Approval Probability 71%
TA Base Rate26%
Adjusted LOA41%
ML RiskLOW_RISK
| NCT ID | Title | Phase | Status | Enrollment | Velocity | Design | Start | Completion | Last Updated | Sites | Countries |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT02879760 | Oncolytic MG1-MAGEA3 With Ad-MAGEA3 Vaccine in Combination With Pembrolizumab for Non-Small Cell Lung Cancer Patients | PHASE1 | COMPLETED | 16 | — | — | Mar 8, 2017 | May 24, 2020 | Oct 6, 2020 | 6 | Canada |
To determine the maximum tolerated dose MTD/ maximum feasible dose MFD of Ad/MAGEA3 and MG1-MAGEA3 in combination with pembrolizumab
To evaluate objective tumour response rate (ORR) based on RECIST 1.1
| Arm | Type | Description |
|---|---|---|
| Ad/MAGEA3, MG1-MAGEA3 and pembrolizumab | EXPERIMENTAL | Ad-MAGEA3 prime will be administered as a single IM dose on Day 1 at 2 x 10e11 VP. MG1/MAGEA3 boost will be administered IV on Day 15 and Day 18 by 5 cohorts: Cohort 1: Days 15 \& 18 at 1x 10e10 pfu. Cohort 2: Days 15 \& 18 at 1x 10e11 pfu. Cohort 3: Day 15 at 1 x 10e11 pfu; Day 18 at 3 x 10e11 pfu. Cohort 4: Day 15 at 1 x 10e11 pfu; Day 18 at 3 x 10e11 pfu. Cohort 5: Day 15 at 3x 10e11 pfu; Day 18 at 3 x 10e12 pfu. Pembrolizumab will be administered IV every 3 weeks starting on Day 22. |
| Name | Type | Description |
|---|---|---|
| Ad-MAGEA3 | BIOLOGICAL | Intramuscular injection |
| MG1-MAGEA3 | BIOLOGICAL | Intravenous infusion |
| Pembrolizumab | BIOLOGICAL | Intravenous infusion |
Inclusion Criteria: In order to be eligible for participation in this trial, the patient must: 1. Have histologically or cytologically confirmed diagnosis of NSCLC (squamous or non-squamous) with positive expression of MAGE-A3 (primary or metastatic lesion). 2. Phase 1: Have radiographic progressi...