Study Complete
Sponsor ID
20140270

Study to Evaluate the Safety/ Efficacy of T-VEC in Japanese Subjects with Unresectable Stage IIIB-IV Malignant Melanoma

Sponsor ID
20140270
Clinicaltrials.gov ID
NCT03064763
EUCTIS ID
N/A
EudraCT ID
N/A

Study Details

There are 2 fold of purposes for this study. 1 is to evaluate safety and tolerability and the other is to study the anti-tumor effects of talimogene laherparepvec in Japanese participants with unresectable stage IIIB-IV malignant melanoma.

Additional Study Details

Phase
Phase 1
Product
talimogene laherparepvec (T-VEC)
Type
Interventional
Masking
None (Open Label)
Enrollment
18
Additional Study Details

Protocol Summary

Primary Outcome Measures

Incidence of dose limiting toxicities (DLTs)of talimogene laherparepvec

Timeframe: 35 days

The anti-tumor activity of T-VEC as assessed by DRR using modified WHO response criteria.

Timeframe: 4 years

Secondary Outcome Measures

Evaluate the anti-tumor activity of talimogene laherparepvec

Timeframe: 4 years

Evaluate overall survival (OS)

Timeframe: 4 years

Locations

Location
Status
Contact Us
Location
National Cancer Center Hospital
Chuo-ku, Tokyo, Japan, 104-0045
Status
Recruiting
Location
National Cancer Center Hospital East
Kashiwa-shi, Chiba, Japan, 277-8577
Status
Recruiting
Location
Shinshu University Hospital
Matsumoto-shi, Nagano, Japan, 390-8621
Status
Terminated
Location
Kumamoto University Hospital
Kumamoto-shi, Kumamoto, Japan, 860-8556
Status
Recruiting
Location
Nagoya University Hospital
Nagoya-shi, Aichi, Japan, 466-8560
Status
Terminated
Location
Osaka International Cancer Institute
Osaka-shi, Osaka, Japan, 541-8567
Status
Terminated
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