Randomized, Multicenter, Multinational, Double-Blind Study to Evaluate the Pharmacokinetics, Efficacy, Safety and Immunogenicity of MB12 (Proposed Pembrolizumab Biosimilar) Versus Keytruda® in Subjects With Stage IV Non-Squamous Non-Small Cell Lung Cancer
- Conditions
- B47 MycetomaMycetoma
- Registration Number
- PER-010-23
- Lead Sponsor
- aboratorio Elea Phoenix S.A.
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Without startig enrollment
- Sex
- All
- Target Recruitment
- 0
Body weight =50 kg at Screening.
At least 1 radiographically measurable lesion per RECIST version 1.1, locally assessed.
Life expectancy of at least 3 months.
ECOG performance status of 0 to 1.
Subjects with a negative COVID-19 test (done at the discretion of investigator or per local regulation) within previous 24 hours before randomization. In case of confirmed COVID-19 infection before Screening, documentation of resolution of infection by appropriate laboratory test is required.
No history of prior malignancy, except for basal cell carcinoma of the skin, superficial bladder cancer, squamous cell carcinoma of the skin, or cervical cancer in situ, or has undergone potentially curative therapy without evidence of disease recurrence for 3 years from the start of that therapy.
Male subjects, if not surgically sterile, must either abstain from sexual intercourse or employ highly effective contraception (condoms or other barrier forms of contraception) during the study and for at least 6 months after the last dose of the study drug. Male subjects should also avoid semen donation or providing semen for in-vitro fertilization during the above-mentioned duration.
Willing and able to provide written informed consent for the study before the initiation of any study-specific procedures.
Greater than or equal to 18 years of age at the time of signing the ICF.
Having newly diagnosed stage IV (defined by the eighth edition of the TNM classification) non-squamous NSCLC, without prior systemic treatment for the disease. For those subjects in whom the pleural or pericardial effusion is the only location of metastatic disease, confirmation of its malignant etiology is required.
Programmed death-ligand 1 (PD-L1) expression =50%, locally dete
Active infection or a previous infection requiring intravenous systemic treatment within 30 days before the first dose of the study drug.
Unwilling or unable to comply with scheduled visits, drug administration plan, laboratory tests, or other study procedures and study restrictions.
Predominantly squamous cell histology NSCLC. Mixed tumors will be categorized by the predominant cell type; if small cell elements are present, the subject is ineligible.
Participation in another clinical trial or treatment with another investigational agent within 4 weeks or 5 half-lives before randomization, whichever is longer.
Known actionable mutations for which there is an approved and available therapy.
Known central nervous system metastases and/or carcinomatous meningitis.
Previous systemic steroid therapy (prednisone at a dose of 10 mg or equivalent) within 3 days before the first dose of the study drug or receiving any other form of immunosuppressive medication. Subjects receiving daily steroid replacement therapy (daily prednisone at a dose of 5 to 7.5 mg or equivalent) could be included in the study.
Subject who requires any other form of localized or systemic antineoplastic therapy during the study.
Prior anti-programmed cell death-1 (anti-PD-1), anti-PD-L1, anti-programmed death-ligand 2 (anti-PD-L2), anti-CD137, or anti-cytotoxic T-lymphocyte antigen (CTLA)-4 therapy (including ipilimumab or any other antibody or drug that specifically targets co-stimulation of T-cells or immune checkpoints).
Prior systemic cytotoxic chemotherapy, biological therapy, or major surgery within 3 weeks before the first dose of the study drug; have received thoracic radiation therapy of >30 gray (Gy) within 6 months before the first dose of the study drug. Palliative radiotherapy is allowed if completed >14 days before the first dose of the study drug.
Known history of severe hypersensitivity to another monoclonal antibody.
Active autoimmune disease which has required systemic treatment in the last 2 years before the first dose of the study drug (eg, disease modifying agents, corticosteroids, or immunosuppressive treatment). Replacement therapy (eg, thyroxine, insulin, or physiological corticosteroid replacement therapy for pituitary or adrenal insufficien
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Serum concentrations will be determined by a validated analytical procedure once steady state (5 elimination half-lives) has been reached.<br> NAME OF THE RESULT: Area under the curve at steady state (AUCss)<br> PERIOD OF TIME WHERE TE MEASUREMENT WILL BE CONDUCTED AND WHICH WILL ALLOW OBTAINING THE<br> PRIMARY RESULT: 5 elimination half-lives
- Secondary Outcome Measures
Name Time Method