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ID-LV305

Phase 1

Melanoma - Currently Enrolling | Monoclonal antibody | Oncology |Merck & Company, Inc.|Last Updated: Mar 6, 2019

Success Probability

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Market & Valuation

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Trial Design

UNCONTROLLEDDMCBiomarker
Total Trials1
Total Enrollment47

FDA Designations

No designations recorded

Clinical trial landscape

ID-LV305 · 1 trial · 3 indications

Phase 1 1
NCT02122861Phase 1 Study of Intradermal LV305 in Patients With Locally Advanced, Relapsed or Metastatic Cancer Expressing NY-ESO-1Melanoma - Currently Enrolling
COMPLETED47 Analytics
PHASE1COMPLETED
Phase 1 Study of Intradermal LV305 in Patients With Locally Advanced, Relapsed or Metastatic Cancer Expressing NY-ESO-1
Melanoma - Currently EnrollingUnlock trial analytics

Study Endpoints

Primary Endpoints

Safety and tolerability
Up to 5 years after first study vaccine injection.

Incidence of Treatment-Emergent Adverse Events \[Safety and Tolerability\].

Secondary Endpoints

Immunogenicity
Approximately 12 weeks
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Study Design & Arms

AllocationNA
MaskingNONE
ModelSINGLE_GROUP
PurposeTREATMENT

Treatment Arms

ArmTypeDescription
ID-LV305EXPERIMENTALDose escalation and expansion cohort including treatment of melanoma

Interventions

NameTypeDescription
ID-LV305BIOLOGICALpembrolizumab
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Eligibility Criteria

Age Range18 Years to 100 Years
SexALL
Healthy VolunteersNo
Study Sites7

Inclusion Criteria: * Locally advanced, relapsed, and/or metastatic cancer with low or minimal tumor burden which may or may not be measurable; no tumor size criteria are used. * Tumor histology consistent with melanoma tumor specimen positive for NY-ESO-1 expression by IHC and/or RT-PCR. * b. In P...

Countries:United States
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Frequently asked questions about ID-LV305

What is ID-LV305 used for in melanoma?

ID-LV305 is an investigational monoclonal antibody being studied for use in melanoma. It is currently enrolling patients with locally advanced, relapsed or metastatic cancer that expresses NY-ESO-1, including melanoma. The drug is in Phase 1 clinical development and is not yet approved by the FDA.

What does ID-LV305 target?

ID-LV305 targets NY-ESO-1, a tumor antigen expressed in certain cancers. The drug is designed to treat cancers that express this antigen, including melanoma, non-small cell lung cancer, and sarcoma. It is being studied in a Phase 1 clinical trial for its safety and efficacy.

Who makes ID-LV305?

ID-LV305 is being developed by Merck & Company, Inc., a pharmaceutical company traded on the New York Stock Exchange under the ticker symbol MRK. The drug is currently in Phase 1 clinical development for the treatment of cancers expressing NY-ESO-1.

What phase is ID-LV305 in?

ID-LV305 is in Phase 1 clinical development. It is an investigational drug and has not been approved by the FDA. The drug is being studied in a completed Phase 1 trial for patients with locally advanced, relapsed or metastatic cancer expressing NY-ESO-1.

What clinical trials is ID-LV305 in?

ID-LV305 has one completed clinical trial, NCT02122861, a Phase 1 study of intradermal LV305 in patients with locally advanced, relapsed or metastatic cancer expressing NY-ESO-1. The trial enrolled 47 participants in the United States and included patients with melanoma, non-small cell lung cancer, and sarcoma.

Is ID-LV305 the same as LV305?

Yes, ID-LV305 is also known as LV305. The clinical trial NCT02122861 refers to the drug as LV305, and it is being developed by Merck & Company, Inc. for the treatment of cancers expressing NY-ESO-1.