Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
VV1 · 1 trial · 3 indications
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 | (CLOSED): 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...
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