Combination of Talimogene Laherparepvec With Atezolizumab in Early Breast Cancer

EARLY_PHASE1CompletedINTERVENTIONAL
Enrollment

28

Participants

Timeline

Start Date

December 10, 2018

Primary Completion Date

April 27, 2022

Study Completion Date

March 18, 2025

Conditions
Breast Cancer
Interventions
BIOLOGICAL

Talimogene laherparepvec

Talimogene laherparepvec will be given via intra-tumoral injection at an initial dose of 10\^6 PFU/mL. On week 3 (i.e. 21 days \[± 2\] days), a second talimogene laherparepvec injection will be administered at a dose of 10\^8 PFU/mL. Third, fourth and fifth injections will be administered every 2 weeks (every 14 \[± 2\] days). The maximum volume for each injection will be 4.0 mL.

DRUG

Atezolizumab

Atezolizumab 840 mg will be administered by IV infusion on Day1 week 3, then every 2 weeks (every 14 \[± 2\] days), for a total of 4 treatment courses.

Trial Locations (4)

28050

Centro Integral Oncológico Clara Campal, Madrid

46010

Hospital Clínico universitario de Valencia, Valencia

08035

Hospital Universitari Vall d'Hebrón, Barcelona

08036

Hospital Clínic de Barcelona, Barcelona

Sponsors

Collaborators (1)

All Listed Sponsors
collaborator

Amgen

INDUSTRY

collaborator

Roche Pharma AG

INDUSTRY

lead

SOLTI Breast Cancer Research Group

OTHER