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Combination of Talimogene Laherparepvec With Atezolizumab in Early Breast Cancer

NCT03802604 · Status: COMPLETED · Phase: EARLY_PHASE1 · Type: INTERVENTIONAL · Enrollment: 28

Last updated 2025-09-09

No results posted yet for this study

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.

Conditions

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.

Sponsors & Collaborators

  • Amgen

    collaborator INDUSTRY

  • Roche Pharma AG

    collaborator INDUSTRY

  • SOLTI Breast Cancer Research Group

    lead OTHER

Principal Investigators

  • Aleix Prat · Hospital Clinic of Barcelona

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Max Age
99 Years
Sex
FEMALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2018-12-10
Primary Completion
2022-04-27
Completion
2025-03-18

Countries

  • Spain

Study Locations

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Entities

Drugs
Diseases
Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03802604 on ClinicalTrials.gov