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

This study is currently recruiting participants. (see Contacts and Locations)
Verified March 2016 by Immune Design
Sponsor:
Collaborator:
Merck Sharp & Dohme Corp.
Information provided by (Responsible Party):
Immune Design
ClinicalTrials.gov Identifier:
NCT02122861
First received: April 22, 2014
Last updated: May 25, 2016
Last verified: March 2016
  Purpose
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.

Condition Intervention Phase
Melanoma - Currently Enrolling
Non-small Cell Lung Cancer - Enrollment Completed
Ovarian Candcer - Enrollment Completed
Sarcoma - Enrollment Completed
Biological: ID-LV305
Phase 1

Study Type: Interventional
Study Design: Endpoint Classification: Safety Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
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

Resource links provided by NLM:


Further study details as provided by Immune Design:

Primary Outcome Measures:
  • Safety and tolerability [ Time Frame: Up to 2 years after first study vaccine injection. ] [ Designated as safety issue: Yes ]
    To evaluate the safety and tolerability of multiple ascending doses of intradermally (i.d.) administered ID-LV305 by assessing the number of participants experiencing AEs.


Secondary Outcome Measures:
  • Immunogenicity [ Time Frame: Approximately 12 weeks ] [ Designated as safety issue: No ]
    To evaluate the cellular and humoral immunogenicity of multiple ascending doses of i.d. administered ID-LV305 by assessing the frequency of inducing or increasing responses in participants.


Estimated Enrollment: 59
Study Start Date: May 2014
Estimated Study Completion Date: December 2018
Estimated Primary Completion Date: December 2018 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: ID-LV305
Dose escalation and expansion cohort including treatment of melanoma
Biological: ID-LV305
pembrolizumab

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. In Part 2, 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 3 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 maximum tumor size criteria outlined in this inclusion/exclusion criterion and in Appendix A.
  Eligibility

Ages Eligible for Study:   18 Years to 80 Years   (Adult, Senior)
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Locally advanced, relapsed, and/or metastatic cancer with low or minimal tumor burden which may or may not be measurable.
  • Tumor histology consistent with melanoma tumor specimen positive for NY-ESO-1 expression by IHC and/or RT-PCR.
  • Inadequate response,relapse, and/or unacceptable toxicity with one or more prior systemic, surgical, or radiation cancer therapies. Inadequate response is defined as having persistent disease, or if no measurable disease, having a ≥50% likelihood of recurrence despite standard treatment per investigator assessment.
  • 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 3 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 maximum tumor size criteria outlined in this inclusion/exclusion criterion and in Appendix A.
  • ≥ 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 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.

Exclusion Criteria:

  • Investigational therapy within 3 weeks prior to LV305 dosing.
  • Prior administration of other NY-ESO-1-targeting immunotherapeutics.
  • Significant immunosuppression from:

    1. Concurrent, recent (≤ 4 weeks ago) or anticipated treatment with systemic corticosteroids at any dose, or
    2. 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 2 of the Site-specific Amendment with 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:

    1. Marrow: Peripheral blood leukocyte count (WBC) < 3000/mm3, absolute neutrophils count ≤ 1500/mm3, platelets < 75000/mm3, or hemoglobin < 10 gm/dL.
    2. 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).
    3. Renal: Creatinine > 1.5x ULN.
    4. Other: INR (prothrombin time ratio) or partial thromboplastin time (PTT) >1.5 x ULN. For patients enrolled in Part 2 of the Site-specific Amendment 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.
  • History of other cancer within 3 years (except non-melanoma cutaneous malignancies and cervical carcinoma in situ). For patients enrolled in Part 2 of the Site-specific Amendment, history of other cancer within 1 year (except non-melanoma cutaneous malignancies and cervical carcinoma in situ. Concurrent active cancers are not allowed).
  • Active tuberculosis or recent (< 2 week ago) clinically significant infection or evidence of active hepatitis B, hepatitis C or HIV infection.
  • Uveal melanoma or LDH >1.1 x ULN.
  • Brain metastases considered unstable as:

    1. Without confirmed stability over 60 days in patients previously treated with prior surgery or radiation; OR
    2. Associated with symptoms and/or findings; OR
    3. Requiring corticosteroids or anticonvulsants in the prior 60 days
    4. If enrolled in Part 2 of the Site-specific Amendment, new, growing, or previously untreated lesions since the start of anti-PD-1 therapy.
  • Pregnant, planning to become pregnant, or nursing
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT02122861

Contacts
Contact: Immune Design 650-392-8312 ClinicalTrials@immunedesign.com

Locations
United States, California
San Francisco Oncology Associates Recruiting
San Francisco, California, United States, 94115
Contact: Ron Frianeza    415-600-3027    FrianeR@cpmcri.org   
Contact: Peter Gasper    415-600-3472    peter@cpmcri.org   
Principal Investigator: Kevin Kim         
Sarcoma Oncology Center Recruiting
Santa Monica, California, United States, 91406
Contact: Victoria Chua    310-552-9999    vchua@sarcomaoncology.com   
United States, Connecticut
Yale University Recruiting
New Haven, Connecticut, United States, 06520
Contact: Danielle Wanik    203-767-1889    Danielle.wanik@yale.edu   
United States, Massachusetts
Dana Farber Harvard Cancer Center Recruiting
Boston, Massachusetts, United States, 02215
Contact: Kara Stefaniak    617-632-5617    Kara_stefaniak@dfci.harvard.edu   
United States, Minnesota
Mayo Clinic Recruiting
Rochester, Minnesota, United States, 55905
Contact: Clinical Trials Referrals Office    855-776-0015      
United States, New Jersey
Atlantic Health System Recruiting
Morristown, New Jersey, United States, 07960
Contact: Maureen Nowakowski    973-971-5569    Maureen.Nowakowski@atlantichealth.org   
Contact: Barbara Peloquin    973-971-6298      
Principal Investigator: Eric Whitman         
United States, South Carolina
Greenville Health System Recruiting
Greenville, South Carolina, United States, 29605
Contact: Lisa Johnson    864-455-3735    mailto:ljohnson4@ghs.org   
Contact: Jill Cantrell    864-455-3737    jcantrell@ghs.org   
United States, Texas
MD Anderson Cancer Center Active, not recruiting
Houston, Texas, United States, 77030
United States, Washington
Seattle Cancer Care Alliance Active, not recruiting
Seattle, Washington, United States, 98102
Sponsors and Collaborators
Immune Design
Merck Sharp & Dohme Corp.
Investigators
Study Director: Clinical Trials Immune Design
  More Information

Responsible Party: Immune Design
ClinicalTrials.gov Identifier: NCT02122861     History of Changes
Other Study ID Numbers: ID-LV305-2013-001 
Study First Received: April 22, 2014
Last Updated: May 25, 2016
Health Authority: United States: Food and Drug Administration

Keywords provided by Immune Design:
Melanoma

Additional relevant MeSH terms:
Carcinoma, Non-Small-Cell Lung
Melanoma
Neoplasm Metastasis
Carcinoma, Bronchogenic
Bronchial Neoplasms
Lung Neoplasms
Respiratory Tract Neoplasms
Thoracic Neoplasms
Neoplasms by Site
Neoplasms
Lung Diseases
Respiratory Tract Diseases
Neuroendocrine Tumors
Neuroectodermal Tumors
Neoplasms, Germ Cell and Embryonal
Neoplasms by Histologic Type
Neoplasms, Nerve Tissue
Nevi and Melanomas
Neoplastic Processes
Pathologic Processes

ClinicalTrials.gov processed this record on December 02, 2016