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 |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT03721978 | REVEAL 2 Trial (Evaluation of VGX-3100 and Electroporation for the Treatment of Cervical HSIL) | PHASE3 | COMPLETED | 203 | — | — | Feb 28, 2019 | Sep 15, 2022 | Oct 17, 2024 | 53 | United States, Argentina +8 |
| NCT03185013 | REVEAL 1 (Evaluation of VGX-3100 and Electroporation for the Treatment of Cervical HSIL) | PHASE3 | COMPLETED | 201 | — | — | Jun 28, 2017 | Apr 6, 2021 | Jul 27, 2023 | 60 | United States, Argentina +17 |
Baseline biomarker-positive participants with no histologic (i.e., biopsies or excisional treatment) evidence of cervical HSIL, no evidence of HPV-16 and/or HPV-18 at Week 36, and participants who did not have unscheduled excision or biopsy sample obtained between the initial dose up to Week 36 were considered to be responders. No evidence of HSIL was defined by histology as negative, squamous atypia, or low-grade intraepithelial lesion (LSIL). Cervical samples for HPV-16 and/or HPV-18 were collected using the ThinPrep™. The efficacy time frame is defined by a biopsy or surgical excision at any time starting from 14 days prior to the protocol-specified target date of Week 36. The first tissue removal sample within the time frame determines the histology endpoint.
Participants with no histologic (i.e., biopsies or excisional treatment) evidence of cervical HSIL, no evidence of HPV-16 and/or HPV-18 at the Week 36 time frame, and participants in which excision or biopsy sample was not obtained between the initial dose up to Week 36 were considered to be responders. No evidence of HSIL was defined by histology as negative, squamous atypia, or low-grade intraepithelial lesion (LSIL). Cervical samples for HPV-16 and/or HPV-18 were collected using the ThinPrep®.
| Arm | Type | Description |
|---|---|---|
| VGX-3100 + EP | EXPERIMENTAL | Participants received 3 IM injections of 6 mg (in 1 mL) VGX-3100 followed by EP using the CELLECTRA™-5PSP device on Day 0, Week 4, and Week 12. |
| Matched Placebo + EP | PLACEBO_COMPARATOR | Participants received 3 IM injections of 1 mL VGX-3100 matching placebo followed by EP using the CELLECTRA™-5PSP device on Day 0, Week 4, and Week 12. |
| Placebo + EP | PLACEBO_COMPARATOR | Participants received three IM injections of 1 mL VGX-3100 matching placebo followed by EP using the CELLECTRA™-5PSP device on Day 0, Week 4, and Week 12. |
| Name | Type | Description |
|---|---|---|
| VGX-3100 | BIOLOGICAL | 1 milliliter (mL) VGX-3100 injected IM. |
| Matched Placebo | BIOLOGICAL | 1 mL of matched Placebo injected IM. |
| CELLECTRA™-5PSP | DEVICE | CELLECTRA™-5PSP used for EP following IM injection of VGX 3100. |
| Placebo | BIOLOGICAL | 1 mL of Placebo will be injected IM and delivered by EP using CELLECTRA™-5PSP on Day 0, Week 4 and Week 12. |
| Electroporation (EP) | DEVICE | Intramuscular injection followed by EP with the CELLECTRA™ 5PSP device. |
Inclusion Criteria: * Women aged 18 years and above * Confirmed cervical infection with HPV types 16 and/or 18 at screening * Cervical tissue specimen/slides provided to Study Pathology Adjudication Committee for diagnosis scheduled to be collected within 10 weeks prior to anticipated date of first...