This trial is going to take 4 more years to complete. How they are going to pay for this? ADXS did not even get free Keytruda, are they expecting Merck to sign up for this? Clear as mud.
Estimated Study Start Date : February 2019
Estimated Primary Completion Date : January 15, 2023
Estimated Study Completion Date : March 17, 2023
Outcome Measures
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Primary Outcome Measures :
Safety/Tolerability of ADXS-503 monotherapy in Part A and ADXS-503 with pembrolizumab in Part B: graded per comment terminology criteria for adverse events (CTCAE) version 4.03 [ Time Frame: 12 Months ]
Safety Measures include: Adverse events (AEs); dose-limiting toxicities (DLTs) graded per comment terminology criteria for adverse events (CTCAE) version 4.03
Preliminary anti-tumor activity of ADXS-503 + pembrolizumab in Part C [ Time Frame: 4 years ]
Anti-tumor activity per RECIST v1.1
Secondary Outcome Measures :
Preliminary anti-tumor activity of ADXS-503 alone in Part A and ADXS-503 with Pembrolizumab in Part B [ Time Frame: 3 years ]
Anti-tumor activity per RECIST v1.1
Progression-free survival (PFS) and PFS rates for subjects treated with ADXS-503 monotherapy in Part A and ADXS-503 + pembrolizumab in Part B and Part C. [ Time Frame: 4 years ]
PFS and PFS rate per RECIST v1.1
Overall survival (OS) and OS rates for subjects treated with ADXS-503 monotherapy in Part A and ADXS-503 with pembrolizumab in Part B and Part C [ Time Frame: 4 years ]
Overall survival and milestone OS rate
Safety/Tolerability of ADXS-503 with pembrolizumab in Part C: graded per comment terminology criteria for adverse events (CTCAE) version 4.03 [ Time Frame: 5 years ]
Safety Measures include: Adverse events (AEs); dose-limiting toxicities (DLTs) graded per comment terminology criteria for adverse events (CTCAE) version 4.03
Other Outcome Measures:
Preliminary anti-tumor activity of ADXS-503 monotherapy in Part A and ADXS-503 + pembrolizumab in Part B and Part C [ Time Frame: 5 years ]
Anti-tumor activity per iRECIST
Progression-free survival (PFS) and PFS rate per iRECIST for subjects treated with ADXS-503 monotherapy in Part A and ADXS-503 with pembrolizumab in Part B and Part C. [ Time Frame: 5 years ]
PFS and PFS rate per iRECIST
Immunological activity of ADXS-503, administered as monotherapy in Part A and in combination with pembrolizumab in Part B. [ Time Frame: up to 5 years ]
Pre-and on-treatment blood samples evaluate the changes in the states of activiation and differentiation in various immune cells by flow cytometry and profiling of gene expression.
Evaluate changes in serum levels of cytokines, chemokines and other analytes by multiplex assays and mass spectrometry.
Evaluate changes in the peripheral T cell repertoire by immunosequencing.
Evaluate the frequency of functional tumor antigen-specific T cells by ELISpot analysis.
