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

NCT02122861 | Completed Phase 1 DMC

• 1 other identifier: ID-LV305-2013-001
• Study Type: interventional
• Target: 47
• Locations: 1 country
• Sites: 7

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.

Conditions

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

Keywords

Melanoma

Outcome Measures

Primary Outcomes (1)

• Safety and tolerability

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

  Up to 5 years after first study vaccine injection.

Secondary Outcomes (1)

• Immunogenicity

  Approximately 12 weeks

Study Arms (1)

ID-LV305

EXPERIMENTAL

Dose escalation and expansion cohort including treatment of melanoma

Biological: ID-LV305

Interventions

ID-LV305 BIOLOGICAL

pembrolizumab

ID-LV305

Eligibility Criteria

• Age: 18 Years - 100 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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 Part 2SA, patients with an inadequate response to anti-PD-1 mAb therapy, defined as SD or PD using RECIST v1.1 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 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) or ECOG status. No tumor size criteria are used in Part 2SA.
• ≥ 18 years of age.
• Life expectancy of ≥ 6 months per the investigator.
• Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1.
• ECG without evidence of clinically significant arrhythmia or ischemia.
• If female of childbearing potential (FCBP), willing to undergo pregnancy testing and agrees to use at least one highly effective or two effective contraceptive methods during the dosing period and for three months after last LV305 injection. If enrolled on the arm that includes pembrolizumab, agrees to use highly effective contraceptive methods during the dosing period and for 120 days after last injection of study drug.
• If male and sexually active with a FCBP, must agree to use highly effective contraception such as latex condom during the dosing period and for three months after last LV305 injection. If enrolled on the arm that includes pembrolizumab, agrees to use highly effective contraceptive methods during the dosing period and for 120 days after last injection of study drug.

You may not qualify if:

• Investigational therapy within 3 weeks prior to LV305 dosing.
• Prior administration of other NY-ESO-1-targeting immunotherapeutics.
• Significant immunosuppression from:
• Concurrent, recent (≤ 4 weeks ago) or anticipated treatment with systemic corticosteroids at any dose, or
• Other immunosuppressive medications such as methotrexate, cyclosporine, azathioprine (antihistamines, non-steroidal anti- inflammatory drugs and aspirin permitted) or conditions such as common variable hypogammaglobulinemia or exposures such as large field radiotherapy
• Cancer therapies, including chemotherapy, radiation, biologics or kinase inhibitors, G-CSF or GM-CSF within 3 weeks prior to the first scheduled LV305 dosing. For patients enrolled in Part 2, Site-specific Amendment, erythropoietin, G-CSF, and GM-CSF will be allowed and anti-PD-1 therapy may be given within 3 weeks if it follows their prior treatment schedule.
• Psychiatric, other medical illness or other condition that in the opinion of the PI prevents compliance with study procedures or ability to provide valid informed consent.
• Significant autoimmune disease with the exception of alopecia, vitiligo, hypothyroidism or other conditions that have never been clinically active or were transient and have completely resolved and require no ongoing therapy. For patients enrolled in Part 2SA who have the potential to receive pembrolizumab, active autoimmune disease that has required systemic treatment in the past 2 years (i.e., with use of disease modifying agents, corticosteroids or immunosuppressive drugs). Replacement therapy (e.g., thyroxine, insulin, etc.) is not considered a form of systemic treatment.
• Myocardial infarction within 6 months of study initiation, active cardiac ischemia or New York Heart Association (NYHA) Grade III or IV heart failure.
• Inadequate organ function including:
• Marrow: Peripheral blood leukocyte count (WBC) \< 3000/mm3, absolute neutrophils count ≤ 1500/mm3, platelets \< 75000/mm3, or hemoglobin \< 10 gm/dL.
• Hepatic: alanine aminotransferase (ALT), and aspartate aminotransferase (AST) \> 2.5 x ULN, total serum bilirubin \> 1.5 x ULN (patients with Gilbert's Disease may be included if their total bilirubin is ≤ 3.0 mg/dL).
• Renal: Creatinine \> 1.5x ULN.
• Other: INR (prothrombin time ratio) or partial thromboplastin time (PTT) \>1.5 x ULN.
• For patients enrolled in Part 2SA who are receiving anti-PD-1 mAb therapy, marrow and hepatic function as defined in criteria 8a and 8b may be up to CTCAE Grade 2 if first reviewed, found to be within acceptable safety parameters for treatment with pembrolizumab, and approved by the Sponsor Medical Monitor.

Sponsors & Collaborators

• Immune Design, a subsidiary of Merck & Co., Inc. (Rahway, New Jersey USA): lead
• Merck Sharp & Dohme LLC: collaborator

Study Sites (7)

San Francisco Oncology Associates

San Francisco, California, 94115, United States

Location

Yale University

New Haven, Connecticut, 06520, United States

Location

Dana Farber Harvard Cancer Center

Boston, Massachusetts, 02215, United States

Location

Mayo Clinic

Rochester, Minnesota, 55905, United States

Location

Greenville Health System

Greenville, South Carolina, 29605, United States

Location

MD Anderson Cancer Center

Houston, Texas, 77030, United States

Location

Seattle Cancer Care Alliance

Seattle, Washington, 98102, United States

Location

MeSH Terms

Conditions

Melanoma

Condition Hierarchy (Ancestors)

Neuroendocrine Tumors; Neuroectodermal Tumors; Neoplasms, Germ Cell and Embryonal; Neoplasms by Histologic Type; Neoplasms; Neoplasms, Nerve Tissue; Nevi and Melanomas; Skin Neoplasms; Neoplasms by Site; Skin Diseases; Skin and Connective Tissue Diseases

Study Officials

• Clinical Trials

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

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 22, 2014
• First Posted: April 25, 2014
• Study Start: May 30, 2014
• Primary Completion: November 14, 2018
• Study Completion: December 15, 2018
• Last Updated: March 6, 2019

Record last verified: 2019-03

Locations

US (7)