Expanded Access Protocol of Talimogene Laherparepvec for Subjects With Unresected, Stage lllB to IVM1c Melanoma
A Phase 3b, Multicenter, Open-label, Single-arm, Expanded Access Protocol of Talimogene Laherparepvec for the Treatment of Subjects With Unresected, Stage lllB to IVM1c Melanoma
1 other identifier
expanded_access
N/A
1 country
24
Brief Summary
Expanded access of Talimogene Laherparepvec for subjects with unresected, stage IIIb to IVM1c Melanoma.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
24 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
May 1, 2014
CompletedFirst Posted
Study publicly available on registry
May 28, 2014
CompletedMarch 1, 2016
February 1, 2016
May 1, 2014
February 26, 2016
Conditions
Keywords
Interventions
Up to 4ml of talimogene laherparepvec per cycle visit
Eligibility Criteria
You may qualify if:
- Histologically confirmed diagnosis of melanoma
- Subject has unresected stage lllB to IVM1c melanoma regardless of prior therapy
- Subject who is not eligible for or cannot access ongoing talimogene laherparepvec clinical trials
- Candidate for intralesional therapy (ie, disease is appropriate for direct injection or through the use of ultrasound guidance) defined as one of the following:
- for a subject not previously treated with talimogene laherparepvec:
- at least 1 injectable cutaneous, subcutaneous, or nodal melanoma lesion ≥ 10 mm in longest diameter, or
- multiple injectable melanoma lesions that in aggregate have a longest diameter of ≥ 10 mm
- for a subject previously treated with talimogene laherparepvec:
- at least 1 injectable cutaneous, subcutaneous, or nodal melanoma lesion must be present (no minimal size criteria)
- Eastern Cooperative Oncology Group (ECOG) performance status of 0, 1, or 2
- Adequate organ function determined within 35 days prior to enrollment
- Serum LDH levels less than or equal to 1.5 ULN within 35 days prior to enrollment
- For a subject who previously received talimogene laherparepvec in another clinical trial, subject must have ended treatment for reason(s) other than disease progression or intolerability to talimogene laherparepvec
You may not qualify if:
- Clinically active cerebral metastases. Subjects with up to 3 (neurological performance status of 0) cerebral metastases may be enrolled, provided that all lesions have been adequately treated with stereotactic radiation therapy, craniotomy, gammaknife therapy, with no evidence of progression, and have not required steroids, for at least two (2) months prior to enrollment.
- Greater than 3 visceral metastases (this does not include lung metastases or nodal metastases associated with visceral organs). For subjects with less than or equal to 3 visceral metastases, no lesion \> 3 cm, and liver lesions must meet RECIST criteria for stable disease for at least 1 month prior to enrollment.
- Bone metastases
- Primary ocular or mucosal melanoma
- History or evidence of symptomatic autoimmune pneumonitis, glomerulonephritis, vasculitis, or other symptomatic autoimmune disease
- Evidence of clinically significant immunosuppression
- Active herpetic skin lesions or prior complications of HSV-1 infection (eg, herpetic keratitis or encephalitis)
- Requires intermittent or chronic systemic (intravenous or oral) treatment with an antiherpetic drug (eg, acyclovir), other than intermittent topical use
- Currently receiving treatment with another investigational device or drug study besides talimogene laherparepvec, or less than 28 days since ending treatment with another investigational device or drug study(s)
- Other investigational procedures while participating in this protocol are excluded
- Known to have acute or chronic active hepatitis B or hepatitis C infection
- Known to have human immunodeficiency virus infection
- History of other malignancy within the past 3 years with the following exceptions:
- malignancy treated with curative intent and with no known active disease present for ≥ 3 years before enrollment and felt to be at low risk for recurrence by the treating physician
- adequately treated non-melanoma skin cancer or lentigo maligna without evidence of disease
- +8 more criteria
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Amgenlead
Study Sites (24)
Research Site
Mobile, Alabama, 36604, United States
Research Site
Mobile, Alabama, 36608, United States
Research Site
Little Rock, Arkansas, 72205, United States
Research Site
Duarte, California, 91010, United States
Research Site
La Jolla, California, 92093-0698, United States
Research Site
Daytona Beach, Florida, 32117, United States
Research Site
Jacksonville, Florida, 32207, United States
Research Site
Miami Beach, Florida, 33140, United States
Research Site
Indianapolis, Indiana, 46260, United States
Research Site
Louisville, Kentucky, 40202, United States
Research Site
Minneapolis, Minnesota, 55407, United States
Research Site
St Louis, Missouri, 63110-1093, United States
Research Site
Omaha, Nebraska, 68130, United States
Research Site
Omaha, Nebraska, 68198, United States
Research Site
Morristown, New Jersey, 07962, United States
Research Site
New York, New York, 10016, United States
Research Site
Winston-Salem, North Carolina, 27157, United States
Research Site
Canton, Ohio, 44718, United States
Research Site
Portland, Oregon, 97213, United States
Research Site
Greenville, South Carolina, 29605, United States
Research Site
Dallas, Texas, 75230, United States
Research Site
Dallas, Texas, 75390, United States
Research Site
Franklin, Wisconsin, 53132, United States
Research Site
Wauwatosa, Wisconsin, 53226, United States
Related Publications (1)
Chesney J, Imbert-Fernandez Y, Telang S, Baum M, Ranjan S, Fraig M, Batty N. Potential clinical and immunotherapeutic utility of talimogene laherparepvec for patients with melanoma after disease progression on immune checkpoint inhibitors and BRAF inhibitors. Melanoma Res. 2018 Jun;28(3):250-255. doi: 10.1097/CMR.0000000000000444.
PMID: 29561296DERIVED
Related Links
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
MD
Amgen
Study Design
- Study Type
- expanded access
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
May 1, 2014
First Posted
May 28, 2014
Last Updated
March 1, 2016
Record last verified: 2016-02