Expired Study
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Salt Lake City, Utah 84112


Purpose:

The study is a phase 2, multi centered, single arm study designed to evaluate the correlation between CD8+ cell density and objective response rate in subjects with unresected stage IIIB to IVM1c melanoma. This study will also evaluate the safety and tolerability profile of talimogene laherparepvec.


Criteria:

Inclusion Criteria: 1. Provided informed consent prior to initiation of any study-specific activities/procedures 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. ECOG performance status of 0 or 1 6. Adequate organ function Other Inclusion Criteria May Apply Exclusion Criteria: 1. Clinically active cerebral metastases. 2. Bone metastases 3. Primary ocular or mucosal melanoma 4. Active herpetic skin lesions or prior complications of 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 Other Exclusion Criteria May Apply


NCT ID:

NCT02366195


Primary Contact:

Study Director
MD
Amgen


Backup Contact:

N/A


Location Contact:

Salt Lake City, Utah 84112
United States



There is no listed contact information for this specific location.

Site Status: N/A


Data Source: ClinicalTrials.gov

Date Processed: March 16, 2018

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