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TLPLDC Vaccine

Phase 1

Metastatic Melanoma | Small molecule | Oncology |cbdMD, Inc.|Last Updated: Mar 12, 2024

Success Probability

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Market & Valuation

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Trial Design

ACTIVE_CONTROLLEDDMCBiomarker
Total Trials1
Total Enrollment26

FDA Designations

No designations recorded

Clinical trial landscape

TLPLDC Vaccine · 1 trial · 1 indication

Phase 1 1
NCT02678741Multi-center Phase I/IIa Trial of an Autologous Tumor Lysate (TL) + Yeast Cell Wall Particles (YCWP) + Dendritic Cells (DC) Vaccine in Addition to Standard of Care Checkpoint Inhibitor of Choice in Metastatic Melanoma Patients With Measurable Disease.Metastatic Melanoma
COMPLETED26 Analytics
PHASE1COMPLETED
Multi-center Phase I/IIa Trial of an Autologous Tumor Lysate (TL) + Yeast Cell Wall Particles (YCWP) + Dendritic Cells (DC) Vaccine in Addition to Standard of Care Checkpoint Inhibitor of Choice in Metastatic Melanoma Patients With Measurable Disease.
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Study Endpoints

Primary Endpoints

Graded Standard Systemic Toxicities (Using CTCAE Graded Toxicity Scale) by Patient
12 months (1 year)

Safety of adding the TLPLDC vaccine to SoC CPI monotherapy

Graded Standard Systemic Toxicities (Using CTCAE Graded Toxicity Scale) by Number of AEs
12 months (1 year)

Safety of adding the TLPLDC vaccine to SoC CPI monotherapy

Secondary Endpoints

Tumor Response to Treatment Using Response Evaluation Criteria in Solid Tumors (RECIST) Criteria
12 months (1 year)
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Study Design & Arms

AllocationNON_RANDOMIZED
MaskingNONE
ModelPARALLEL
PurposeTREATMENT

Treatment Arms

ArmTypeDescription
No clinical responseACTIVE_COMPARATORNo clinical response (PD de novo) after a minimum of 3 months on CPI monotherapy
Develop PDACTIVE_COMPARATORDevelop PD after initial clinical response to CPI monotherapy
Stable DiseaseACTIVE_COMPARATORStable disease for at least 6 months on CPI monotherapy

Interventions

NameTypeDescription
TLPLDC VaccineDRUGTumor Lysate, Particle Loaded, Dendritic Cell Vaccine
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Eligibility Criteria

Age Range18 Years to N/A
SexALL
Healthy VolunteersNo
Study Sites7

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...

Countries:United States
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Frequently asked questions about TLPLDC Vaccine

What is TLPLDC Vaccine used for?

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.

Who makes TLPLDC Vaccine?

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.

What phase is TLPLDC Vaccine in?

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.

What clinical trials is TLPLDC Vaccine in?

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.

How does TLPLDC Vaccine work?

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.