Phase 1 Study of Intradermal LV305 in Patients With Locally Advanced, Relapsed or Metastatic Cancer Expressing NY-ESO-1

NCT02122861 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 47

Last updated 2019-03-06

No results posted yet for this study

Summary

This is a Phase 1 multi-center study to evaluate the clinical safety and immune response of ID-LV305 when injected intradermally in patients with advanced cancer. ID-LV305 is a novel immunotherapy agent designed to target dendritic cells and stimulate the body's immune system to fight the spread and growth of cancer for patients whose tumors express the NY-ESO-1 protein. Patients with melanoma, sarcoma, ovarian cancer, or small cell lung cancer that express NY-ESO-1 may be considered for the trial. Selected sites will be evaluating ID-LV305 with pembrolizumab for patients with melanoma who have inadequately responded to anti-PD-1 therapy.

Conditions

  • Melanoma - Currently Enrolling
  • Non-small Cell Lung Cancer - Enrollment Completed
  • Sarcoma - Enrollment Completed

Interventions

BIOLOGICAL

ID-LV305

pembrolizumab

Sponsors & Collaborators

  • Merck Sharp & Dohme LLC

    collaborator INDUSTRY
  • Immune Design, a subsidiary of Merck & Co., Inc. (Rahway, New Jersey USA)

    lead INDUSTRY

Principal Investigators

  • Clinical Trials · Immune Design, a subsidiary of Merck & Co., Inc. (Rahway, New Jersey USA)

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Max Age
100 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2014-05-30
Primary Completion
2018-11-14
Completion
2018-12-15

Countries

  • United States

Study Locations

More Related Trials

Entities

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02122861 on ClinicalTrials.gov