At a glance
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Combination of Talimogene Laherparepvec With Atezolizumab in Patients With Residual Breast Cancer After Standard Neoadjuvant Multi-agent Chemotherapy (PROMETEO TRIAL)
In Brief
A Early Phase 1 clinical trial evaluating Talimogene laherparepvec and Atezolizumab for Breast Cancer. Completed, enrolled 28 participants across 4 sites.
Detailed Summary
PROMETEO is a window opportunity, single arm, exploratory study to evaluate the effect of T- VEC combined with Atezolizumab in women with operable early breast cancer who present residual disease after Neoadjuvant Chemotherapy (NAC). Other eligibility criteria include TNBC or LumB like primary tumor sized at least 1.5 cm, ECOG PS 0-1 and evaluable diagnostic tumor sample.
Study Details
Timeline
Interventions
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.
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.