Table 1.
Clinical trials with ADX11-001 in cervical cancer
| Type of cancer |
Trial Phase | Author | Indication | Vaccine alone or in combination | Treatment regimen | Estimated N | Completion | Efficacy | Safety |
|---|---|---|---|---|---|---|---|---|---|
| Cervix | I | Maciag PC (31) | Recurrent/metastatic | Monotherapy | Staggered dose 3 5-subject dose cohorts: 1 x 109, 3.3 × 109 or 1 × 1010 CFU |
15/20 | 2009 | PR: 1 patient SD: 7 patients PD: 5 patients |
Pyrexia (100%) Vomiting (60%) Myalgia (57%) Cold, headache and anemia (53%) Nausea and tachycardia (49%) DLT: 1 × 109 CFU |
| I–II | Ghamande SA (32) NCT021 64461 |
Persistent/recurrent/metastatic | Monotherapy | Single group Staggered dose 5 x 109 CFU 5 x 1010 CFU ADXS11-001 every 3 wk x 2 doses |
25 | Dec-18 | - | Common TrAEs: Cold or vomiting Hypotension Tachycardia Fever Nausea |
|
| II | Huh WK (33) GOG 0265 NCT012 66460 |
Persistent/recurrent metastatic | Monotherapy | Single group: 1 x 109 CFU ADXS11-001 every 4 wk x 3 doses |
67 | Oct-18 | 1-year OS: 38.5% PFS: 3.1 m OS: 7.7 m PR: 1 patient SD: 9 patients |
TrAEs 38%: Vomiting Cold Fatigue Fever |
|
| II | Basu P (34) CTRI/2010/091/001232 |
Persistent/recurrent | ADXS11-001 ± cisplatin | Two groups: Monotherapy: ADXS11-001 (1 x 109 CFU) x 1 cycle (3 applications on days 1, 29 and 57) Combination: ADXS11-001 (1 x 109 CFU) x 1 application on day 1, followed 4 wk later by 5 doses/wk of cisplatin (40 mg/m2) |
110 | 2017 | 12-m OS: 34.9% 18-m OS: 24.8% RR: 11% (6 CR, 6 PR) SD: 35 patients |
TrAEs: 46% serious AEs G3: 7.3% |
|
| III | Herzog T (36) AIM2CERV NCT028 53604 |
High-risk, locally advanced | Monotherapy | ADXS11-001 (1 x 109 CFU) every 4 wk x 3 doses (wk 1, 4 and 7), then every 8 wk x 5 doses (wk 15, 23, 31, 39 and 46) | 450 | Jun-21 | Pending | Pending | |
| Cervix or head and neck | I/II | Cohen EEW (37) NCT022 91055 |
Persistent/recurrent metastatic | ADXS11-001 ± Durvalumab | Phase I: ADXS11-001 at 1 × 109 doses + Durvalumab 3 mg/kg (3 + 3 design for the staggered dose) Phase II: ADXS11-001 at 1 × 109 CFU doses + Durvalumab 10 mg/kg |
66 | Dec-19 | Pending | Pending |
CFU: colony forming units; CR: complete response; PR: partial response; SD: stable disease; PD: progressive disease; RR: response rates; DLT: dose limiting toxicity; AEs: adverse events; TrAEs: treatment-related adverse events; OS: overall survival; PFS: progression-free survival; wk: week; m: months.