drugset / Trial / NCT03802604
Combination of Talimogene Laherparepvec With Atezolizumab in Early Breast Cancer
Phase 0
Completed
28 enrolled
SOLTI Breast Cancer Research Group
Amgen · collabRoche Pharma AG · collab
NaSingle-groupOpen-labelTreatment
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.
Timeline
- Start
- 2018-12-10
- Primary completion
- 2022-04-27
- Completion
- 2025-03-18
Publications
- Pascual T, Vidal M, Cejalvo JM, Vega E, Sanfeliu E, Villacampa G, Ganau S, Parreno AMJ, Zamora E, Miranda I, Delgado A, Bermejo B, Segui E, Braso-Maristanty F, de la Cruz-Merino L, Juan M, Galvan P, Gonzalez-Farre X, Chillara S, Villagrasa P, Pfefferle AD, O'Connell CE, Ferrero-Cafiero JM, Oliveira M, Perou CM, Prat A. Talimogene laherparepvec and atezolizumab in HER2-negative breast cancer following neoadjuvant chemotherapy: a window-of-opportunity phase II trial (SOLTI-1503 PROMETEO). Nat Commun. 2026 Feb 16;17(1):2817. doi: 10.1038/s41467-026-69222-5.
- Pascual T, Cejalvo JM, Oliveira M, Vidal M, Vega E, Ganau S, Julve A, Zamora E, Miranda I, Delgado A, Bermejo B, la Cruz-Merino L, Juan M, Ferrero-Cafiero JM, Canes J, Gonzalez X, Villagrasa P, Prat A. SOLTI-1503 PROMETEO TRIAL: combination of talimogene laherparepvec with atezolizumab in early breast cancer. Future Oncol. 2020 Aug;16(24):1801-1813. doi: 10.2217/fon-2020-0246. Epub 2020 Jul 7.
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Atezolizumab | Monoclonal antibody | 840 mg | Intravenous |
| Subject | Talimogene Laherparepvec | Other / unclassified | 1e+08 unknown | Other |