Ignite Creation Date:
2025-12-24 @ 12:34 PM
Ignite Modification Date:
2025-12-24 @ 12:34 PM
Study NCT ID:
NCT02122861
Status:
COMPLETED
Last Update Posted:
2019-03-06
First Post:
2014-04-22
Is Possible Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Phase 1 Study of Intradermal LV305 in Patients With Locally Advanced, Relapsed or Metastatic Cancer Expressing NY-ESO-1
Sponsor:
Immune Design, a subsidiary of Merck & Co., Inc. (Rahway, New Jersey USA)
Organization:
Study Overview
Official Title:
A Phase 1, Open-Label Clinical Trial Evaluating the Safety, Tolerability and Immunogenicity of Intradermally Administered ID-LV305 in Patients With Locally Advanced, Relapsed, or Metastatic Cancer Expressing NY-ESO-1
Status:
COMPLETED
Status Verified Date:
2019-03
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief 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.
Detailed Description:
ID-LV305 is an agent designed to specifically target dendritic cells within the patient and induce them to stimulate and generate cytotoxic T cell responses against the NY-ESO-1 protein, a molecule which is often expressed in certain types of cancer cells. This is a first in human study of ID-LV305. The primary purpose of the study is to determine what dose ID-LV305 can be given safely to patients with advanced cancers that express NY-ESO-1 protein. ID-LV305 will be administered by intradermal injection every three weeks times four doses. The study will have two phases. In Part 1, Dose Escalation, which has been completed, three sequentially enrolled cohorts of patients were treated at one of four dose levels of ID-LV305 using a standard escalation design. Followed by Part 2 expansion where an additional 27 subjects were enrolled. In Part 2SA, Site-specific Amendment, patients with unresectable and/or metastatic melanoma with an inadequate response to anti-PD-1 MAb therapy, defined as SD or PD using RECIST criteria following at least 2 months of therapy. Patients with PD have a tumor measurement increase of \<2-fold from the time of starting anti-PD-1 therapy, must not be symptomatic or have worsening of Eastern Cooperative Oncology Group (ECOG) performance status due to their disease progression, and cannot have new CNS lesion. Patients must also meet the lactic acid dehydrogenase (LDH), ECOG status, and no tumor size criteria are used in Part 2SA.
Study Oversight
Has Oversight DMC:
True
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: