Cancer
Conditions
Sponsors
Biocon Biologics UK PLC
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Male and female patients aged = 18 years at the time of signing the informed consent form. 2. Patients with ECOG Performance Status 0 or 1 at screening and before randomization. 3. All patients must have been diagnosed with either Stage IIB, or Stage IIC, or Stage III melanoma (AJCC Cancer Staging, 8th edition) and have histologically confirmed melanoma which is completely surgically resected. Note: Participants must have documented evidence to confirm surgically with negative margins (per local standard) on resected specimens. a. All melanomas, except ocular/uveal and mucosal melanoma, regardless of primary site of disease will be allowed. b. Patients with Stage IIB/C melanoma who presented with synchronous or metachronous Stage < 2 melanomas that have been completely resected will be allowed. c. In Stage III melanoma: i. If Stage IIIA then the patients will be included only if they were sentinel node positive with a nodal metastasis at least 1 mm in diameter. ii. If Stage IIIb or IIIc or IIId, the patients should have clinical or radiographic evidence of regional metastases, either in the regional lymph nodes or locoregional metastases manifesting as satellite or in-transit metastases, or microsatellites discovered at the time of microscopic evaluation. Patients must have pathological evidence of regional metastases, regional lymph node and/or microsatellite/satellite/in-transit metastases, and no distant metastasis. 4. Patients must have undergone melanoma resection at least 28 days prior to signing the informed consent. 5. All patients must have disease-free status (ie, no loco-regional relapse or distant metastasis). 6. Have adequate organ function. 7. In case of female patients, negative serum pregnancy test. 8. Women with postmenopausal status can be included. 9. Male and female patients of childbearing potential must be willing to use an adequate method of contraception. 10. Able to understand and willing to provide consent in the ICF.
Exclusion criteria
Exclusion criteria: 1. History of ocular/uveal and mucosal melanoma. 2. Patients with active, known, or suspected autoimmune disease. 3. Prior malignancy active within the previous 3 years. 4. Patients who received prior therapy with anti-PD-1 (including pembrolizumab), anti- PD-L1, anti PD L2, anti CD137, or anti-CTLA-4 antibody (including ipilimumab or any other antibody) or agents that target interleukin-2 (IL-2) pathway any other antibody or drug specifically targeting T cell co-stimulation or checkpoint pathways. 5. Patients with a condition requiring systemic treatment with either corticosteroids or other immunosuppressive medications within 14 days of randomization. 6. Undergone treatment directed against the resected melanoma (eg, chemotherapy, targeted agents, biotherapy, or limb perfusion) that is administered after the complete resection. 7. History or current evidence of any condition, therapy, or laboratory abnormality that might confound the results of the clinical study, interfere with the patient’s participation throughout the clinical study. 8. Known history of allergy or hypersensitivity to study intervention components. 9. Known history of severe hypersensitivity reaction (Grade = 3) to any monoclonal antibody. 10. Any positive test result for hepatitis B virus (HBV) or hepatitis C virus (HCV) indicating presence of virus. 11. Patient positive for human immunodeficiency virus (HIV) infection (HIV 1 and 2 tests). 12. Has a known psychiatric or substance abuse disorder that would interfere with the co-operation with the requirements of the trial. 13. Is pregnant or breastfeeding or expecting to conceive or father children. 14. Has received prior anticancer therapy including mAb, chemotherapy, or an investigational agent or device within 5 half-lives before first dose of study intervention. 15. Has received a live vaccine within 30 days prior to the first dose of study intervention. 16. Has documented or known current alcohol/drug abuse.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| To demonstrate PK equivalence between Bmab1800 and Keytruda | — |
Secondary
| Measure | Time frame |
|---|---|
| To evaluate and compare secondary PK parameters between Bmab1800 and Keytruda;To evaluate and compare safety and tolerability of Bmab1800 and Keytruda;To evaluate and compare immunogenicity of Bmab1800 and Keytruda | — |
Countries
South Africa
Contacts
Public ContactBernardo Rapoport
National PI
Outcome results
None listed