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 |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT04291105 | Phase 2 Trial of Voyager V1 in Combination With Cemiplimab in Cancer Patients | PHASE2 | RECRUITING | 87 | — | — | Apr 24, 2020 | Dec 1, 2025 | Mar 26, 2025 | 27 | United States, Brazil |
Percentage of participants with objective response is assessed every six weeks from Cycle 1 Day 1 through disease progression, by investigator review based on RECIST version 1.1
| Arm | Type | Description |
|---|---|---|
| Melanoma intratumoral | EXPERIMENTAL | Melanoma, IT VV1 + IV cemiplimab Patients will receive both treatments on Day 1 and every 3 weeks thereafter until lack of clinical benefit or limiting toxicity. VV1 or cemiplimab can continue after the first dose in combination or as a single agent treatment in subsequent doses. |
| Head and Neck SCC intratumoral | EXPERIMENTAL | HNSCC, IT VV1 + IV cemiplimab, Patients will receive both treatments on Day 1 and every 3 weeks thereafter until lack of clinical benefit or limiting toxicity. VV1 or cemiplimab can continue after the first dose in combination or as a single agent treatment in subsequent doses. |
| Colo-rectal Carcinoma intratumoral (Arm closed) | EXPERIMENTAL | (CLOSED) IT VV1 + IV cemiplimab, Patients will receive both treatments on Day 1 and every 3 weeks thereafter until lack of clinical benefit or limiting toxicity. VV1 or cemiplimab can continue after the first dose in combination or as a single agent treatment in subsequent doses. |
| Name | Type | Description |
|---|---|---|
| VV1 | BIOLOGICAL | VV1 is to be administered on Day 1 and every 3 weeks as long as there is clinical benefit |
| Cemiplimab | BIOLOGICAL | Cemiplimab should be given on Day 8 of Cycle 1 (28 days) and then Day 1 of each subsequent 21-day cycle. |
Inclusion: 1. Age ≥18 years on day of signing informed consent. 2. Specific by tumor cohorts: a. For the HSNCC cohort, histologically confirmed diagnosis of advanced and/or metastatic HSNCC suitable for first line immunotherapy. i. HPV+ and HPV- patients are allowed. ii. Primary tumor l...