Actively Recruiting
Randomized, Multicenter, Double-blind Study Comparing MB12 (Pembrolizumab Biosimilar) and Keytruda® in Stage IV Non-Squamous NSCLC
Led by Laboratorio Elea Phoenix S.A. · Updated on 2024-07-16
174
Participants Needed
1
Research Sites
17 weeks
Total Duration
On this page
Sponsors
L
Laboratorio Elea Phoenix S.A.
Lead Sponsor
S
Syneos Health
Collaborating Sponsor
AI-Summary
What this Trial Is About
Researchers are evaluating MB12, a proposed biosimilar to pembrolizumab, compared to the reference drug Keytruda® in people newly diagnosed with stage IV non-squamous non-small cell lung cancer (NSCLC). This randomized, double-blind, multinational study aims to assess the pharmacokinetics (PK), efficacy, safety, and immune response of MB12 versus Keytruda®. The trial will enroll about 174 participants across approximately 48 sites in seven countries. Participants will be randomly assigned to receive either MB12 or Keytruda® as an intravenous infusion of 200 mg over about 30 minutes every three weeks. The study has two periods: the Main Study Period, covering screening through six treatment cycles, and an Extended Treatment Period for those showing clinical benefit (complete response, partial response, or stable disease) continuing up to 52 weeks or until disease progression or intolerance. Treatment is given as monotherapy in both periods, with assessments for tumor response and safety conducted regularly. During the study, participants will undergo scans to measure tumor response every six weeks during the Main Study Period and every nine weeks during the Extended Treatment Period. Safety checks include vital signs, physical exams, ECGs, lab tests, and monitoring for adverse events. Blood samples will be collected to analyze drug levels and immune responses. The primary measures focus on drug concentration and timing, while secondary outcomes assess overall response, side effects, and antibody development. Safety data will be reviewed periodically by an independent board throughout the trial.
CONDITIONS
Brief Title
Double-blind Study to Evaluate the PK, Efficacy, Safety and Immunogenicity of MB12 Versus Keytruda® in Stage IV NSCLC
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Willing and able to provide written informed consent before any study procedures
- Aged 18 years or older at consent
- Body weight of at least 50 kg at screening
- Newly diagnosed stage IV non-squamous NSCLC without prior systemic treatment
- At least one measurable lesion per RECIST 1.1
- PD-L1 expression of 50% or higher as determined locally
- Life expectancy of at least 3 months
- ECOG performance status of 0 or 1
- Adequate liver, kidney, blood, endocrine, and coagulation function
- Negative COVID-19 test within 24 hours before randomization or resolved infection
- No prior malignancy except certain skin or bladder cancers treated without recurrence for 3 years
- Women of childbearing potential must use highly effective contraception or abstain during and 6 months after treatment
- Male subjects not surgically sterile must use contraception or abstain during and 6 months after treatment
You will not qualify if you...
- Unable or unwilling to comply with study visits, treatments, or procedures
- Predominantly squamous cell NSCLC or small cell elements present
- Participation in another clinical trial or investigational treatment within 4 weeks or 5 half-lives before randomization
- Known mutations with approved therapies available
- Known brain metastases or carcinomatous meningitis
- Recent systemic steroid or immunosuppressive therapy (except low dose steroid replacement)
- Need for other cancer therapies during the study
- Prior anti-PD-1, anti-PD-L1, anti-PD-L2, anti-CD137, or anti-CTLA-4 therapy
- Recent chemotherapy, biologic therapy, major surgery, or thoracic radiation
- Severe hypersensitivity to monoclonal antibodies
- Active autoimmune disease requiring treatment in last 2 years
- Interstitial lung disease or pneumonitis needing steroids
- Active infection needing intravenous treatment in last 30 days
- Recent live virus vaccination
- Known HIV, active tuberculosis, hepatitis B or C infections
- Solid organ or tissue transplant recipient
- Psychiatric disorders interfering with study cooperation
- Recent substance abuse or illicit drug use
- Pregnant, lactating, or planning pregnancy during study
- Immediate family member involved in the study at research site or sponsor staff
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - Up to 18 weeks (6 cycles of 3 weeks each)
Participants receive intravenous infusions of MB12 or Keytruda® at a dose of 200 mg every 3 weeks. Treatment occurs during the Main Study Period up to Cycle 6 unless there is disease progression, intolerance to the study drug, or treatment discontinuation for other reason.
6 visits (in-person) every 3 weeks
Duration - Up to 34 additional weeks after main treatment period
Participants who demonstrate clinical benefit (complete response, partial response, or stable disease) continue receiving MB12 or Keytruda® every 3 weeks during the Extended Treatment Period, up to a maximum of 52 weeks from first infusion or until disease progression, intolerance, or treatment discontinuation.
Up to 12 visits (in-person) every 3 weeks
Trial Site Locations
Total: 1 location
1
Clínica Viedma
Viedma, Río Negro Province, Argentina, 5300
Actively Recruiting
Research Team
M
Marcelo Guthmann, PhD
M
Marcelo Tinelli, MD
How is the study designed?
Study Type
INTERVENTIONAL
Masking
QUADRUPLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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