Study Complete
Sponsor ID
20140299

Study of Talimogene Laherparepvec With Atezolizumab for Triple Negative Breast Cancer and Colorectal Cancer with Liver Metastases

Sponsor ID
20140299
Clinicaltrials.gov ID
NCT03256344
EUCTIS ID
N/A
EudraCT ID
N/A

Study Details

Approximately 36 DLT-evaluable subjects will be enrolled in this study. The locations of the study will be in the United States, Australia, Europe and Switzerland.

The goal of this study is to evaluate the safety of intrahepatic injection (directly into the liver) of talimogene laherparepvec in combination with intravenously administered atezolizumab in subjects with triple negative breast cancer and colorectal cancer with liver metastases.

Additional Study Details

Phase
Phase 1
Product
talimogene laherparepvec (T-VEC)
Type
Interventional
Masking
None (Open Label)
Enrollment
36
Additional Study Details

Protocol Summary

Primary Outcome Measures

Subject’s incidence of dose limiting toxicities (DLTs)

Timeframe: At the end of Cycle 2 (each cycle is 21 days)

Secondary Outcome Measures

Objective response rate (ORR)

Timeframe: Every 12 weeks (± 28 days) for approximately 24 months

Best overall response (BOR)

Timeframe: Every 12 weeks (± 28 days) for approximately 24 months

Duration of response (DOR)

Timeframe: Every 12 weeks (± 28 days) for approximately 24 months

Disease control rate (DCR)

Timeframe: Every 12 weeks (± 28 days) for approximately 24 months

Durable response rate (DRR)

Timeframe: Every 12 weeks (± 28 days) for approximately 24 months

Progression-free survival (PFS)

Timeframe: Every 12 weeks (± 28 days) for approximately 24 months

Overall survival (OS)

Timeframe: Every 12 weeks (± 28 days) for approximately 24 months

Lesion level responses in injected and uninjected tumor lesions

Timeframe: Every 12 weeks (± 28 days) for approximately 24 months

Locations

Location
Status
Contact Us
Location
Hospital del Mar
Barcelona, Cataluña, Spain, 08003
Status
Recruiting
Location
Inselspital Bern
Bern, Switzerland, 3010
Status
Recruiting
Location
Monash Medical Centre
Clayton, VIC, Australia, 3168
Status
Recruiting
Location
Hopitaux Universitaires de Geneve
Geneva 14, Switzerland, 1211
Status
Terminated
Location
Liverpool Hospital
Liverpool, NSW, Australia, 2170
Status
Recruiting
Location
Hospital General Universitario Gregorio Marañon
Madrid, Madrid, Spain, 28007
Status
Recruiting
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