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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VV1 is an investigational monoclonal antibody being studied for the treatment of melanoma. It is currently in Phase 2 clinical development for this indication. VV1 is being evaluated in combination with cemiplimab in cancer patients, including those with melanoma.
VV1 is a monoclonal antibody, but its specific molecular target has not been disclosed in available information. The drug is being studied in oncology, specifically in combination with cemiplimab for the treatment of melanoma and other solid tumors.
VV1 is being developed by Regeneron Pharmaceuticals, Inc., a biopharmaceutical company traded on NASDAQ under the ticker REGN. The company is conducting a Phase 2 clinical trial of VV1 in combination with cemiplimab for cancer patients.
VV1 is currently in Phase 2 clinical development. It is an investigational drug and has not been approved by regulatory authorities. The ongoing Phase 2 trial is active but not recruiting participants.
VV1 is being studied in a Phase 2 clinical trial with the identifier NCT04291105. This trial evaluates VV1 in combination with cemiplimab in patients with melanoma, head and neck squamous cell carcinoma, and colorectal cancer. The trial is being conducted in the United States and Brazil.
VV1 is also referred to as Voyager V1 in clinical trial documentation. The Phase 2 trial NCT04291105 is titled 'Phase 2 Trial of Voyager V1 in Combination With Cemiplimab in Cancer Patients,' confirming that VV1 and Voyager V1 refer to the same investigational drug.