- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02122861
Phase 1 Study of Intradermal LV305 in Patients With Locally Advanced, Relapsed or Metastatic Cancer Expressing NY-ESO-1
March 4, 2019 updated by: Immune Design
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
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.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
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 Type
Interventional
Enrollment (Actual)
47
Phase
- Phase 1
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
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California
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San Francisco, California, United States, 94115
- San Francisco Oncology Associates
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Connecticut
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New Haven, Connecticut, United States, 06520
- Yale University
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Massachusetts
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Boston, Massachusetts, United States, 02215
- Dana Farber Harvard Cancer Center
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Minnesota
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Rochester, Minnesota, United States, 55905
- Mayo Clinic
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South Carolina
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Greenville, South Carolina, United States, 29605
- Greenville Health System
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Texas
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Houston, Texas, United States, 77030
- MD Anderson Cancer Center
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Washington
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Seattle, Washington, United States, 98102
- Seattle Cancer Care Alliance
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-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years to 100 years (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
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 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.
Exclusion Criteria:
- 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.
- 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.
Brain metastases considered unstable as:
- Without confirmed stability over 60 days in patients previously treated with prior surgery or radiation; OR
- Associated with symptoms and/or findings; OR
- Requiring corticosteroids or anticonvulsants in the prior 60 days
- If enrolled in Part 2SA, new, growing, or previously untreated lesions since the start of anti-PD-1 therapy.
- Pregnant, planning to become pregnant, or nursing
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: ID-LV305
Dose escalation and expansion cohort including treatment of melanoma
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pembrolizumab
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Safety and tolerability
Time Frame: Up to 5 years after first study vaccine injection.
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Incidence of Treatment-Emergent Adverse Events [Safety and Tolerability].
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Up to 5 years after first study vaccine injection.
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Immunogenicity
Time Frame: Approximately 12 weeks
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Measure changes from baseline in anti-NY-ESO-1 serum antibodies and anti-LV antibodies and changes from baseline in peripheral blood of NY-ESO-1 specific CD4+, CD8+, Teff and Treg cells.
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Approximately 12 weeks
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Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Collaborators
Investigators
- Study Director: Clinical Trials, Immune Design
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
May 30, 2014
Primary Completion (Actual)
November 14, 2018
Study Completion (Actual)
December 15, 2018
Study Registration Dates
First Submitted
April 22, 2014
First Submitted That Met QC Criteria
April 24, 2014
First Posted (Estimate)
April 25, 2014
Study Record Updates
Last Update Posted (Actual)
March 6, 2019
Last Update Submitted That Met QC Criteria
March 4, 2019
Last Verified
March 1, 2019
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- ID-LV305-2013-001
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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