Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
TLPLDC Vaccine · 1 trial · 1 indication
Safety of adding the TLPLDC vaccine to SoC CPI monotherapy
Safety of adding the TLPLDC vaccine to SoC CPI monotherapy
| Arm | Type | Description |
|---|---|---|
| No clinical response | ACTIVE_COMPARATOR | No clinical response (PD de novo) after a minimum of 3 months on CPI monotherapy |
| Develop PD | ACTIVE_COMPARATOR | Develop PD after initial clinical response to CPI monotherapy |
| Stable Disease | ACTIVE_COMPARATOR | Stable disease for at least 6 months on CPI monotherapy |
| Name | Type | Description |
|---|---|---|
| TLPLDC Vaccine | DRUG | Tumor Lysate, Particle Loaded, Dendritic Cell Vaccine |
Inclusion Criteria: * 18 years or older * Eastern Cooperative Oncology Group (ECOG) performance status 0 or 1 (Appendix A) * Metastatic melanoma eligible for {or currently on} standard of care CPI therapy (treating physician's choice) with measurable disease. * Approximately 1 cm3 preferred but 1 m...
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TLPLDC Vaccine is an investigational autologous tumor lysate vaccine being studied for the treatment of metastatic melanoma. It is designed to be used in addition to standard of care checkpoint inhibitor therapy in patients with measurable disease. The vaccine is currently in clinical development and has not been approved by the FDA.
TLPLDC Vaccine is being developed by cbdMD, Inc., which trades under the ticker symbol YCBD. The company is conducting clinical research on this investigational vaccine for metastatic melanoma. As of the latest data, the vaccine is in Phase 1 clinical development.
TLPLDC Vaccine is in Phase 1 clinical development. It has completed one clinical trial, which was a Phase I/IIa study. The vaccine is investigational and has not received FDA approval. It is being studied for use in combination with standard of care checkpoint inhibitors for metastatic melanoma.
TLPLDC Vaccine has been studied in one completed clinical trial with the identifier NCT02678741. This was a multi-center Phase I/IIa trial evaluating the vaccine in addition to standard of care checkpoint inhibitor therapy in metastatic melanoma patients with measurable disease. The trial enrolled 26 participants in the United States.
TLPLDC Vaccine is an autologous tumor lysate vaccine that combines a patient's own tumor lysate with yeast cell wall particles and dendritic cells. This approach is designed to stimulate the immune system to recognize and attack cancer cells. The vaccine is being studied as an addition to checkpoint inhibitor therapy for metastatic melanoma.