NCT03802604

Combination of Talimogene Laherparepvec With Atezolizumab in Early Breast Cancer

Combination of Talimogene Laherparepvec With Atezolizumab in Patients With Residual Breast Cancer After Standard Neoadjuvant Multi-agent Chemotherapy (PROMETEO TRIAL)

• Status: Completed
• Phase: EARLY_Phase 1
• Study type: Interventional
• Enrollment: 28 (actual)
• Sponsor: SOLTI Breast Cancer Research Group · Academic / Other
• Sex: Female
• Age: 18 Years – 99 Years
• Healthy volunteers: Not accepted

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.

Detailed description

Primary objective: • To evaluate the efficacy (as measured by residual cancer burden \[RCB\] class 0/1 rate) of Talimogene Laherparepvec with Atezolizumab given to subjects with operable early breast cancer who present residual disease after neoadjuvant chemotherapy (NAC). Secondary objectives include: * To assess the rate of pathological complete response (pCR) in the breast (pCRB) and breast and axilla (pCRBL) at definitive surgery after neoadjuvant treatment with T-VEC and atezolizumab. * To determine the clinical and radiological ORR of breast tumors to TVEC- atezolizumab given in the neoadjuvant setting. * To assess RCB index in continuous variable and by the 4 RCB class (RCB0, RCB1, RCB2 and RCB 3) after treatment with T-VEC and atezolizumab. * Comparing the expression of a gene signature tracking activated CD8 T-cells at surgery after treatment with T-VEC and atezolizumab with residual disease after NAC. * To evaluate the safety of T-VEC in combination with atezolizumab as assessed by incidence of treatment-emergent and treatment-related adverse events. * Translational and exploratory objectives are included.

Conditions

• Breast Cancer

Interventions

Type	Name	Description
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.

Timeline

• Start date: 2018-12-10
• Primary completion: 2022-04-27
• Completion: 2025-03-18
• First posted: 2019-01-14
• Last updated: 2025-09-09

Locations

4 sites across 1 country: Spain