Double-blind Study to Evaluate the PK, Efficacy, Safety and Immunogenicity of MB12 Versus Keytruda® in Stage IV NSCLC
Trial statusRecruiting
Trial phasePhase 3
Trial typeInterventional
Biological sexAll
Age18+
SponsorLaboratorio Elea Phoenix S.A.
About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
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.
Body weight ≥50 kg at Screening.
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.
Disqualifiers
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.
Trial design
Design model
Parallel
Treatments tested in this trial
Pembrolizumab
DrugStudy drug administration: intravenous infusion Dosing instructions: 200 mg administered over 30 minutes, every 3 weeks The time for infusion should be closer to 30 minutes. However, considering the variability of the infusion pumps from one center to another, a -5 to +10 minutes window is allowed (ie, the time for infusion is 30 minutes with an allowed range of 25 to 40 minutes).
Pembrolizumab biosimilar
DrugStudy drug administration: intravenous infusion Dosing instructions: 200 mg administered over 30 minutes, every 3 weeks The time for infusion should be closer to 30 minutes. However, considering the variability of the infusion pumps from one center to another, a -5 to +10 minutes window is allowed (ie, the time for infusion is 30 minutes with an allowed range of 25 to 40 minutes).
Treatment groups
174 Participants
are divided into 2 treatment groupsGroup A: Medical Reference ProductActive comparator 1 intervention
Group B: Investigational ProductExperimental treatment 1 intervention
Trial outcomes
Primary outcomes
1
AUC (area under the curve)
The primary PK parameter is AUC (area under the curve in the serum concentration-time plot) at Cycle 6. Serum concentrations used for estimating AUC will be determined by a validated analytical procedure once steady state (5 elimination half-lives) has been reached.
Time frame
Four months2
Cmax (maximum serum concentration)
Cmax will be calculated for Cycle 1 and Cycle 6.
Time frame
Four months3
Tmax (time for maximum serum concentration)
Tmax will be calculated for Cycle 1 and Cycle 6.
Time frame
Four monthsSecondary outcomes
1
Best overall response
To compare the best overall response (BOR) during the Main Study Period and progression-free survival (PFS) during the Extended Treatment Period of MB12 and Keytruda®.
Time frame
52 weeks2
Number of participants with treatment-related adverse events as assessed by CTCAE v5.0
Safety will be monitored by incidence, nature, and severity of treatment-emergent adverse events, including adverse drug reactions graded according to CTCAE version 5.0.
Time frame
52 weeks3
Number of participants developing anti-drug antibodies
Blood samples will be taken to determine ADAs through 52 weeks after the first study drug administration. Anti pembrolizumab antibodies will be presented as negative (lower than the test cut-off) or positive (above the test cut-off) and will be presented by treatment group. Results will be presented by summarizing frequency (n) and percentage (%) of subjects with a positive result.
Time frame
52 weeksSponsors and contacts
Click on the lead sponsor to view all of their trials.
Laboratorio Elea Phoenix S.A.
Lead sponsor
Syneos Health
Collaborator
Source ClinicalTrials.gov