Combination of Talimogene Laherparepvec With Atezolizumab in Early Breast Cancer

Sponsor
SOLTI Breast Cancer Research Group
Study ID
NCT03802604
Phase
EARLY_PHASE1
Status
Completed

Conditions

Eligibility Criteria

Sex
FEMALE
Age
18 Years - 99 Years
Healthy Volunteers
Not accepted

Interventions

  • Talimogene laherparepvec — BIOLOGICAL
    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 — DRUG
    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.

Study Details

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.

Key Dates

Start date
Dec 10, 2018
Status verified
Jul 2025
Primary completion
Apr 27, 2022
Completion
Mar 18, 2025

Study Design

Enrollment
28 participants (actual)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

Arms

  • Experimental: Talimogene laherparepvec + Atezolizumab
    1. Talimogene laherparepvec: Cycle 1 - 10\^6 PFU/mL. Cycle 2, 3, 4 \& 5 - 10\^8 PFU/mL. 2. Atezolizumab 840 mg

Primary Outcome Measure

Rate of residual cancer burden class 0 and 1 (RCB0/1) [ Time Frame: 24 months since first patient in ]

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