Phase 1 Study of Intradermal LV305 in Patients With Locally Advanced, Relapsed or Metastatic Cancer Expressing NY-ESO-1
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT02122861|
Recruitment Status : Completed
First Posted : April 25, 2014
Last Update Posted : March 6, 2019
- Study Details
- Tabular View
- No Results Posted
- How to Read a Study Record
|Condition or disease||Intervention/treatment||Phase|
|Melanoma - Currently Enrolling Non-small Cell Lung Cancer - Enrollment Completed Sarcoma - Enrollment Completed||Biological: ID-LV305||Phase 1|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||47 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|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|
|Actual Study Start Date :||May 30, 2014|
|Actual Primary Completion Date :||November 14, 2018|
|Actual Study Completion Date :||December 15, 2018|
Dose escalation and expansion cohort including treatment of melanoma
- Safety and tolerability [ Time Frame: Up to 5 years after first study vaccine injection. ]Incidence of Treatment-Emergent Adverse Events [Safety and Tolerability].
- Immunogenicity [ Time Frame: Approximately 12 weeks ]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.
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, Learn About Clinical Studies.
|Ages Eligible for Study:||18 Years to 100 Years (Adult, Older Adult)|
|Sexes Eligible for Study:||All|
|Accepts Healthy Volunteers:||No|
- 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.
- 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
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02122861
|United States, California|
|San Francisco Oncology Associates|
|San Francisco, California, United States, 94115|
|United States, Connecticut|
|New Haven, Connecticut, United States, 06520|
|United States, Massachusetts|
|Dana Farber Harvard Cancer Center|
|Boston, Massachusetts, United States, 02215|
|United States, Minnesota|
|Rochester, Minnesota, United States, 55905|
|United States, South Carolina|
|Greenville Health System|
|Greenville, South Carolina, United States, 29605|
|United States, Texas|
|MD Anderson Cancer Center|
|Houston, Texas, United States, 77030|
|United States, Washington|
|Seattle Cancer Care Alliance|
|Seattle, Washington, United States, 98102|
|Study Director:||Clinical Trials||Immune Design|
|Responsible Party:||Immune Design|
|Other Study ID Numbers:||
|First Posted:||April 25, 2014 Key Record Dates|
|Last Update Posted:||March 6, 2019|
|Last Verified:||March 2019|
Neoplasms, Germ Cell and Embryonal
Neoplasms by Histologic Type
Neoplasms, Nerve Tissue
Nevi and Melanomas