"neoBREASTIM": Atezolizumab Plus RP1 Oncolytic Immunotherapy in the NeoAdjuvant Setting of Triple-Negative Breast Cancer

Sponsor
Institut Curie
Study ID
NCT06067061
Phase
PHASE1/PHASE2
Status
Terminated

Conditions

  • Triple Negative Breast Neoplasms

Eligibility Criteria

Sex
FEMALE
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Atezolizumab + RP1 — COMBINATION_PRODUCT
    Patients will be treated in a window period (ie 3 treatment cycles). After evaluation, patients that had no increase in ctDNA after 3 cycles (see Definition of ctDNA status) will continue on the same treatment (intratumoral injections of RP1 in combination with Atezolizumab) for a total of 10 treatment cycles prior to surgery.

Study Details

Neoadjuvant treatment is an important part of the treatment strategy for locally advanced TNBC having established a positive and significant correlation of pathologic Complete Response (pCR) with long-term clinical benefit such as Event-Free Survival (EFS) and Overall Survival (OS) as shown via large meta-analysis. Much effort has been made to identify novel agents and new drug combinations that can improve pCR rates in this specific clinical setting, which is the leading rationale to evaluate RP1 oncolytic immunotherapy in combination with Atezolizumab.

Key Dates

Start date
Apr 5, 2024
Status verified
Jun 2025
Primary completion
May 7, 2025
Completion
May 7, 2025

Study Design

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

Arms

  • Experimental: Atezolizumab plus RP1 (Immulytic™) oncolytic immunotherapy
    Atezolizumab IV q2w RP1 (Immulytic™) by imaging-guided intra-tumor (IT) route.

Primary Outcome Measure

Safety of the combination Atezolizumab plus RP1 oncolytic during the safety run-in phase [ Time Frame: 9 months ]

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