Actively Recruiting
Double-blind Study to Evaluate the PK, Efficacy, Safety and Immunogenicity of MB12 Versus Keytruda® in Stage IV NSCLC
Led by Laboratorio Elea Phoenix S.A. · Updated on 2024-07-16
174
Participants Needed
1
Research Sites
67 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
This is a randomized, multicenter, multinational, double-blind, and parallel-group study to evaluate the PK, efficacy, safety and immunogenicity of MB12 (proposed pembrolizumab biosimilar) versus Keytruda® in subjects with newly diagnosed stage IV non-squamous NSCLC. This study is planned to be conducted in approximately 48 sites in 7 countries, a total of 174 subjects will be enrolled. Eligible subjects will be randomized in a 1:1 ratio to receive MB12 or Keytruda® at a dose of 200 mg every 3 weeks. Subjects will be stratified by gender (male versus female) and ECOG status (0 versus 1) as both factors are considered to have the potential to influence PK properties of pembrolizumab to some extent. The study will consist of 2 periods defined as follows: * Main Study Period from Screening up to Cycle 6 included. * Extended Treatment Period from Cycle 7 up to Week 52 for those subjects who demonstrate clinical benefit from the treatment (complete response \[CR\], partial response \[PR\], and stable disease \[SD\]). They will continue treatment until disease progression, intolerance to the study drug, treatment discontinuation for other reason, or up to Week 52, whichever occurs first. A Data Safety Monitoring Board (DSMB) will assess the safety data periodically and will recommend to the sponsor whether to continue, modify, or stop the trial on the basis of safety considerations. After the first 10 subjects have received at least 2 cycles of treatment, the DSMB will review the accumulated safety data, and the first meeting will take place. Subsequent meetings will be performed as per the DSMB charter.
CONDITIONS
Official 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
- Age 18 years or older at consent
- Body weight of at least 50 kg at Screening
- Newly diagnosed stage IV non-squamous NSCLC with no prior systemic treatment
- At least one measurable lesion per RECIST version 1.1
- PD-L1 expression 50% or higher by FDA-approved immunohistochemistry
- Life expectancy of at least 3 months
- ECOG performance status of 0 or 1
- Adequate liver, kidney, blood, endocrine, and coagulation function as defined
- Negative COVID-19 test within 24 hours before randomization or documented resolution if previously infected
- No history of prior malignancy except certain skin and bladder cancers or cervical cancer in situ, or disease-free for 3 years after curative treatment
- Women of childbearing potential must use effective contraception or abstain during study and 6 months after last dose
- Surgically sterile or postmenopausal women are eligible
- Male subjects must use effective contraception or abstain during study and 6 months after last dose
You will not qualify if you...
- Unable or unwilling to comply with study visits, drug administration, tests, or procedures
- Predominant squamous cell histology NSCLC or presence of small cell elements
- Participation in another clinical trial or investigational treatment within 4 weeks or 5 half-lives before randomization
- Known mutations with approved therapies
- Known brain metastases or carcinomatous meningitis
- Recent systemic steroid therapy above 10 mg prednisone equivalent or other immunosuppressive drugs
- Need for other cancer treatments during the study
- Prior anti-PD-1, anti-PD-L1, anti-PD-L2, anti-CD137, or CTLA-4 therapy
- Recent chemotherapy, biological therapy, major surgery, or high-dose thoracic radiation
- Severe allergy to monoclonal antibodies
- Active autoimmune diseases requiring recent systemic treatment
- Interstitial lung disease or pneumonitis needing steroids
- Active or recent serious infections requiring IV treatment
- Recent live virus vaccination
- Known HIV infection
- Active tuberculosis or hepatitis B or C infection
- History of organ or tissue transplantation
- Psychiatric disorders interfering with study
- Recent substance abuse or illicit drug use
- Pregnancy, lactation, or planning pregnancy during study and up to 120 days after last dose
- Immediate family member involved in study conduct at site or sponsor
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 1 location
1
Clínica Viedma
Viedma, Río Negro Province, Argentina, 5300
Actively Recruiting
Research Team
M
Marcelo Guthmann, PhD
CONTACT
M
Marcelo Tinelli, MD
CONTACT
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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