confirmed diagnosis of SCCHN 4. Presence of recurrent locoregional (not suitable for local therapy) or metastatic disease as per Tumor Node Metastasis staging at screening 5. In case of recurrent locoregional carcinoma, patients must have documented progression of platinum-based chemotherapy for recurrent disease 6. Has at least 1 measurable target lesion (tumor/lymph node) as per RECIST version 1.1 at screening 7. Eastern cooperative oncology group (ECOG) status 0 to 2 at screening 8. Willing and able to comply with the protocol 9. Willing to provide written informed consent
Exclusion criteria
Exclusion criteria: 1.Patients with Nasopharyngeal cancer 2.Prior systemic chemotherapy (except if given as part of a multimodal treatment for locally advanced disease which was completed more than 6 months prior to screening) 3.Patient who has received cetuximab or other EGFR targeting agent treatment (except if given as part of a multimodal treatment for locally advanced disease which was completed more than 6 months prior to screening) 4.Surgery (other than minor interventions like diagnostic biopsy or intravenous port implantation) or irradiation within 30 days before randomization 5.Concomitant anti-tumor therapy or concomitant immunotherapy 6.Known sensitivity to any component of the investigational product (IP) and medication used in this study 7.Clinical evidence of brain metastasis or leptomeningeal involvement 8.History of Interstitial Lung Disease 9.History of severe (Grade 3 or 4) allergic or hypersensitivity reaction to therapeutic antibodies 10.Patientââ?¬•s having the following laboratory results at screening a.Absolute neutrophil count (ANC) b.Hemoglobin (Hb) c.Total Leucocyte count d.Platelet count e.Total bilirubin level > 1.5 times the upper limit of the normal laboratory range (ULN) f. Alanine aminotransferase (ALT)/aspartate aminotransferase (AST) levels ââ?°Â¥ 5 times ULN g.Serum Creatinine level > 1.5 times ULN h.Abnormal serum electrolytes (within normal limit) i. INR and aPTT (within normal limit) 11.Patients suffering from acute or chronic infection(s) 12.Myocardial infarction within 6 months prior to screening 13.Symptomatic congestive heart failure (New York Heart Association [NYHA] Grade 3 or 4), unstable angina pectoris within 6 months prior to screening, significant cardiac arrhythmia, history of stroke or transient ischemic attack within 1 year prior to screening 14. Pre-existing grade 2 or greater motor or sensory neuropathy 15. Active hemoptysis (defined as bright red blood of Ã?½ teaspoon or more in saliva) within 30 days prior to randomisation. 16.History of clinically significant gastrointestinal bleeding (bleeding requiring procedural intervention (e.g., variceal banding, transjugular intrahepatic portosystemic shunt procedure, arterial embolization, topical coagulation therapy) within 6 months prior to randomisation. 17.Patients with history of keratitis 18.Positive serology for human immunodeficiency virus (HIV), hepatitis B virus (HBV) and hepatitis C virus (HCV) at screening 19.Female patients of childbearing potential not willing to implement adequate non-hormonal contraceptive measures during the study period 20.Patients who are pregnant or nursing 21.Has any concurrent disease or condition, which in the opinion of the investigator does not allow participation of the patient in this study 22.Has participated in any other clinical trial and received experimental medications within 4 weeks prior to screening.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 1. To compare the efficacy of biosimilar cetuximab versus innovator cetuximab in patients with recurrent locoregional or metastatic SCCHN by assessment of Disease Control Rate (DCR) 2.To compare the efficacy of biosimilar cetuximab versus innovator cetuximab in patients with recurrent locoregional or metastatic SCCHN by assessment of overall response rate (ORR)Timepoint: 1. All patients completed 12 week of treatment 2. All patients completed 18 weeks of treatment | — |
Secondary
| Measure | Time frame |
|---|---|
| 1. Pharmacokinetics (PK) of biosimilar versus innovator cetuximab 2.Immunogenicity of biosimilar cetuximab and innovator cetuximab by assessment of anti-cetuximab antibody (ADA) Timepoint: Anti-cetuximab antibody (ADA): baseline and Week 18 visit PK Assessment:Baseline, Week2,3 and 4 | — |
Countries
India
Contacts
Public ContactDr Vinayaka Shahavi
Alkem Laboratories Ltd
Outcome results
None listed