Neoplasm
Conditions
Brief summary
The ORR is defined as the proportion of patients who achieve either a confirmed PR or CR as best response as assessed by Investigators per RECIST 1.1 . Objective response will be evaluated per each disease assessment and the ORR will be expressed as a binomial proportion with the corresponding 2-sided 95% CI based on the Clopper-Pearson exact method. Patients without any baseline or any post-baseline measurements are considered non-responders.
Detailed description
The secondary efficacy endpoints are defined as follows: 1. CR rate is based on responders who achieved confirmed CR as assessed by Investigators., DOR is defined among patients who achieved objective response. It is measured from the first-time response (PR/CR) criteria are met until the first date that progressive disease is objectively documented, or the patient dies., PFS is defined as the time (in months) from the time of TIL infusion (or from the first infusion of pembrolizumab for Cohorts 1A, 2A, and 3A or from the first infusion of ipilimumab and nivolumab for Cohort 3C) to PD, or death due to any cause, whichever event is earlier., OS is defined as the time (in months) from the time of TIL infusion (or from the first infusion of pembrolizumab for Cohorts 1A, 2A, and 3A or from the first infusion of ipilimumab and nivolumab for Cohort 3C) to death due to any cause.
Interventions
DRUGLN-145
DRUGALDESLEUKIN
DRUGLifileucel
DRUGNIVOLUMAB
DRUGKEYTRUDA 25 mg/mL concentrate for solution for infusion
DRUGIPILIMUMAB
Sponsors
Iovance Biotherapeutics Inc.
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The ORR is defined as the proportion of patients who achieve either a confirmed PR or CR as best response as assessed by Investigators per RECIST 1.1 . Objective response will be evaluated per each disease assessment and the ORR will be expressed as a binomial proportion with the corresponding 2-sided 95% CI based on the Clopper-Pearson exact method. Patients without any baseline or any post-baseline measurements are considered non-responders. | — |
Secondary
| Measure | Time frame |
|---|---|
| The secondary efficacy endpoints are defined as follows: 1. CR rate is based on responders who achieved confirmed CR as assessed by Investigators., DOR is defined among patients who achieved objective response. It is measured from the first-time response (PR/CR) criteria are met until the first date that progressive disease is objectively documented, or the patient dies., PFS is defined as the time (in months) from the time of TIL infusion (or from the first infusion of pembrolizumab for Cohorts 1A, 2A, and 3A or from the first infusion of ipilimumab and nivolumab for Cohort 3C) to PD, or death due to any cause, whichever event is earlier., OS is defined as the time (in months) from the time of TIL infusion (or from the first infusion of pembrolizumab for Cohorts 1A, 2A, and 3A or from the first infusion of ipilimumab and nivolumab for Cohort 3C) to death due to any cause. | — |
Countries
Germany, Greece, Spain
Outcome results
None listed