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Study Complete
Sponsor ID
20120325

Single-arm Trial to evaluate the role of the immune response to talimogene laherparepvec in unresected melanomaTVEC-325

Sponsor ID
20120325
Clinicaltrials.gov ID
NCT02366195
EUCTIS ID
N/A
EudraCT ID
2013-005552-15
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Study Details

The study is a phase 2, multi centered, single arm study designed to evaluate the correlation between cluster of differentiation 8-positive (CD8+) cell density and objective response rate in adults with unresected stage IIIB to IVM1c melanoma. This study will also evaluate the safety and tolerability profile of talimogene laherparepvec.

Additional Study Details

Phase
Phase 2
Product
talimogene laherparepvec (T-VEC)
Type
Interventional
Masking
None (Open Label)
Enrollment
112
Additional Study Details

Protocol Summary

Primary Outcome Measures

Correlation

Timeframe: 24 months following last subject enrolled

Secondary Outcome Measures

Objective Response Rate assessed by Modified World Health Organization (WHO) Response Criteria

Timeframe: 24 months following last subject enrolled

Correlation

Timeframe: 24 months following last subject enrolled

Correlation

Timeframe: 24 months following last subject enrolled

Safety as measured by incidence of adverse events

Timeframe: First dose through 30 days after last dose of talimogene laherparepvec

Change in tumor burden during treatment

Timeframe: 24 months following last subject enrolled

Duration of Response

Timeframe: 24 months following last subject enrolled

Time to Treatment Failure

Timeframe: 24 months following last subject enrolled

Durable Response Rate

Timeframe: 24 months following last subject enrolled

Overall Survival

Timeframe: 24 months following last subject enrolled

Locations

Location
Status
Contact Us
Location
Research Site
Barcelona, Cataluña, Spain, 08036
Status
Recruiting
Location
Research Site
Badalona, Cataluña, Spain, 08916
Status
Completed
Location
Research Site
Valencia, Comunidad Valenciana, Spain, 46014
Status
Recruiting
Location
Research Site
Madrid, Madrid, Spain, 28009
Status
Recruiting
Location
Research Site
Thessaloniki, Greece, 54622
Status
Recruiting
Location
Research Site
Heraklion - Crete, Greece, 71110
Status
Completed
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Study Info
Age
18+ years
Condition
  • Melanoma
    • Sex
    All
    Trial Dates
    Apr 2015 - Jun 2017
    Inclusion and Exclusion 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.Eastern Cooperative Oncology Group (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 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 Other Exclusion Criteria May Apply