| 0 |
Just noticed the Clinical Trials website for the MAST study has been updated on the 20th of March. Have they now included overall survival? 9 sites now recruiting. Anyone with trials expertise able to comment further? Many thanks.
|
Primary Outcome Measures: |
|
1. |
Frequency and severity of Adverse Events of IV and IT CF33-hNIS as a monotherapy or in combination with pembrolizumab[ Time Frame: From first dose of study drug through 30 days following the last dose of study treatment. ]Adverse events will be graded according to CTCAE v5.0.2. |
Maximum Tolerated Recommended Phase 2 Dose ( MTD RP2D) of CF33-hNIS as a monotherapy or in combination with pembrolizumab[ Time Frame: From first dose of study drug through 21-42 days following the first dose of study treatment. ]The MTD is defined as the dose level below the dose inducing Dose Limiting Toxicity (DLT) in > 33% of patients. RP2D determination will be based on evaluation of Dose Limiting Toxicities (DLT) as well as other safety, efficacy and correlative data.Secondary Outcome Measures: |
1. |
Objective Response Rate (ORR) of CF33-hNIS administered as a monotherapy or in combination with pembrolizumab[ Time Frame: Up to 2 years from first dose of study drug. ]ORR is defined as the proportion of patients in the efficacy population who achieve a radiographic Investigator-assessed confirmed complete response (CR) or partial response (PR), per RECIST v1.1 or confirmed immune complete response (iCR) or immune partial response (iPR) per iRECIST v1.0.2. |
Progression-free survival (PFS) of CF33-hNIS administered as a monotherapy or in combination with pembrolizumab.[ Time Frame: Up to 2 years from first dose of study drug. ]PFS, defined as the time from start of treatment to the first documentation of progressive disease (PD) or death from any cause, whichever occurs first.3. |
Overall survival (OS) of CF33-hNIS administered as a monotherapy or in combination with pembrolizumab.[ Time Frame: Up to 2 years from first dose of study drug. ]defined as the time from the start of treatment until death due to any cause. Median OS and OS rate at 12 months will be reported.3 4. |
Duration of Response (DOR) of CF33-hNIS administered as a monotherapy or in combination with pembrolizumab.[ Time Frame: Up to 2 years from first dose of study drug. ]DOR is defined as the time from the date a response of PR/iPR or better was first recorded to the date on which progressive disease was first noted or the date of death due to any cause.4 5. |
Disease Control Rate (DCR) of CF33-hNIS administered as a monotherapy or in combination with pembrolizumab.[ Time Frame: Up to 2 years from first dose of study drug. ]DCR is defined as the proportion of patients who achieve an Investigator-assessed confirmed CR/iCR, PR/iPR, or Stable Disease (SD)/immune SD (iSD) per RECIST v1.1 and iRECIST v1.0.5 6. |
To evaluate viral titers of CF33-hNIS[ Time Frame: Up to 2 years from first dose of study drug. ]Viral Plaque Assay (VPA) and polymerase chain reaction (PCR) testing from serum, urine, oral swab, rectal swab, injection site(s) swab and wound dressing swab.6 7. |
To evaluate infection of tumors with CF33-hNIS[ Time Frame: 21 days from first dose of study drug ]hNIS-based imaging via SPECT technetium-99 (99TC).Other Outcome Measures: |
1. |
To evaluation antiviral immune activation[ Time Frame: Up to 2 years from first dose of study drug. ]Up regulation of PD-L1 expression as compared to baseline in tumor tissue and circulating tumor cells (CTC).
Analysis of lymphocyte subsets and cytokine profile compared to baseline.
|
(20min delay)