Single-arm Trial to Evaluate the Role of the Immune Response to Talimogene Laherparepvec in Unresected Melanoma
NCT ID: NCT02366195
Last Updated: 2021-11-30
Study Results
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View full resultsBasic Information
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COMPLETED
PHASE2
112 participants
INTERVENTIONAL
2015-04-07
2020-12-25
Brief Summary
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Detailed Description
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Conditions
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Keywords
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Study Design
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NA
SINGLE_GROUP
TREATMENT
NONE
Study Groups
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Talimogene Laherparepvec
Talimogene laherparepvec was administered by intralesional injection into injectable cutaneous, subcutaneous, and nodal lesions at an initial dose of 10⁶ plaque-forming units (PFU) per mL on day 1 followed by a dose of 10⁸ PFU/mL 21 days after the initial dose and every 14 days thereafter. Participants were treated with talimogene laherparepvec until they achieved a complete response, all injectable tumors had disappeared, clinically significant (resulting in clinical deterioration or requiring change of therapy) disease progression beyond 6 months of treatment, per modified World Health Organization (WHO) response criteria, or intolerance of study treatment, whichever occurred first.
Talimogene Laherparepvec
The initial dose of talimogene laherparepvec is up to 4.0 mL of 10\^6 PFU/mL. Subsequent doses of talimogene laherparepvec are up to 4.0 mL of 10\^8 PFU/mL.
Interventions
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Talimogene Laherparepvec
The initial dose of talimogene laherparepvec is up to 4.0 mL of 10\^6 PFU/mL. Subsequent doses of talimogene laherparepvec are up to 4.0 mL of 10\^8 PFU/mL.
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
2. Subject with stage IIIB to IVM1c melanoma for whom surgery is not recommended
3. Candidate for intralesional therapy
4. Measurable disease with greatest diameter ≥ 10 mm
5. Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1
6. Adequate organ function
Exclusion Criteria
2. Bone metastases
3. Primary ocular or mucosal melanoma
4. Active herpetic skin lesions or prior complications of herpes simplex virus type 1 (HSV-1) infection (eg, herpetic keratitis or encephalitis)
5. Requires intermittent or chronic systemic (intravenous or oral) treatment with an antiherpetic drug (eg, acyclovir), other than intermittent topical use
6. Female subject is pregnant or breast-feeding, or planning to become pregnant during study treatment and through 3 months after the last dose of talimogene laherparepvec
7. Female subject of childbearing potential who is unwilling to use acceptable method(s) of effective contraception
18 Years
ALL
No
Sponsors
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Amgen
INDUSTRY
Responsible Party
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Principal Investigators
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MD
Role: STUDY_DIRECTOR
Amgen
Locations
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Research Site
Salt Lake City, Utah, United States
Research Site
Salzburg, , Austria
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Vienna, , Austria
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Brussels, , Belgium
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Brussels, , Belgium
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Liège, , Belgium
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Boulogne-Billancourt, , France
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Marseille, , France
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Nantes, , France
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Paris, , France
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Poitiers, , France
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Essen, , Germany
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Frankfurt am Main, , Germany
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Hanover, , Germany
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Heidelberg, , Germany
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Athens, , Greece
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Athens, , Greece
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Heraklion - Crete, , Greece
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Pátrai, , Greece
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Thessaloniki, , Greece
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Budapest, , Hungary
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Budapest, , Hungary
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Debrecen, , Hungary
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Pécs, , Hungary
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Szeged, , Hungary
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Bergamo, , Italy
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Milan, , Italy
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Siena, , Italy
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Amsterdam, , Netherlands
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Groningen, , Netherlands
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Konin, , Poland
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Warsaw, , Poland
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Moscow, , Russia
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Saint Petersburg, , Russia
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Donostia / San Sebastian, Basque Country, Spain
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Badalona, Catalonia, Spain
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Barcelona, Catalonia, Spain
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Valencia, Valencia, Spain
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Madrid, , Spain
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Madrid, , Spain
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London, , United Kingdom
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Metropolitan Borough of Wirral, , United Kingdom
Countries
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References
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Malvehy J, Samoylenko I, Schadendorf D, Gutzmer R, Grob JJ, Sacco JJ, Gorski KS, Anderson A, Pickett CA, Liu K, Gogas H. Talimogene laherparepvec upregulates immune-cell populations in non-injected lesions: findings from a phase II, multicenter, open-label study in patients with stage IIIB-IVM1c melanoma. J Immunother Cancer. 2021 Mar;9(3):e001621. doi: 10.1136/jitc-2020-001621.
Provided Documents
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Document Type: Study Protocol
Document Type: Statistical Analysis Plan
Related Links
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AmgenTrials clinical trials website
Other Identifiers
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2013-005552-15
Identifier Type: EUDRACT_NUMBER
Identifier Source: secondary_id
20120325
Identifier Type: -
Identifier Source: org_study_id