Health Condition 1: C00-C14- Malignant neoplasms of lip, oral cavity and pharynx
Conditions
Interventions
Intervention1: Biosimilar Nivolumab: Proposed Biosimilar Nivolumab, 10
mg/mL concentrate for solution for
infusion.
240 mg every 2 weeks, over 30-60
minutes.
Control Intervention1: Innovator Nivoluma
Sponsors
Alkem Laboratories Limited
Enzene Biosciences Limited
Eligibility
Inclusion criteria
Inclusion criteria: The patients will be included in the study based on the following criteria 1. Male or female patients aged between 18 to 65 (both inclusive) years at the time of signing inform consent form. 2. Patients with life expectancy of at least 6 months from screening. 3. Patients with histologically confirmed diagnosis of SCCHN. 4. Patients with presence of recurrent locoregional (not suitable for local therapy) or metastatic disease as per Tumor Node Metastasis staging at screening. 5. Patients must have documented progression within 6 months after the last dose of platinum-based chemotherapy administered as adjuvant therapy or in context of primary, recurrent or metastatic disease. 6. Patients with at least 1 measurable target lesion (tumor/lymph node) as per RECIST version 1.1 at screening. 7. Patients with Eastern cooperative oncology group (ECOG) status 0 to 1 at screening. 8. Women of childbearing potential (WOCBP) must be using an acceptable method of contraception to avoid pregnancy throughout the study. WOCBP must have a negative urine pregnancy test at screening / baseline visit. 9. Male patients with female partners who agree to use effective contraception during study. 10. Patients willing to comply with all the protocol related requirements.
Exclusion criteria
Exclusion criteria: The patients will be excluded from the study based on the following criteria 1. Patients with prior treatment with Nivolumab or any other anti-PD-L1, anti-PD-L2, or any other anti-CTLA-4 antibody (including ipilimumab or any other antibody or drug targeting T-cell co-stimulation or checkpoint pathways). 2. Patients with carcinoma of the nasopharynx or salivary gland as the tumor sites. 3. Patients who underwent surgery (other than minor interventions like diagnostic biopsy or intravenous port implantation) or irradiation within 30 days before randomization. 4. Patients on any other concomitant anti-tumor therapy or concomitant immunotherapy. 5. Patients with known sensitivity to any component of the investigational medicinal product (IMP) and medication used in this study. 6. Patients with clinical evidence of brain metastasis or leptomeningeal involvement 7. Patients with a history of severe (Grade 3 or 4) allergic or hypersensitivity reaction to therapeutic antibodies. 8. Patients with active, known or suspected autoimmune disease (skin disorders (such as vitiligo, psoriasis, or alopecia) not requiring systemic treatment or conditions not expected to recur in the absence of an external trigger are permitted to enroll.). 9. Patients on concomitant systemic use of immunosuppressants. 10. Patients with h/o type I diabetes mellitus, hypothyroidism only requiring hormone replacement. 11. Patients having the following laboratory results at screening a. Absolute neutrophil count less than(ANC) 1,500/mm3 b. Hemoglobin (Hb) less than 9 g/dL c. Total Leucocyte count less than 3000/mm3 d. Platelet count less than 100,000/mm3 e. Total bilirubin level greater than 1.5 times the upper limit of the normal laboratory range (ULN) f. Alanine aminotransferase (ALT)/aspartate aminotransferase (AST) levels greater than or equal to 2.5 times ULN g. Serum Creatinine level greater than 1.5 times ULN 12. Patients suffering from acute or chronic infection(s). 13. Patients with myocardial infarction within 6 months prior to screening. 14. Patients having 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. 15. Patients with active hemoptysis (defined as bright red blood of teaspoon or more in saliva) within 30 days prior to Cycle 1, Day 1. 16. Patients with positive serology for human immunodeficiency virus (HIV), hepatitis B virus(HBV) and hepatitis C virus (HCV) at screening. 17. Female patients of childbearing potential not willing to implement adequate non-hormonal contraceptive measures during the study period. 18. Female patients who are pregnant or nursing. 19. Patients with any concurrent disease or condition, which in the opinion of the investigator does not allow participation of the patient in this study. 20. Patients participated in other clinical trials and received experimental medications within 4 weeks prior to screening. 21. Patients currently taking any of the prohibited medications(s) listed and inability/unwillingness to discontinue them for the entire study period. 22. Patients with mental disorder. 23. Patients with sus
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| To evaluate and compare the efficacy of proposed biosimilar Nivolumab versus innovator Nivolumab in patients with recurrent locoregional or metastatic SCCHN by assessment of Overall Response Rate (ORR)Timepoint: All patients completed 12 Week of treatment | — |
Secondary
| Measure | Time frame |
|---|---|
| 1.To evaluate and compare Disease Control Rate (DCR) of proposed biosimilar Nivolumab versus innovator Nivolumab 2. To evaluate and compare pharmacokinetics (PK) of proposed biosimilar Nivolumab versus innovator Nivolumab 3. To compare immunogenicity of biosimilar Nivolumab and innovator Nivolumab by assessment of anti-Nivolumab antibody 4. To assess the safety and tolerability of the investigational productTimepoint: Disease control rate at Week 6, 12 and 24 weeks Anti-Nivolumab Antibody(ADA)-Visit 2,Visit 14 PK Assessment- Visit 2 | — |
Countries
India
Contacts
Public ContactDr Satish Gaikwad
Alkem Laboratories Ltd
Outcome results
None listed